Delving into the Latest Updates on Izalontamab Brengitecan with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Iza-bren, Zalontamab brengitecan, 依泽朗妥单抗

+ [8]

Target

EGFR x HER3 x Top I

Action

antagonists, inhibitors

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersMouth and Tooth Diseases+ [7]

Active Indication

Metastatic Esophageal Squamous Cell CarcinomaOesophageal squamous cell carcinoma recurrentNasopharyngeal Carcinoma+ [84]

Inactive Indication-

Originator Organization

Systimmune, Inc.

Sichuan Baili Pharmaceuticals Co.,Ltd

Sichuan Biokin Pharmaceutical Co., Ltd.

Active Organization

Baili Bio Chengdu Pharmaceutical Co. Ltd.

Bristol Myers Squibb Co.

Systimmune, Inc.

+ [3]

Inactive Organization-

License Organization

Sichuan Biokin Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Shanghai Maibang Biotechnology Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

China (17 Jun 2026),

Nasopharyngeal Carcinoma

RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Login to view timeline

Structure/Sequence

Boost your research with our ADC technology data.

login

or

view full example data

Boost your research with our ADC technology data.

Sequence Code 43254

Source: *****

Sequence Code 10172664

Source: *****

A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Start Date30 Sep 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07783321

/ Not yet recruitingPhase 3

A Phase III Randomized Controlled Clinical Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with chemotherapy, followed by maintenance therapy with PD-1 monoclonal antibody with or without BL-B01D1, as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Start Date01 Sep 2026

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

NCT07797881

/ Not yet recruitingPhase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma

This Phase II study is a clinical trial exploring the efficacy and safety of BL-B01D1 with or without PD-1 monoclonal antibody in patients with high-risk locally advanced nasopharyngeal carcinoma.

Start Date01 Sep 2026

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

100 Clinical Results associated with Izalontamab Brengitecan

Login to view more data

100 Translational Medicine associated with Izalontamab Brengitecan

Login to view more data

100 Patents (Medical) associated with Izalontamab Brengitecan

Login to view more data

12

Literatures (Medical) associated with Izalontamab Brengitecan

31 Dec 2026·mAbs

Antibodies to watch in 2026

Review

Author: Pinto, Kieran ; Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

01 Jun 2026·ANNALS OF ONCOLOGY

Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody–drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials

Article

Author: Zhou, F ; Li, Y-S ; Ma, Y-X ; Sun, L-H ; Fang, W-F ; Wang, Y-S ; Chen, G ; Shi, J-H ; Hong, S-D ; Hou, X ; Li, X-Y ; Li, C ; Tang, K-J ; He, Z-Y ; Wang, H-Y ; Huang, Y ; Zhao, Y-Y ; Jiang, B ; Wang, Q-M ; Fu, Z-M ; Cui, J-W ; Xiao, S ; Yang, Y-P ; Zhu, Y ; Li, X-L ; Chen, L-K ; Yu, Y ; Zhou, N-N ; Zhang, L ; Lv, D-Q ; Zhao, H-Y ; Zhou, C-C ; Ji, Y-H ; Wu, L ; Zhu, H ; Zhang, G-F ; Zhang, Y-X ; Yang, J

BACKGROUND:

Therapeutic options after progression on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) remain limited for patients with EGFR-mutated non-small-cell lung cancer (NSCLC). Izalontamab brengitecan (Iza-bren; BL-B01D1) is a first-in-class bispecific antibody-drug conjugate targeting EGFR and human epidermal growth factor receptor 3 (HER3) with preclinical and early clinical activity.

PATIENTS AND METHODS:

We pooled individual patient data from a phase Ia/Ib dose-escalation/expansion trial (BL-B01D1-101; NCT05194982) and a phase II multicohort trial (BL-B01D1-203; NCT05880706) in patients with advanced EGFR-mutated NSCLC who had disease progression on prior EGFR TKI therapy. Key endpoints were confirmed objective response rate (cORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. The recommended phase II dose (RP2D) was 2.5 mg/kg on days 1 and 8 every 3 weeks.

RESULTS:

A total of 171 patients were included (data cut-off 30 June 2025; median follow-up 20.5 months). In the pooled population, cORR was 47.4% [95% confidence interval (CI) 39.7% to 55.1%] and DCR was 81.3% (95% CI 74.6% to 86.8%); median DoR was 8.5 months (95% CI 6.9-11.2 months), median PFS was 6.9 months (95% CI 5.5-9.6 months), and median OS was 24.8 months (95% CI 18.5 months to not reached). Efficacy at the RP2D (n = 121) was consistent (cORR 48.8%; DCR 81.0%; median PFS 6.9 months; median OS 24.8 months). In chemotherapy-naive, post-TKI patients treated at the RP2D (n = 50), cORR was 56.0%, DCR was 90.0%, median DoR was 13.7 months, median PFS was 12.5 months, and median OS was not reached. Treatment-related adverse events occurred in 98.8% (grade ≥3: 70.2%), predominantly hematologic; interstitial lung disease was rare (0.6%, all grade 1). Discontinuation for treatment-related adverse events was 1.2%; no treatment-related deaths were reported.

CONCLUSIONS:

In this exploratory post hoc pooled analysis, Iza-bren demonstrated promising antitumor activity and a manageable safety profile in heavily pretreated EGFR-mutated NSCLC. These findings are hypothesis-generating and are being further evaluated in ongoing randomized trials.

01 Apr 2026·JOURNAL OF CLINICAL ONCOLOGY

Izalontamab Brengitecan in Locally Advanced or Metastatic Non–Small Cell Lung Cancer With Actionable Genomic Alterations Outside of Classical EGFR Mutations: A Phase Ib Study

Article

Author: Huang, Yan ; He, Zhiyong ; Wang, Yongsheng ; Yang, Yunpeng ; Zhu, Yi ; Zhang, Li ; Zhao, Hongyun ; Chen, Likun ; Zhu, Hai ; Hou, Xue ; Fang, Wenfeng ; Ma, Yuxiang ; Zhou, Huaqiang ; Xiao, Sa ; Zhao, Yuanyuan ; Li, Yongsheng

PURPOSE:

To evaluate the safety and efficacy of izalontamab brengitecan (iza-bren) in patients with non–small cell lung cancer (NSCLC) harboring actionable genomic alterations (GAs) outside of classical epidermal growth factor receptor ( EGFR ) mutations.

METHODS:

Eligible patients had locally advanced or metastatic NSCLC with prespecific actionable GAs, had progressed after standard treatment and received no more than one previous line of chemotherapy. iza-bren was administered at the dose of 2.5 mg/kg once per day on days 1 and 8 of each 3-week cycle. The primary end point was safety. The secondary end points included objective response rate (ORR), disease control rate (DCR), and duration of response. The exploratory end points included progression-free survival (PFS) and overall survival (OS).

RESULTS:

A total of 83 patients with NSCLC were enrolled in four cohorts: EGFR exon20ins/nonclassical mutations (n = 14), human epidermal growth factor receptor 2 ( HER2 ) mutation (n = 19), KRAS / BRAF / MET mutation (n = 26), and ALK / ROS1 / RET / NTRK fusion (n = 24). The most common grade ≥3 treatment-related adverse events (TRAEs) were thrombocytopenia (51.8%), anemia (44.6%), and neutropenia (43.4%). The most frequent nonhematologic TRAEs of all grades were nausea (49.4%), asthenia (45.8%), stomatitis (44.6%), and diarrhea (38.6%). One case of grade 2 interstitial lung disease was observed. The confirmed ORR was 39.7%, and the DCR was 85.9%. The median PFS was 7.0 months (95% CIs, 5.4 to 10.5), while OS data were immature. Patients with EGFR exon20ins or other nonclassical mutations achieved an ORR of 69.2% with a median PFS of 10.5 months (95% CI, 6.9 to not reached); the HER2 -mutant cohort had an ORR of 52.9% and a median PFS of 7.5 months (95% CI, 5.4 to not reached).

CONCLUSION:

iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical EGFR mutations, especially in EGFR exon20ins/nonclassical and HER2 mutations.

61

News (Medical) associated with Izalontamab Brengitecan

12 Sep 2026

·www.prnewswire.com

SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026

- New global Phase 1 data from a randomized dose-expansion cohort of iza-bren in previously treated EGFR-mutated metastatic NSCLC demonstrate promising antitumor activity and a tolerable safety profile, supporting selection of 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose REDMOND, Wash., Sept. 12, 2026 /PRNewswire/ -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced an abstract for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) taking place September 12 – 15 in Seoul, South Korea. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. The global Phase 1 data being presented at WCLC 2026 evaluated iza-bren in a randomized expansion cohort across three dose levels in patients with EGFR-mutated metastatic NSCLC who had previously received a third-generation EGFR inhibitor. The randomized dose-expansion results demonstrate promising clinical activity, with higher efficacy observed at the 2.5 mg/kg dose level with a manageable safety profile, and support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for IZABRIGHT-Lung01, the global registrational study of iza-bren in EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor. The data further demonstrated the consistent efficacy and safety profile in a global population as shown previously in Chinese patients. These findings further advance the global development of iza-bren in EGFR-mutated NSCLC and build upon the clinical activity reported across multiple tumor types at prior international medical meetings. "The data being presented at WCLC provide important insights into the clinical profile of iza-bren in global patients with previously treated EGFR-mutated metastatic NSCLC," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are encouraged by the promising antitumor activity observed in this randomized dose-expansion cohort, including the increased efficacy observed at the 2.5 mg/kg dose level. Together with the safety and pharmacokinetic findings, these results support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose and represent an important step forward as we advance the global registrational study, IZABRIGHT-Lung01, in patients with EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor." Details of the presentations at WCLC are below: ‍‍ Phase 1 Global Study of Iza-bren in Patients with Metastatic EGFR-mutated NSCLC: Results of the Randomized Dose Expansion Cohort Session Title: OA10 – Novel Antibodies and ADCs - Are They HERalding New Benchmarks? Presentation: OA10.01 Speaker: Alexander Spira (United States) Session Date & Time: Monday Sep 14, 2026 12:00 PM - 1:15 PM (KST) About iza-bren Iza-bren (BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. SOURCE SystImmune, Inc. 21% more press release views with Request a Demo

Phase 1License out/inClinical ResultADCAACR

21 Aug 2026

·allsci.com

CStone to put EGFR/HER3 bispecific ADC to first-in-human test in China

China's National Medical Products Administration (NMPA) has cleared CStone Pharmaceuticals (HKEX: 2616) to begin clinical trials of CS5007, an EGFR/HER3 bispecific antibody-drug conjugate (ADC), in patients with advanced solid tumors. The investigational new drug (IND) application was processed in 23 working days under China's innovative drug clinical trial pathway, allowing CStone to expand its global Phase I program into China after enrolling the first patient in Australia in June 2026. CS5007 was developed using CStone's proprietary ADC platform and combines CS2011, an EGFR/HER3-targeting human IgG1 bispecific antibody, with the company's hydrophilic CSL20 linker and the topoisomerase I inhibitor exatecan as its cytotoxic payload. The dual-targeting design is intended to increase activity across tumors with heterogeneous EGFR and HER3 expression and potentially address HER3-mediated resistance to EGFR-directed therapy. The global Phase I first-in-human study is evaluating CS5007 monotherapy in patients with advanced solid tumors that have progressed following, or are ineligible for, standard treatment. The dose-escalation and expansion study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, while establishing a recommended Phase II dose. Approximately 310 patients are expected to enroll across Australia and China. CS5007 enters a field in which an EGFR/HER3 bispecific ADC has already reached the market. Izalontamab brengitecan (iza-bren), developed by SystImmune and licensed to Bristol Myers Squibb, received NMPA approval for nasopharyngeal carcinoma and has since expanded into esophageal cancer, while also reporting positive Phase III results in triple-negative breast cancer. Like CS5007, iza-bren combines an EGFR/HER3 bispecific antibody with an exatecan-based topoisomerase I inhibitor payload, making it a close structural and mechanistic comparator. CStone said preclinical studies showed CS5007 had antitumor activity across models with different levels of EGFR and HER3 expression. Its ability to differentiate clinically from iza-bren and other ADCs targeting EGFR-family receptors will depend on the therapeutic window generated by its antibody, linker, and conjugation design. CS5007 is part of CStone's Pipeline 2.0 strategy, which emphasizes internally developed multispecific oncology candidates. The portfolio also includes a PD-1/VEGF/CTLA-4 trispecific antibody advancing toward Phase III development in non-small cell lung cancer. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

ADCPhase 1Phase 3Clinical ResultIND

20 Aug 2026

·www.fiercepharma.com

Fierce Pharma Asia—China's IIT scrutiny; Daiichi Sankyo, AZ ph. 3 win; Leo, Tanabe's dermatology deal

China's investigator-initiated trials, once praised for their speediness, have been drawn into scrutiny for a lack of transparency. AstraZeneca and Daiichi Sankyo's Enhertu earned a win in a phase 3 non-small cell lung cancer trial. Tanabe Pharma secured a $435 million payout for global rights to its dermatology rare disease treatment, dersimelagon. And more. 1. After 2 undisclosed gene therapy deaths, can China’s alternative regulatory path still be trusted? The high-speed regulatory pathway credited with fueling China’s biotech boom is under international scrutiny after several previously undisclosed deaths—beginning with two in young children with rare genetic conditions—were uncovered in a matter of weeks. China’s investigator-initiated trials (IIT) allow Chinese hospitals and academics to launch early-stage human trials under a separate regulatory pathway with less oversight than the traditional drug approval process. Fierce talked to experts about what the patient deaths and poor public disclosure could mean for the IIT system. 2. AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure In a pair of phase 3 readouts for niche populations in non-small cell lung cancer, AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu bested Keytruda in first-line HER2-mutant nonsquamous NSCLC, while its Huchmed-partnered Orpathys-Tagrisso combination outperformed platinum-based chemo in Tagrisso-pretreated EGFR-mutated disease. The wins, however, were overshadowed by a phase 3 flop from the investigational bispecific volrustomig, which failed to outdo Keytruda and chemo this week in first-line NSCLC patients whose tumors express PD-L1 at below 50%. 3. Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test Biokin Pharma’s phase 3 trial for iza-bren, a first in-class antibody drug conjugate that targets both EGFR and HER3, met its primary endpoint in an interim analysis, demonstrating significant progression-free survival benefits. The success of the trial conducted in China increases the chances of success for the drug’s global trial, which launches this fall and is spearheaded by global partner Bristol Myers Squibb. 4. Leo ‘really strengthening’ pipeline with $435M deal for Tanabe rare skin disease drug awaiting FDA nod Tanabe Pharma is set to receive $435 million in upfront and near-term milestone payments after a deal with Leo Pharma. In exchange, Leo gets global rights to dersimelagon, a treatment in development for the rare genetic dermatology conditions erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Tanabe announced a phase 3 win for the drug in both indications earlier this year and now awaits an approval decision from the FDA. 5. Sandoz strikes $322M biosimilars deal with Shanghai Henlius Amid growing biosimilar opportunities, Sandoz has entered a collaboration with Shanghai Henlius and procured rights to three early development biosimilars. Per the deal, which could cover as many as 10 biosimilars, Sandoz is paying $100.5 million for the initial assets upfront, and up to $322 million if development milestones are achieved. Third death in China's popular but opaque trials revealed, this time in CAR-T (Endpoints) SK strikes settlement with MSN over future Xcopri generic: reports Kolon TissueGene shrinks workforce after pivotal osteoarthritis trial miss Contractor SK Pharmteco heralds completion of 2 API plants in Ireland Aurobindo unit, China API maker dinged in latest round of FDA warning letters China's top drugmaker Hengrui sees profit growth squeezed by bulk-buying programs (Reuters) Sino Biopharmaceutical rebrands to SBP Group (release)

Phase 3License out/in

100 Deals associated with Izalontamab Brengitecan

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D13053	-	-	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	14 Jul 2026
Oesophageal squamous cell carcinoma recurrent	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	14 Jul 2026
Nasopharyngeal Carcinoma	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	17 Jun 2026

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	NDA/BLA	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	11 Jun 2026
Metastatic castration-resistant prostate cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 Sep 2026
Non-small cell lung cancer stage III	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	28 Aug 2026
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 Aug 2026
Squamous non-small cell lung cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 Aug 2026
Non-squamous non-small cell lung cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	31 Jul 2026
TP53-mutant NSCLC	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	24 Jul 2026
Metastatic Triple-Negative Breast Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	20 Jul 2026
Recurrent Triple-Negative Breast Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	20 Jul 2026
HER2 Positive Breast Cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	06 Jul 2026

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05983432 (IZABRIGHT-Lung01, WCLC2026)	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	80	Iza-bren 2.5 mg/kg	zxsxuqpgaq(xtkesuokic) = ntoikeopjr gbmqncvkaq (hgchrcdskj ) View more	Positive	12 Sep 2026
NCT06500026 \| NCT05194982 (BL-B01D1, Pubmed \| J Clin Oncol)	Phase 1	Extensive stage Small Cell Lung Cancer Second line	52	Izalontamab Brengitecan	ufzrfeqbgu(zzwtobpgoj) = tsvuedpdow dbsevbxdbf (uuxizztfrt, 34.0 - 62.4) View more	Positive	24 Jul 2026
				Izalontamab Brengitecan (second-line treatment)	ufzrfeqbgu(zzwtobpgoj) = acnryuieow dbsevbxdbf (uuxizztfrt, 49.8 - 89.3) View more
NCT06382142 (NATALEE, ASCO2026)	Phase 3	Triple Negative Breast Cancer	325	Izalontamab brengitecan	qjcvkdiamb(upbsvgchxz) = neutropenia (4% vs 0%) kdcahenuri (ttspzaqmcj ) View more	Positive	29 May 2026
				physician’s choice of chemotherapy
NCT06304974 (ASCO2026)	Phase 3	Metastatic Esophageal Squamous Cell Carcinoma Second line	497	Izalontamab brengitecan (iza-bren)	dkovfosmap(rkwxyljsmw) = bzcgxlzejf dauntijnsg (oywmnfofnx, 7.9 - 11.0) View more	Positive	29 May 2026
				Chemotherapy	dkovfosmap(rkwxyljsmw) = cnlppgpubh dauntijnsg (oywmnfofnx, 6.2 - 8.2) View more
NCT05880706 \| NCT05194982 (BL-B01D1-203, Pubmed) Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	171	Izalontamab brengitecan	mgkiazqhzu(zffqoweheh) = zbxyltusaz nxaicqoovo (gpfbbkvcdz, 39.7 - 55.1) View more	Positive	27 Jan 2026
				Izalontamab brengitecan RP2D	mgkiazqhzu(zffqoweheh) = nyttcucunl nxaicqoovo (gpfbbkvcdz ) View more
NCT06304974 (Company_Website) Manual	Phase 3	Esophageal Squamous Cell Carcinoma	-	iza-bren	acagsnvuht(kuxlmpwtoj) = 经独立数据监查委员会（iDMC）判断，iza-bren在预设的期中分析中达到无进展生存期（PFS）和总生存期（OS）双主要终点。 cvgsvxrgwl (fmanndvryp ) View more	Positive	24 Nov 2025
NCT06118333 (BL-B01D1-303, ESMO2025 \| Company_Website \| Lancet \| Pubmed) Manual	Phase 3	Nasopharyngeal Carcinoma	386	Iza-bren 2.5 mg/kgIza-bren 2.5 mg/kg	eeyygflwmq(frxdwzeqil) = erbnwycxvp rqhddzhimu (jplqxzywod ) View more	Positive	17 Oct 2025
				Chemotherapy (capecitabine/gemcitabine/docetaxel)	eeyygflwmq(frxdwzeqil) = gjmzygptht rqhddzhimu (jplqxzywod ) View more
NCT05990803 \| NCT05803018 (ESMO 12025 \| ESMO 22025) Manual	Phase 1/2	Recurrent ovarian cancer	96	iza-bren	ozftihjxul(kniebnqxty) = lxavvhdrya bnrbjkbznh (lirsrgarjc ) View more	Positive	13 Oct 2025
				iza-bren (2.0 mg/kg Q3W)	ozftihjxul(kniebnqxty) = oxmfrsbqal bnrbjkbznh (lirsrgarjc ) View more
NCT05983432 (BL-B01D1-LUNG-101 \| US-Lung-101 study, ESMO 12025 \| ESMO 22025 \| Company_Website) Manual	Phase 1	Solid tumor \| Non-Small Cell Lung Cancer	113	Iza-bren (all doses)	nhgxajrvnm(flogtwhkie) = kzcakvbayo zeaigwrfko (lumedhxxvo ) View more	Positive	13 Oct 2025
				Iza-bren (1.5 mg/kg D1D8 Q3W)	nhgxajrvnm(flogtwhkie) = yxyrexnoky zeaigwrfko (lumedhxxvo ) View more
NCT05785039 (BL-B01D1-201, Pubmed \| J Clin Oncol) Manual	Phase 2	Metastatic urothelial carcinoma	41	BL-B01D1 2.2 mg/kg	ebbuipsmgr(ipomfzzlhn) = iqeupclxae cbordkcxmq (oqpifsepkb, 27.2 - 62.1) View more	Positive	08 Oct 2025
				BL-B01D1 2.5 mg/kg	-

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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

login

or

view full example data

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

Izalontamab Brengitecan

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation