RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC31H26ClF4N7O2

InChIKeyQRRJEUIQLZNPIO-UHFFFAOYSA-N

CAS Registry2657613-87-9

Clinical Trials associated with Glecirasib

ChiCTR2600127971

/ Not yet recruitingPhase 4IIT

A Prospective Single-Arm Phase II Clinical Study of Glecirasib Combined with Sacituzumab Tirumotecan as Second-Line Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation

Start Date15 Jul 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

NCT07670013

/ RecruitingPhase 2IIT

A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC

This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.

Start Date01 Apr 2026

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

[+2]

NCT07339839

/ Not yet recruitingPhase 1/2IIT

Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Multi-center, Phase I/II Clinical Study

This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.

Start Date01 Mar 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

100 Clinical Results associated with Glecirasib

100 Translational Medicine associated with Glecirasib

100 Patents (Medical) associated with Glecirasib

Literatures (Medical) associated with Glecirasib

01 Feb 2026·Lancet Respiratory Medicine

Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial

Article

Author: Yu, Yan ; Duan, Jianchun ; Xing, Ligang ; Ye, Feng ; Li, Xiaoyan ; Wang-Gillam, Andrea ; Cao, Baoshan ; Liu, Zhe ; Zhao, Yanqiu ; Xu, Jiachen ; Tang, Kejing ; Bi, Chao ; Zhong, Jia ; Wu, Lin ; Jin, Bo ; Wan, Rui ; Liu, Lian ; Fang, Xuefeng ; Song, Qibin ; Zhao, Jun ; Dong, Xiaorong ; Chen, Jiayan ; Li, Xingya ; Pang, Jiaohui ; Wang, Zhijie ; Chang, Jianhua ; Shi, Jianhua ; Zhuang, Wu ; Wang, Jie ; Fei, Kailun ; Pan, Yueyin ; Fang, Jian ; Sun, Boyang ; Chu, Qian ; Zhang, Li ; Pan, Pinhua ; Bai, Chunmei ; Ding, Yuli ; Shao, Yang

BACKGROUND:

Monotherapy with KRAS^G12C (ie, KRAS Gly12Cys) inhibitors has emerged as a mainstream treatment for patients with KRAS^G12C -mutated non-small-cell lung cancer (NSCLC). Synergistic effects have been observed with the combination of a KRAS^G12C inhibitor and a SHP2 inhibitor in multiple xenograft models. We aimed to evaluate the safety and efficacy of the KRAS^G12C inhibitor glecirasib combined with the SHP2 inhibitor sitneprotafib (JAB-3312; Jacobio Pharmaceuticals, Beijing, China) in patients with KRAS^G12C -mutated solid tumours.

METHODS:

We conducted an open-label, multicentre, single-arm, phase 1/2a trial at 26 hospitals across China. Patients (aged ≥18 years) with locally advanced or metastatic solid tumours harbouring a KRAS^G12C mutation, an Eastern Cooperative Oncology Group performance status score of 0-1, and measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1) were eligible for inclusion in both phases. Patients received oral glecirasib (400 mg or 800 mg once daily) in combination with oral sitneprotafib (2 mg or 3 mg once daily) in seven cohorts evaluating various dose levels and schedules of the two drugs. In phase 1, the primary endpoint was safety assessed by investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0) from first treatment dose to 30 days after the last dose of both agents. In phase 2a, the primary endpoint was objective response rate (ORR) between baseline and disease progression or initiation of anticancer therapy, whichever occurred first, based on the comprehensive assessment of all tumour evaluations by investigators following RECIST (version 1.1). All patients who received at least one dose of combination therapy were included in the safety and efficacy analyses. This trial is registered with ClinicalTrials.gov (NCT05288205) and is currently recruiting.

