A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC

Start Date25 Apr 2023

Sponsor / Collaborator

Zhejiang JinFang Pharmaceutical Co., Ltd.

NCT05699993 / CompletedPhase 1

An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

Start Date10 Mar 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20230052 / CompletedPhase 1

在健康受试者中评价伊曲康唑或右美沙芬与IBI351药物相互作用的开放、双周期临床研究

[Translation] An open-label, two-period clinical study to evaluate the drug-drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects

评价伊曲康唑对健康受试者口服IBI351后药代动力学影响；IBI351对健康受试者口服代谢酶CYP2D6敏感底物右美沙芬后药代动力学影响。

[Translation]

To evaluate the effect of itraconazole on the pharmacokinetics of IBI351 after oral administration to healthy subjects; to evaluate the effect of IBI351 on the pharmacokinetics of dextromethorphan, a sensitive substrate of CYP2D6, after oral administration to healthy subjects.

Start Date06 Mar 2023

Sponsor / Collaborator

Zhejiang JinFang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Fulzerasib

100 Translational Medicine associated with Fulzerasib

100 Patents (Medical) associated with Fulzerasib

News (Medical) associated with Fulzerasib

19 Jun 2024

·www.prnewswire.com

GenFleet Receives IND Approval from China's NMPA for GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, in a Phase I/II Clinical Trial Treating Advanced Solid Tumor Patients with KRAS G12D Mutation

SHANGHAI, June 19, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced China's National Medical Products Administration (NMPA) has approved the clinical trial application for GFH375 (VS-7375) in an open-label, multi-center phase I/II study targeting advanced solid tumor patients with KRAS G12D mutation. G12D mutation is the most prevalent KRAS mutation detected in human cancers, and no G12D-targeted therapies have been approved yet. GFH375 is a highly potent and selective KRAS G12D inhibitor targeting both "ON" (GTP-bound) and "OFF" (GDP-bound) states of the protein. According to the latest preclinical findings posted at 2024 AACR annual meeting, GFH375 demonstrated preliminary safety data, favorable oral bioavailability and potent efficacy across preclinical models; moreover, GFH375 holds the potential for treating G12D-mutant cancers with brain metastases. GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) in 2023 to advance three oncology programs. The first program selected is GFH375, which represents a significant milestone as the GenFleet's first product to achieve overseas out-licensing at preclinical stage and the IND approval in China, underscoring the company's expertise in the development of RAS-targeted therapies. The study (GFH375X1101) will be conducted at ~40 hospitals, including the prominent Shanghai Chest Hospital. In phase I, the study aims to evaluate the safety/tolerability and preliminary efficacy of GFH375 in advanced G12D-mutant solid tumor patients. Additionally, the phase I trial will determine the recommended phase II dose (RP2D). Progressing into Phase II, the study will further assess the efficacy of GFH375 for patients of advanced solid tumors including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC) – three cancer types with highest prevalence of G12D mutation; the study will also investigate the underlying mechanisms of patients' response and resistance to the treatment. "I am excited that the clinical trial application for GFH375 has been approved. The therapeutic landscape for G12D-mutant cancers remains challenging with limited treatment options, highlighting the significant unmet medical needs in this population. The G12D mutation is one of the most prevalent KRAS mutations and the development of G12D-targeted therapies has garnered significant attention recently. We eagerly await favorable safety and efficacy outcome for GFH375 in the upcoming trial, with the hope of introducing a novel life-saving treatment for patients." stated Dr. Shun Lu, professor of Dept. of Medical Oncology, Shanghai Chest Hospital. "We are delighted to enter in a clinical trial to assess the clinical benefits of our G12D targeted program in monotherapy setting and explore the possibilities of synergistic effects that may arise from potential combination regimen in future. GenFleet's expertise in developing RAS-targeted therapies has been exemplified by the successful development of fulzerasib (GFH925, a KRAS G12C inhibitor) and the NDA acceptance of its monotherapy for NSCLC in China. This allows GenFleet to be well positioned to advance our second RAS pathway inhibitor GFH375 into the clinical trial, as well as other RAS-inhibiting therapies in our pipeline." stated Yu Wang, Ph.D/M.D., Chief Medical Official of GenFleet. References: 1. Impact of KRAS mutations and co-mutations on clinical outcomes in pancreatic ductal adenocarcinoma, NPJ Precision Oncology, Feb. 2024 2. Next batter up! Targeting cancers with KRAS G12D mutations, Trends in Cancer (Cell Press), Nov. 2023 3. Pan-KRAS inhibitor disables oncogenic signaling and tumor growth, Nature, May 2023 About KRAS G12D mutation and GFH375 RAS proteins, in active GTP-bound or inactive GDP-bound form, are binary molecular switches controlling cellular responses in signaling pathways including RAS-RAF-MEK-ERK and PI3K/AKT/mTOR. Three RAS genes encode for protein isoforms, namely Kirsten Ras (KRAS), Harvey Ras (HRAS) and Neuroblastoma Ras (NRAS), and KRAS is the most frequently mutated oncogene in humans. Among KRAS mutations, G12D, G12V, and G12C represent the top three most frequently mutated alleles. KRAS G12D mutation is commonly found in pancreatic ductal adenocarcinoma, colorectal cancer, and lung adenocarcinoma. A large percentage of patients harboring KRAS G12D mutation are found without smoking history and with poor response to PD-1 inhibitors. Mutant-selective G12D inhibitors hold promise to benefit large segments of KRAS-driven PDAC patients since KRAS G12D alterations are the most frequently occurring somatic change in PDAC patients (about 40%) who are reported to have an overall 5-year survival rate lower than 10%. GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor designed to target the GTP/GDP exchange, thereby disrupting the activation of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated that the inhibition of GFH375 on tumor growth is enhanced along with the increase in dosage and duration of treatment; GFH375 also demonstrated low off-target risk in kinase selectivity and safety target assays. GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs related to RAS pathway-driven cancers. The risk-sharing structure of the collaboration provides Verastem Oncology a milestone-based option to license up to three compounds. The licenses would give Verastem Oncology development and commercialization rights outside of China while GenFleet would retain rights inside of the Chinese mainland, Hong Kong, Macau, and Taiwan. About GenFleet Therapeutics GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology. Based on the deep understanding of disease biology and translational medicine, GenFleet's proprietary and fully integrated R&D platform highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs, many of which have entered multi-regional clinical trials across China (including Taiwan), the United States, Europe and Australia. To date, GenFleet has over 5 clinical studies encompassing IND stage to phase II studies and completed co-development partnerships with numerous publicly listed companies worldwide. GenFleet is expected to progress additional programs into the clinic, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years. SOURCE GenFleet Therapeutics

Phase 1Phase 2INDAACR

19 Apr 2024

·www.prnewswire.com

GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior lines of therapies, or intolerant to the last treatment. The primary objective is to compare the efficacy of GFH925 versus the current standard of care. A pooled analysis from the two phase I studies was published at ESMO Asia 2023: GFH925 monotherapy for CRC demonstrated efficacy (including objective response rate and median progression-free survival) superior to other single-agent KRAS G12C inhibitors and comparable to the combination regimens of other G12C inhibitors with anti-EGFR antibodies. "We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC. We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients. This is a significant step forward in the development of GFH925, paving the way for its potential future use as a front-line treatment for CRC. "stated Yu Wang, Ph.D/M.D., Chief Medical Official of GenFleet. "Additionally, the study of GFH925 in combination with cetuximab is ongoing in Europe treating advanced NSCLC in the first-line setting and the phase II trial has completed the enrollment; the preliminary data analysis of this combination study, accepted as a late breaking abstract, has been selected for oral presentation during the 2024 ASCO annual meeting. GFH925's global development reflects GenFleet's forward-thinking strategy, the expertise of our clinical team and the deep understanding of biology for our RAS-targeted pipeline." According to GLOBOCAN 2022 report, there were over 1.9 million new CRC cases and over 900,000 deaths worldwide, both accounting for over 9% in all cancer types. Approximately 40% of CRC patients carry KRAS mutations, with the prevalence of mutated G12C allele in CRC being only next to NSCLC. Standard first- and second-line treatments are based on combination of fluoropirimidines plus oxaliplatin or irinotecan, associated to an anti-EGFR (RAS wild type) or anti-VEGF antibody. Among the patients that eventually develop metastases to liver, lung and/or peritoneum, KRAS mutation in CRC is a prognostic factor associated with advanced disease status, poor tumor differentiation, distant metastasis, and inferior survival. On the other hand, a limited number of CRC patients receive checkpoint inhibiting therapies, especially when compared with patients of other hot tumors such as lung cancer; more targeted agents with a safety profile are called for those patients. Moreover, prior-line EGFR inhibitors may lead to secondary KRAS mutations. There is consequently a substantial unmet clinical need, coupled with vast market potential, for developing innovative KRAS inhibitors. References: 1. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA: A Cancer Journal for Clinicians, Apr. 2024 2. Targeting KRAS G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver, International Journal of Molecular Science, Mar. 2024 3. Disease Burden of Total and Early-Onset Colorectal Cancer in China from 1990 to 2019 and Predictions of Cancer Incidence and Mortality, Clinical Epidemiology, Feb. 2023 4. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors, Precision Oncology, Dec. 2022 About GFH925 and RAS The clinical data of two phase I studies of GFH925 monotherapy for CRC treatment were posted at 2023 ESMO Asia. For 600mg BID patients (n=48), confirmed ORR and DCR were of 45.8% and 89.6% respectively; median PFS was 7.6 months. GFH925 the first China-developed KRAS G12C inhibitor that has its NDA submission accepted and granted with Priority Review Designation by NMPA. GFH925 also received Breakthrough Therapy Designations this year for treating advanced KRAS G12C-mutant NSCLC patients that have received at least one systemic therapy and CRC patients who have received at least two systemic therapies. RAS protein family can be divided into KRAS, HRAS and NRAS categories. KRAS mutations are detected in nearly 90% of pancreatic cancer, 30-40% of colon cancer, and 15-20% lung cancer patients. The occurrence of KRAS G12C mutation subset is more frequently observed than those with ALK, ROS1, RET and TRK 1/2/3 mutations combined. GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest. SOURCE GenFleet Therapeutics

Phase 2Phase 1Phase 3Breakthrough TherapyClinical Result

09 Apr 2024

·www.prnewswire.com

GenFleet Therapeutics Announces Potent Anti-tumor Efficacy of GFH375, an Oral KRAS G12D (ON/OFF) Inhibitor, and its Potential in Combination Therapy with RAF/MEK Clamp at 2024 AACR Annual Meeting

SHANGHAI and SAN DIEGO, April 9, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today unveiled the latest research findings of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, at the poster presentation of the 2024 American Association for Cancer Research (AACR) Annual Meeting. GFH375 (VS-7375) is a highly potent and selective KRAS G12D inhibitor targeting both "ON" (GTP-bound) and "OFF" (GDP-bound) states of the protein. With preliminary safety data, favorable oral bioavailability and potent efficacy across preclinical models, GFH375 also holds the potential for treating KRAS G12D mutant cancers with brain metastases. "G12D mutation is the most prevalent KRAS mutation detected in human carcinomas, and no G12D-targeted therapies have been approved yet. Preliminary research has shown potent efficacy and safety of orally administered GFH375 in animal models. Additionally, GenFleet's GFH925 (KRAS G12C inhibitor) has had its New Drug Application accepted with Priority Review Designation in China. GenFleet is well-positioned to rapidly deploy its proven expertise in developing RAS pathway inhibitors to deliver more cutting-edge innovative therapies. "stated Fusheng Zhou, Ph.D., Vice President of GenFleet's Drug Discovery Department. Preclinical research also demonstrated the combination of avutometinib (RAF/MEK clamp) and GFH375 confers enhanced anti-tumor efficacy relative to either agent alone, indicating potential for future clinical combination. Avutometinib in combination with defactinib (FAK inhibitor) is being developed by Verastem Oncology with clinical development across multiple indications and was granted breakthrough therapy designation for the treatment of patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status and after one more prior lines of therapy, including platinum-based chemotherapy. GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) in 2023 to advance three oncology programs, the first program selected is GFH375. Abstract Title: GFH375 (VS-7375): An oral, selective KRAS G12D (ON/OFF) inhibitor with potent anti-tumor efficacy Abstract No. : 3318 Original mechanism targets both active and inactive KRAS G12D GFH375 inhibits GTP-bound KRAS G12D and its binding with downstream proteins such as RAF; the drug candidate also targets the GDP-GTP exchange to inhibit the activation of KRAS G12D. Potent single agent anti-tumor efficacy of GFH375 and its potential for treating KRAS G12D mutant cancers with brain metastases GFH375 potently and selectively inhibits phospho-ERK signaling and proliferation in KRAS G12D mutant tumor cells. GFH375 also accumulates in tumor tissue and elicits sustained inhibition of the protein following a single oral administration. GFH375 induces tumor regression in multiple KRAS G12D CDX tumor models via oral administration. It also demonstrates potent anti-tumor activity in an intracranial CDX tumor model, which suggests the potential of GFH375 as a treatment for KRAS G12D mutant cancers with brain metastases. Combination of GFH375 and avutometinib enhances anti-tumor efficacy while retaining favorable toxicity profile in vivo The combination of GFH375 and avutometinib enhances anti-tumor efficacy and leads to more significant tumor regression over either drug candidate alone. Meanwhile, the results exhibit favorable toxicity profile of this combination. About RAS and KRAS mutations RAS proteins, in active GTP-bound or inactive GDP-bound form, are binary molecular switches controlling cellular responses in signaling pathways including RAS-RAF-MEK-ERK and PI3K/AKT/mTOR. Three RAS genes encode for protein isoforms, namely Kirsten Ras (KRAS), Harvey Ras (HRAS) and Neuroblastoma Ras (NRAS), and KRAS is the most frequently mutated oncogene in humans. About KRAS G12D and GFH375 Among KRAS mutations, G12D, G12V, and G12C represent the top three most frequently mutated alleles. KRAS G12D mutation is commonly found in pancreatic ductal adenocarcinoma, colorectal cancer, and lung adenocarcinoma. A large percentage of patients harboring KRAS G12D mutation are found without smoking history and with poor response to PD-1 inhibitors. Mutant-selective G12D inhibitor holds promise to benefit large segments of KRAS-driven PDAC patients since KRAS G12D alteration is the most frequently occurring somatic change in PDAC patients (about 40%) who are reported to have an overall 5-year survival rate lower than 10%. GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor designed to target the GTP/GDP exchange, thereby disrupting the activation of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated that the inhibition of GFH375 on tumor growth is enhanced along with the increase in dosage and duration of treatment; GFH375 also demonstrated low off-target risk in kinase selectivity and safety target assays. GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs related to RAS pathway-driven cancers. The risk-sharing structure of the collaboration provides Verastem Oncology a milestone-based option to license up to three compounds. The licenses would give Verastem Oncology development and commercialization rights outside of China while GenFleet would retain rights inside of mainland China, Hong Kong, Macau, and Taiwan. About GenFleet Therapeutics GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology. Based on the deep understanding of disease biology and translational medicine, GenFleet's proprietary and fully integrated R&D platform highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs, many of which have entered multi-regional clinical trials across China (including Taiwan), the United States, Europe and Australia. To date, GenFleet has over 5 clinical studies encompassing IND stage to phase II studies and completed co-development partnerships with numerous publicly listed companies worldwide. GenFleet is expected to progress additional programs into the clinic, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years. SOURCE GenFleet Therapeutics

Phase 1Breakthrough TherapyPhase 2Clinical Result

100 Deals associated with Fulzerasib

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Kanglong Huacheng (Ningbo) Biomedical Co., Ltd.	24 Nov 2023
KRAS G12C mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Innovent Biologics, Inc.	24 Nov 2023
Colorectal Cancer	Phase 3	US	Genfleet Therapeutics (Shanghai), Inc.Startup	-
KRAS G12C mutation Solid Tumors	Phase 2	CN	Zhejiang JinFang Pharmaceutical Co., Ltd.	13 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 2	CN	Innovent Biologics (Suzhou) Co. Ltd.	10 Sep 2021
Non-Small Cell Lung Cancer	Phase 1	CN	Zhejiang JinFang Pharmaceutical Co., Ltd.	13 Feb 2023
Advanced Lung Non-Small Cell Carcinoma	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	20 Sep 2022
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	20 Sep 2022
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 Sep 2022
KRAS G12C mutant Colorectal Cancer	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	18 Aug 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05756153 (KROCUS, ASCO2024) Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C mutated	27	Fulzerasib+ Cetuximab	ngbwxvejih(cmccjhbyoj) = rvlzxgcfxx kdojgjotgr (olwgfkophg, 56.3 - 94.3) View more	Positive	02 Jun 2024
NCT05005234 (NEWS) Manual	Phase 1	KRAS G12C mutant Non-small Cell Lung Cancer Second line KRAS G12C	67	IBI351	hbavyxquta(wjyfmkiijb) = ejgppxbvia cisvivhhgy (trihuqouee ) View more	Positive	04 Dec 2023
NCT05005234 (NEWS) Manual	Phase 1		67	IBI351 (600 mg 每天两次)	hbavyxquta(wjyfmkiijb) = nwlyqxigwg cisvivhhgy (trihuqouee ) View more	Positive	04 Dec 2023
NCT05005234 (NEWS) Manual	Phase 1	KRAS G12C mutant Non-small Cell Lung Cancer Second line KRAS G12C	55	IBI351	qzsmhvvxuy(aundfcfzvr) = ippukfghft jaktciiqhj (gqyfcmsjen ) View more	Positive	04 Dec 2023
NCT05005234 (NEWS) Manual	Phase 1		55	IBI351 (RP2D)	qzsmhvvxuy(aundfcfzvr) = wvadtwvsku jaktciiqhj (gqyfcmsjen ) View more	Positive	04 Dec 2023
NCT05005234 \| NCT05497336 (ESMO_ASIA2023) Manual	Phase 1	KRAS G12C mutant Colorectal Cancer KRAS G12C	56	IBI351	idpevxrzid(czwssbtksx) = kfheexcerk wsiwjhppwv (zqluyaexkd, 31.4-60.8) View more	Positive	02 Dec 2023
NCT05005234 (ESMO_ASIA2023)	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	116	IBI351 600 mg	hiuxqxkyyo(ezqkcptjrf) = ivivtqfijh fpuggkitmb (frqmjcodmk, 37.2 ~ 56.0) View more	Positive	01 Dec 2023
NEWS Manual	Phase 1	KRAS mutant Non-small Cell Lung Cancer Second line KRAS G12C	67	IBI351	pcdwdkspkv(yktdfuvbsu) = gbuzghwzdq taehxueppu (tfcjoqymgi ) View more	Positive	24 Nov 2023
NEWS Manual	Phase 1		67	IBI351 (600mg BID)	ytvhybfxqi(gbyjzrnjbc) = rgktlfsvwk cuwqchnjch (qqoxrpvyoi, 39.8 - 91.7) View more	Positive	24 Nov 2023
NCT05005234 \| NCT05497336 (ASCO2023) Manual	Phase 1	Solid tumor KRASG12C mutation	32	IBI351 600mg BID	shfapjttsg(writfqxxnh) = niukgzylem yjadxafntq (ycpyapatdi ) View more	Positive	31 May 2023
NCT05005234 (AACR2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	74	IBI351	pnctczaeti(fpbhupgfiy) = jvvnvndiza sellzdxrou (tqcrnsmpve )	Positive	14 Apr 2023
NCT05005234 (AACR2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	74	IBI351 (response-evaluable NSCLC pts)	ioeikuljef(dukqxnjtht) = fxumofeevh mgxcjeqrlh (vmgrskxjek, 83.4 - 97.5) View more	Positive	14 Apr 2023
NCT05005234 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors KRAS G12C	15	IBI351	roopeolefd(iknxjnsanm) = zffmuftlny gqyiapnpwi (ojhurchzic ) View more	Positive	02 Jun 2022

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