FINDINGS:

Between May 7, 2022, and Aug 20, 2024, a total of 194 patients with advanced solid tumours were enrolled, of whom 171 (88%) had NSCLC (50 [29%] in phase 1 and 121 [71%] in phase 2a). Median participant age was 65 years (IQR 59-70); 140 (82%) were men and 31 (18%) were women. At data cutoff on Aug 20, 2024, the median follow-up duration was 14·5 months (IQR 11·9-17·1), and 106 (62%) patients had discontinued treatment. Phase 1 concluded with one dose-limiting toxicity (DLT; grade 3 pneumonitis) at the highest dose level (glecirasib 800 mg plus sitneprotafib 3 mg once daily, 1 week on and 1 week off); no DLTs were observed at other dose levels. Across phase 1 and 2a, 167 patients (98%) had at least one treatment-related adverse event, which were grade 3-4 in 78 (46%) patients. The most common treatment-related adverse events (occurring in ≥20% of all 171 patients) were anaemia (105 [61%]), hypertriglyceridaemia (103 [60%]), increased aspartate aminotransferase (95 [56%]), increased alanine aminotransferase (83 [49%]), increased blood bilirubin (78 [46%]), oedema (62 [36%]), increased blood creatine phosphokinase (60 [35%]), neutropenia (54 [32%]), decreased white blood cell count (50 [29%]), and increased bodyweight (44 [26%]). Three (2%) patients discontinued glecirasib and sitneprotafib due to treatment-related adverse events. No grade 5 treatment-related adverse event was reported. The ORR was 71% (72 patients [95% CI 61-79]) in the subgroup of 102 patients with previously untreated NSCLC; 49% (19 patients [32-65]) in the 39 patients previously treated with systemic therapy but naive to KRAS^G12C inhibitors; and 10% (three patients [2-27]) in the 30 patients previously treated with KRAS^G12C inhibitor therapy.

INTERPRETATION:

Glecirasib combined with sitneprotafib showed promising efficacy and manageable safety in patients with advanced KRAS^G12C -mutated NSCLC, particularly among those who had not received previous treatment. These findings support the evaluation of this combination in a phase 3 trial comparing this chemotherapy-free regimen to current standard of care in this patient group.

FUNDING:

Jacobio Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

01 Feb 2026·The Lancet Gastroenterology & Hepatology

Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials

Article

Author: Cao, Baoshan ; Li, Xiaoyan ; Ba, Yi ; Shi, Huaqiu ; Shen, Lin ; Wang-Gillam, Andrea ; Sun, Xin ; Liu, Lian ; Li, Wenhua ; Lu, Shuang ; Yin, Xianli ; Liang, Rong ; Hu, Changlu ; Li, Yongsheng ; Li, Zhen ; Wang, Zhenghang ; Zhang, Yanqiao ; Liang, Xinjun ; Li, Jian ; Luo, Suxia ; Li, Zhihua ; Li, Xingya ; Xiong, Jianping ; Zhu, Liangjun ; Song, Zhengbo ; Xia, Guohao ; Bai, Chunmei ; Zhong, Diansheng ; Fu, Qihan ; Huang, Jing ; Huang, Chenghui ; An, Guangyu ; Ding, Yuli ; Wang, Zhen ; Wang, Feng ; Pan, Wenhui ; Rao, Zhiyue ; Gu, Yanhong

BACKGROUND:

KRAS^G12C mutations are present in around 4% of patients with colorectal cancer and are associated with lower treatment response rates and overall survival. EGFR signalling has been identified as a primary mechanism of resistance to KRAS^G12C inhibitors. We aimed to evaluate the efficacy and safety of a novel, covalent, small molecule KRAS^G12C inhibitor, glecirasib (JAB-21822), as monotherapy or in combination with the anti-EGFR cetuximab, in patients with KRAS^G12C-mutated colorectal cancer.

METHODS:

JAB-21822-1002 was an open-label, non-randomised, dose escalation (phase 1) and expansion (phase 2a) trial evaluating glecirasib monotherapy in KRAS^G12C-mutated solid tumours. JAB-21822-1007 was an open-label, non-randomised, dose escalation (phase 1b) and expansion (phase 2) study evaluating glecirasib plus cetuximab in KRAS^G12C-mutated colorectal, small intestine, and appendiceal cancer. Adult participants (aged ≥18 years) were recruited in China from 17 hospitals for the monotherapy trial and 16 hospitals for the combination trial. Here, we report only on patients with colorectal cancer treated with oral glecirasib at the recommended phase 2 dose (800 mg once daily in 21-day treatment cycles [until disease progression, intolerable toxicity, investigator's discretion, or withdrawal of consent]), pooling phase 1 and 2 data together. In the combination trial, cetuximab was administered intravenously with an initial loading dose of 400 mg/m² in the first week, followed by 250 mg/m² every week or 500 mg/m² every 2 weeks. For this analysis, key eligibility criteria were histologically or cytologically confirmed locally advanced or metastatic colorectal cancer with KRAS^G12C mutation; Eastern Cooperative Oncology Group performance status of 0 or 1; and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST). For phase 1 of both trials, patients must not have responded to, were not suitable for, or refused standard of care. For phase 2 of both trials, patients must have received at least first-line standard of care and had disease progression or intolerance. Primary endpoints for the monotherapy trial were safety (treatment-emergent adverse events, serious adverse events, treatment-related adverse events, dose-limiting toxicity, and clinically significant changes in vital signs, physical examination, and electrocardiography, and clinically significant unexpected laboratory values of grade ≥3) for phase 1 and objective response rate (complete and partial response) for phase 2a. Primary endpoints for the combination trial were dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose for phase 1b and objective response rate for phase 2. The full analysis set was defined as patients with at least one measurable lesion at baseline who received at least one dose of glecirasib in the monotherapy trial, or at least one dose of glecirasib plus cetuximab in the combination trial. The safety analysis set was defined as patients who received at least one dose of glecirasib in the monotherapy trial, or at least one dose of glecirasib or cetuximab in the combination trial. The trials are registered with ClinicalTrials.gov (NCT05009329 and NCT05194995), and are active but no longer recruiting.

FINDINGS:

Between Oct 12, 2021, and Dec 4, 2023, 44 patients with colorectal cancer (27 male and 17 female) in the monotherapy trial received glecirasib 800 mg once daily and comprised the full analysis and safety analysis sets. Between Feb 17, 2022, and Feb 28, 2023, 47 patients with colorectal cancer (22 male and 25 female) in the combination trial received glecirasib 800 mg once daily plus cetuximab and comprised the safety analysis set. One patient was excluded from the full analysis set as they received glecirasib only. Data cutoff was June 30, 2024. Median follow-up was 21·9 months (IQR 20·0-25·5) in the monotherapy trial and 18·7 months (15·9-20·6) in the combination trial. In the monotherapy trial phase 1, 15 patients with colorectal cancer were enrolled. No dose-limiting toxicities, unexpected grade 3 or worse laboratory values, or changes in vital signs, physical examinations, or electrocardiography were observed. 15 (100%) patients had treatment-emergent adverse events (n=8 [53%] grade ≥3), 13 (87%) of 15 reported treatment-related adverse events (n=4 (27%) grade ≥3); five (33%) of 15 patients had serious treatment-emergent adverse events, none were treatment-related. In the combination trial phase 1b, six patients with colorectal cancer were enrolled. No dose-limiting toxicities were observed and the maximum tolerated dose was not reached. The recommended phase 2 dose was chosen as glecirasib 800 mg once daily. Objective response rate was 23% (95% CI 11-38; ten of 44 patients [ten partial responses]) in the monotherapy trial and 50% (35-65; 23 of 46 patients [23 partial responses]) in the combination trial. The most common treatment-related adverse events were anaemia (24 [55%]), blood bilirubin increased (23 [52%]), and conjugated bilirubin increased (17 [39%]) in the monotherapy trial, and rash (39 [83%]), blood bilirubin increased (29 [62%]), conjugated bilirubin increased (17 [36%]), alanine aminotransferase increased (16 [34%]), and anaemia (15 [32%]) in the combination trial. The incidence of grade 3 or 4 treatment-related adverse events was 20% (nine of 44) in the monotherapy trial and 19% (nine of 47) in the combination trial. Two (5%) of 44 patients in the monotherapy trial (febrile neutropenia, n=2) and four (9%) of 47 patients in the combination trial (interstitial lung disease [n=1], pleural effusion and pericardial effusion [n=1], pyrexia [n=1], and rash [n=1]) reported serious treatment-related adverse events. No treatment-related deaths were observed in either trial.

INTERPRETATION:

Glecirasib monotherapy and its combination with cetuximab represent potential treatment options for patients with advanced, refractory colorectal cancer harbouring KRAS^G12C mutations. The promising efficacy and safety support further exploration of glecirasib-based combinations in earlier lines of treatment.

FUNDING:

Jacobio.

TRANSLATION:

For the Mandarin translation of the abstract see Supplementary Materials section.

01 Nov 2025·Cancer Communications

Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials

Article

Author: Jon Zugazagoitia ; Ayala Hubert ; Jian Li ; Diansheng Zhong ; Wenming Wu ; Julia Martínez-Pérez ; Ting Deng ; Zhengbo Song ; Zhiyue Rao ; Ligang Xing ; Jian Zhang ; Xueqin Chen ; Lian Liu ; Zhihua Li ; Guohao Xia ; Andrea Wang-Gillam ; Guilan Wen ; Antonio Calles Blanco ; Xinghu Liu ; Jing Huang ; Lin Wu ; Yanqiu Zhao ; Yanhong Gu ; Yu Yao ; Yuli Ding ; Yongsheng Wang ; Sumei Liu ; Yongsheng Li ; Xingya Li ; Chunmei Bai ; Kuirong Jiang ; Lin Shen

Abstract:

Background:

Glecirasib, an inhibitor of Kirsten rat sarcoma viral oncogene homolog glycine‐to‐cysteine substitution at codon 12 ( KRAS G12C), has exhibited clinical activity in non‐small‐cell lung cancer (NSCLC) and colorectal cancer (CRC). Here, we investigated the efficacy and safety of glecirasib in patients with pancreatic ductal adenocarcinoma (PDAC) and other solid tumors (excluding NSCLC and CRC) that rarely harbor the KRAS G12C mutation but for which effective treatment options remain limited.

Methods:

We conducted and analyzed two open‐label, phase I/II trials in adult patients with KRAS G12C mutant solid tumors, in which glecirasib was administered orally. The two trials had similar eligibility criteria and endpoints but differed in the regions of patient recruitment. We performed a pooled analysis of all patients, excluding NSCLC and CRC, from both trials. The primary endpoint in the pooled population was objective response rate (ORR). Efficacy and safety were assessed in patients who received at least one dose of glecirasib.

Results:

As of June 30, 2024, the pooled analysis included 54 patients who were treated with glecirasib: 32 PDACs, 8 biliary tract cancers (BTCs), 4 small intestinal cancers, 3 gastric cancers, 2 appendiceal cancers, and 5 other tumors. At baseline, 24 received ≥ two prior lines of systemic therapy. Of the 53 efficacy‐evaluable patients, the confirmed ORR was 50.9% (95% confidence interval [CI], 36.8%‐64.9%), with an ORR of 46.9% (95% CI, 29.1%‐65.3%) in PDAC patients. Among other solid tumors, ORR was 71.4% (5/7) in BTC, 100% (4/4) in small intestinal cancer, and 66.7% (2/3) in gastric cancer. Median progression‐free survival and median overall survival were 6.9 and 10.8 months, respectively, in the overall population, and 5.5 and 10.8 months, respectively, in patients with PDAC. Treatment‐related adverse events (TRAEs) of any grade occurred in 94.4% patients, with grade ≥ 3 TRAEs in 27.8%. No fatal TRAEs or TRAEs leading to treatment discontinuation occurred.

Conclusions:

Glecirasib showed promising efficacy and was well tolerated in patients with PDAC and other advanced solid tumors (beyond NSCLC and CRC), warranting further expedited clinical development in this patient population.

Trial registration:

ClinicalTrials.gov identifier: NCT05009329 and NCT05002270.

News (Medical) associated with Glecirasib

09 Jul 2026

·www.prnewswire.com

InxMed Announces Publication in The Lancet Respiratory Medicine Featuring Promising Anticancer Activity of Ifebemtinib in combination with Garsorasib in First-Line non-small cell lung cancer (NSCLC) Harboring KRAS G12C Mutation

NANJING, China, July 9, 2026 /PRNewswire/ -- InxMed Co., Ltd ("InxMed"), a clinical-stage biotechnology company dedicated to developing innovative therapies targeting cancer treatment resistance and metastasis, today announced that the clinical results of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor, in combination with garsorasib (D-1553), a potent KRASG12C inhibitor in first-line KRASG12C-mutant NSCLC, have been published online in The Lancet Respiratory Medicine. The data were derived from a phase Ib/II trial evaluating the efficacy and safety of ifebemtinib plus garsorasib in KRASG12C-mutant solid tumors (NCT06166836/NCT05379946), where ifebemtinib plus garsorasib, as an all‑oral, chemotherapy‑free regimen, demonstrated impressive results in patients with first-line KRASG12C-mutant NSCLC. Promising Antitumor Efficacy and Manageable Safety Profile 33 first-line NSCLC patients with KRASG12C-mutation were enrolled in the single-arm phase II cohort and received ifebemtinib (100mg once a day) and garsorasib (600mg twice a day) orally. By data cutoff on September 16, 2025 reported in this paper, the median follow-up duration was 21.5 months. Ifebemtinib in combination with garsorasib demonstrated a high response rate and durable responses in first-line KRASG12C-mutation NSCLC, increasing the possibility of a paradigm shift, which, if confirmed in currently ongoing phase 3 trial (NCT07174908), could substantially impact the current treatment options for this patient population. Key findings published in this paper: High Response Rates: Of the 33 enrolled patients, 31 were evaluable. The cORR was 82% (27/33) across all enrolled patients and 87% (27/31) among evaluable patients. And tumor shrinkage was observed in all evaluable patients, even in the patient with best overall response of PD. Durable Responses: Among responders, the median Duration of Response (DOR) was Not Reached (NR) (95% CI: 15.2–NE), underscoring the potential of FAK inhibition to prevent or significantly delay treatment resistance. Prolonged survival benefit of PFS and overall survival (OS): The mPFS reached an extraordinary 22.3 months (95% CI: 9.6–NE), with 12-month and 18-month PFS rates standing at 67.9% and 58.2%, respectively. The median OS was 27.8 months (95% CI: 27.8–NE), which remained immature as most patients was censored before 27.8 months. The 12-month and 24-month OS rates were 75.8% and 69.7%, respectively. Manageable safety profile: All 33 patients experienced treatment-emergent adverse events (TEAE). Most of the TEAE were grade 1 or 2; grade 3 or 4 events occurred in 11 (33%) of 33 patients, of which eight (24%) were related to study drugs. No treatment-related death or treatment-related AEs leading to drug discontinuation were reported. "The publication of our long-term follow-up data in The Lancet Respiratory Medicine serves as a momentous validation of our translational science," said Dr. Zaiqi Wang, Chairman and Chief Executive Officer of InxMed. "By pairing KRASG12C inhibitor with our FAK inhibitor ifebemtinib, we have succeeded in blocking this adaptively resistant pathway. An ORR of 82% and a median PFS of over 22 months in the first-line setting represents a paradigm shift, offering these patients a highly potent, completely chemotherapy-free and all-oral option." Overcoming Resistance by FAK Inhibition When Targeting KRAS G12C KRASG12C mutations occur in roughly 12-14% of NSCLC cases. Currently there were six KRASG12C inhibitors approved in previously-treated KRASG12C-mutant NSCLC, including sotorasib and adagrasib (approved in the USA and Europe) and fulzerasib, garsorasib, glecirasib and sosimerasib (approved in China). However, no KRASG12C inhibitors monotherapy or combination regimens were approved in first-line settings partially due to primary or acquired resistance when targeting KRASG12C alone. InxMed's translational research showed that KRASG12C inhibition alone triggers adaptive hyperactivation of the FAK‑YAP signaling pathway, promotes fibrogenesis in the tumor microenvironment, and thereby enhances tumor cell survival. And FAK inhibition by Ifebemtinib disrupts this resistance mechanism, sensitizing tumor cells to KRASG12C inhibition and prolonging the duration of treatment response. Based on these promising clinical data, ifebemtinib has been granted Breakthrough Therapy Designation (BTD) in first-line NSCLC harboring KRASG12C mutation from the China National Medical Products Administration (NMPA). InxMed is progressing its clinical development plan, including an ongoing randomized Phase III confirmatory trial (NCT07174908) intended to support the adoption of this all‑oral, chemotherapy-free regimen as a new standard of care in the front‑line setting. Based on a robust translational medicine foundation and compelling clinical evidence, Ifebemtinib is poised to become a revolutionary therapeutic that could fundamentally reshape the RAS-targeted treatment paradigm. InxMed is strategically driving a comprehensive development program for Ifebemtinib across RAS-mutant tumors, with combination regimens already initiated or in preparation not only with KRAS G12C inhibitors, but also with KRASG12D inhibitors and multi‑RAS inhibitors, among other novel classes, underscoring the company's commitment to transforming the future of RAS-addicted cancers. About Ifebemtinib (IN10018) Ifebemtinib (IN10018) is an orally available, highly potent, and selective small-molecule inhibitor of focal adhesion kinase (FAK). InxMed holds exclusive global development and commercialization rights. Clinically, ifebemtinib has demonstrated excellent safety and tolerability in over 700 subjects globally, showing vast potential as a "backbone" combination partner across multiple modalities, including RAS inhibitors, immune checkpoint blockades, and antibody-drug conjugates (ADCs). It has received multiple Breakthrough Therapy Designations from the NMPA and Fast Track Designation from the U.S. FDA. About InxMed Founded in 2017, InxMed is a late clinical-stage biotechnology company dedicated to tackling a central challenge in cancer therapy—drug resistance caused by tumor defense mechanisms. Our strategy focuses on critical signaling hubs shared across multiple tumor types, most notably the focal adhesion kinase (FAK) and integrin pathways, which play pivotal roles in tumor cell survival and contribute to treatment failure across various therapeutic modalities. In parallel, we target cancer-associated fibroblasts (CAFs) to dismantle the protective barrier around tumor cells. Through these integrated efforts, we aim to redefine cancer treatment and pioneer new frontiers in therapeutic innovation. For more information, please visit en.inxmed.com. SOURCE InxMed Co., Ltd 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 2Fast TrackBreakthrough Therapy

02 Jul 2026

·firstwordpharma.com

Roche's divarasib bests KRAS G12C rivals in late-stage NSCLC study

The KRAS-blocker race has intensified again, with Roche announcing Thursday that its investigational next-generation KRAS G12C inhibitor divarasib demonstrated superiority over approved first-generation agents — Amgen's Lumakras (sotorasib) and Bristol Myers Squibb's Krazati (adagrasib) — on survival outcomes in previously treated patients with non–small-cell lung cancer (NSCLC).The Phase III Krascendo 1 study enrolled 338 previously treated patients with KRAS G12C-mutant advanced or metastatic NSCLC who were randomised to receive either divarasib once daily, Lumakras once daily or Krazati twice daily. Top-line results showed that the head-to-head trial met its primary endpoint of progression-free survival (PFS) and a key secondary goal of overall survival (OS), with divarasib demonstrating clinically meaningful and statistically significant improvements on both measures over Lumakras and Krazati."These results should establish divarasib as a new standard of care for previously-treated…patients with this genetically defined tumour subtype," said Levi Garraway, Roche’s chief medical officer. From a safety perspective, no new signals were identified, with the most common treatment-related events described as manageable and reversible. The company will present detailed results at the European Society for Medical Oncology (ESMO) congress and also submit data to regulatory agencies to support marketing applications.Besides Krascendo 1, Roche's late-stage programme includes Krascendo 2, evaluating a chemotherapy-free combination of divarasib with Merck & Co.'s Keytruda (pembrolizumab) versus chemo-immunotherapy in first-line KRAS G12C-mutant NSCLC, and Krascendo 3, comparing adjuvant divarasib monotherapy against immunotherapy or observation in resected stage II–IIIB disease after standard chemo-immunotherapy.Evolving KRAS landscapeLumakras and Krazati received accelerated FDA approvals for second-line KRAS G12C-mutated NSCLC in 2021 and 2022, respectively. Meanwhile, China granted conditional approval in NSCLC to Innovent Biologics and GenFleet Therapeutics' Dupert (fulzerasib) — the country's first homegrown KRAS G12C inhibitor — in 2024 and subsequently to InventisBio's Anfangning (garsorasib) and Jacobio's glecirasib. Also in the development race are Merck's calderasib, D3 Bio's elisrasib and Eli Lilly’s olomorasib, among several others. Additionally, Revolution Medicines is taking a shot at KRAS-driven NSCLC with elironrasib, a G12C-selective covalent inhibitor and zoldonrasib, which targets KRAS G12D. However, it is the latter's RAS(ON) multi-selective inhibitor daraxonrasib that is perhaps being the most keenly watched.Having already delivered in a Phase III metastatic pancreatic ductal adenocarcinoma study, pending results for daraxonrasib in a late-stage trial for NSCLC could in fact determine the direction that the KRAS landscape takes. For more, see — Spotlight On: Roche sets new bar in lung cancer subset, but could face competition from Revolution's daraxonrasib.

Phase 3Drug ApprovalClinical ResultImmunotherapy

22 Dec 2025

·www.fiercebiotech.com

AstraZeneca fronts $100M for Jacobio\'s clinical-stage pan-KRAS inhibitor

KRAS has been an area of interest for AstraZeneca since 2012.\n AstraZeneca has fronted $100 million to head deeper into the KRAS space, securing the rights to a clinical-stage, multitarget asset from China’s Jacobio Pharma.U.K.-based AstraZeneca has scored the exclusive rights to develop and commercialize the pan-KRAS inhibitor, dubbed JAB-23E73, outside China. On Jacobio’s home territory, the Beijing-headquartered biopharma will jointly work on the therapy with AstraZeneca.JAB-23E73 was developed with Jacobio\'s induced allosteric drug discovery platform, which the company has designed to target multiple KRAS mutation subtypes. So far, the biopharma has been evaluating JAB-23E73 in phase 1 studies in both China and the U.S., with Jacobio pointing to “early signs of anti-tumor activity.”That activity appears to have been enough to attract AstraZeneca, which—beyond the $100 million upfront payment—is also liable to make development and commercial milestone payments of up to $1.91 billion as well as distribute tiered royalties on net sales outside of China.KRAS has been an area of interest for AstraZeneca since 2012, when the pharma licensed an anti-KRAS antisense oligonucleotide, AZD4785, from Ionis Pharmaceuticals. That candidate never progressed past phase 1, with AstraZeneca pulling the plug after wrapping up a trial in 2019, but the company’s research teams continued to work on the target.After discovering the KRAS G12C inhibitor AZD4625, AstraZeneca tweaked the molecule to generate the clinical candidate AZD4747. Then, in 2023, the drugmaker headed to China to license a preclinical KRAS G12D asset from Usynova.“KRAS is one of the most important oncogenes in cancer, with KRAS-mutated tumours driving profound unmet need for patients with pancreatic, colorectal and lung cancers,” Matt Hellmann, M.D., senior vice president, early oncology and precision medicine, oncology R&D, AstraZeneca, said in yesterday’s release.“By advancing KRAS inhibitors like JAB-23E73, and in combination with our diverse oncology portfolio, we aim to accelerate the development of new treatment regimens that have the potential to transform outcomes for patients,” Hellmann added. AstraZeneca isn’t the first pharma to see potential in Jacobio’s pipeline. AbbVie secured the rights to Jacobio’s SHP2 portfolio in 2020 before handing back the assets as part of a portfolio review two years later.More recently, Allist Pharmaceuticals paid about $21 million last year for the rights to one of those SHP2 inhibitors as well as a KRAS G12C inhibitor called glecirasib. Glecirasib demonstrated an overall response rate of 47.9% in a Chinese trial of 119 patients with locally advanced or metastatic KRAS G12C mutated non-small cell lung cancer last year and went on to secure approval in China in May 2025.Jacobio’s co-CEO Yinxiang Wang, Ph.D., said yesterday’s deal with AstraZeneca “marks a significant step forward as we bring our world-class programs to the global stage and maximize the value of our R&D innovation.”“This agreement strengthens Jacobio\'s financial position, accelerates the global development efforts, and expands our presence in the global oncology innovation ecosystem,” added the company, which also has an R&D presence in Boston.

$AstraZeneca fronts $100M for Jacobio\'s clinical-stage pan-KRAS inhibitor$

Phase 1License out/inClinical ResultDrug ApprovalAcquisition

100 Deals associated with Glecirasib

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
KRAS G12C mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	20 May 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	China	Beijing Jiakesi New Drug Development Co. Ltd.	18 Jul 2024
KRAS p.G12C mutant pancreatic cancer	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	16 Oct 2023
Pancreatic Ductal Carcinoma	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	14 Apr 2022
Advanced Colorectal Adenocarcinoma	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
KRAS p.G12C mutant colorectal cancer	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
Small intestine carcinoma recurrent	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
Appendiceal Neoplasms	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	07 Feb 2022
Small intestine carcinoma	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	07 Feb 2022
Non-Small Cell Lung Cancer	Phase 2	United States	Beijing Jiakesi New Drug Development Co. Ltd.	03 Sep 2021
Colorectal Cancer	Phase 2	United States	Beijing Jiakesi New Drug Development Co. Ltd.	03 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06838338 (ASCO2026)	Phase 1	KRAS G12C mutant Colorectal Cancer Second line KRAS G12C mutation	26	Glecirasib combined with standard second-line chemotherapy (FOLFIRI or FOLFOX) and bevacizumab	uisfrihyse(ptsbxekucl) = nulrpphudk amihrlmnbd (ndglhzhszw ) View more	Positive	29 May 2026
NCT05009329 \| NCT05194995 (JAB-21822-1002, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 1/2	KRASG12C mutation	91	Glecirasib 800 mg once daily	ddyafhtugt(quynmdarol) = tjfjlhejua cjkojsillb (ghnruuyqst, 11 - 38) View more	Positive	01 Feb 2026
				Glecirasib 800 mg once daily + cetuximab	ddyafhtugt(quynmdarol) = kmblpsavoy cjkojsillb (ghnruuyqst, 35 - 65) View more
NCT05009329 \| NCT05194995 (Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer KRAS G12C	91	Glecirasib 800 mg once daily	uxmmyidegs(uiyjycejof) = egnqazeygq qiibaeekwy (joomawofrm, 11 - 38) View more	Positive	01 Dec 2025
				Glecirasib 800 mg once daily + Cetuximab	uxmmyidegs(uiyjycejof) = ysmnfoletw qiibaeekwy (joomawofrm, 35 - 65) View more
NCT05009329 \| NCT05194995 (JAB-21822-1002, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 1/2	KRASG12C mutation	91	Glecirasib 800 mg once daily	sxsypkzhhz(tlppraidyr) = yggdtvvcag qttvpzwikx (hqgzitjdka, 11 - 38) View more	Positive	01 Dec 2025
				Glecirasib 800 mg once daily + cetuximab	sxsypkzhhz(tlppraidyr) = jsefrxvnxv qttvpzwikx (hqgzitjdka, 35 - 65) View more
NCT05009329 \| NCT05002270 (Pubmed \| Cancer Commun (Lond))	Phase 1/2	KRAS G12C mutation Solid Tumors KRAS G12C mutation	54	Glecirasib	jkbnnawdlh(uvaafqehek) = aqprouplcz zydlhuqhxd (utsimlswvf, 36.8 - 64.9) View more	Positive	01 Nov 2025
				Glecirasib (PDAC)	jkbnnawdlh(uvaafqehek) = kdcggjxfxi zydlhuqhxd (utsimlswvf, 29.1 - 65.3) View more
NEWS Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C	-	Glecirasib	xywexqevry(vwukxopfwy) = wxjfitghrd hekudcpplv (qwwgkzdyyo ) View more	Positive	16 Jul 2025
				Sotorasib	xywexqevry(vwukxopfwy) = czygmfjsjl hekudcpplv (qwwgkzdyyo ) View more
NCT05009329 \| NCT05194995 (ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer KRAS G12C	44	Glecirasib 800mg QD	zebuzsdtye(tozcjawrzl) = oezkwatjrv yqchrtjgcz (ncwevsrjyf ) View more	Positive	23 Jan 2025
				Glecirasib 800mg QD + Cetuximab	zebuzsdtye(tozcjawrzl) = cnuiaysazt yqchrtjgcz (ncwevsrjyf ) View more
NCT05009329 (Pubmed) Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	119	Glecirasib 800 mg daily	wcllncwlru(wdyxuyzkgg) = ydcisrsefk nqoyonzcbm (oycgauxrrv, 38.5 - 57.3) View more	Positive	06 Jan 2025
NCT05288205 (ESMO2024) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C \| PD-L1	102	Glecirasib plus JAB-3312	qyfcneruxe(rynqnynkjf) = sbcrysolto griuqrxfpo (mohkulanix ) View more	Positive	14 Sep 2024
				Glecirasib plus JAB-3312 (PD-L1 TPS≥50%)	qyfcneruxe(rynqnynkjf) = mefzgyyxxo griuqrxfpo (mohkulanix ) View more
NCT05288205 (PRNewswire) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C	194	JAB-21822+JAB-3312	ureuoviqfh(lujbzvzper) = otyomhpqgb qxehlccntd (midcqbbkjm )	Positive	01 Jun 2024
				JAB-21822+JAB-3312 (frontline)	vcfhvpzkro(pxgwjgscnd) = yiafvdmlxh doogaqcyea (ocawazlvlv ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis