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

Fallopian Tube CarcinomaOvarian Epithelial CarcinomaPlatinum-Resistant Primary Peritoneal Carcinoma+ [56]

Inactive Indication-

Originator Organization

Systimmune, Inc.

Sichuan Baili Pharmaceuticals Co.,Ltd

Active Organization

Bristol Myers Squibb Co.Baili Bio Chengdu Pharmaceutical Co. Ltd.

Systimmune, Inc.

+ [2]

Inactive Organization-

License Organization

Sichuan Biokin Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Shanghai Maibang Biotechnology Co. Ltd.

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (China)

Structure/Sequence

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Sequence Code 43254

Source: *****

Sequence Code 10172664

Source: *****

Clinical Trials associated with Izalontamab Brengitecan

NCT06926868

/ RecruitingPhase 2/3

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Start Date15 Jul 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

NCT07054567

/ Not yet recruitingPhase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + Pembrolizumab Dual Therapy With or Without Bevacizumab (BL-B01D1 + Pembrolizumab ? Bevacizumab) in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

This Phase II study is a clinical trial to evaluate the efficacy and safety of BL-B01D1 + pembrolizumab dual therapy with or without bevacizumab (BL-B01D1 + pembrolizumab ? bevacizumab) in patients with recurrent or metastatic cervical cancer and endometrial cancer.

Start Date01 Jul 2025

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

NCT06978114

/ RecruitingPhase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.

Start Date10 Jun 2025

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

100 Clinical Results associated with Izalontamab Brengitecan

100 Translational Medicine associated with Izalontamab Brengitecan

100 Patents (Medical) associated with Izalontamab Brengitecan

Literatures (Medical) associated with Izalontamab Brengitecan

01 Jul 2024·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

Author: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Rullan, Antonio ; Bhide, Shreerang ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

01 Jul 2024·LANCET ONCOLOGY

BL-B01D1, a first-in-class EGFR–HER3 bispecific antibody–drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study

Article

Author: Chen, Likun ; Yang, Jun ; Guo, Ye ; Chen, Gang ; Zhou, Ningning ; Zhu, Yi ; Zhou, Huaqiang ; Yang, Kunyu ; Zhou, Ting ; Zhang, Li ; Fu, Zhenming ; Xiao, Sa ; Huang, Yan ; Zhao, Shen ; Zhao, Hongyun ; Liu, Qianwen ; Li, Yongsheng ; Fang, Wenfeng ; Zhang, Yaxiong ; Han, Yaqian ; Zhu, Hai ; Ma, Yuxiang ; Zhao, Yuanyuan ; Yang, Yunpeng ; Xue, Jinhui

BACKGROUND:

Antibody-drug conjugates have promising clinical activity in the treatment of solid tumours. BL-B01D1 is a first-in-class EGFR-HER3 bispecific antibody-drug conjugate. We aimed to assess the safety and preliminary antitumour activity of BL-B01D1 in patients with locally advanced or metastatic solid tumours.

METHODS:

This first-in-human, open-label, multicentre, dose-escalation and dose-expansion phase 1 trial was conducted in seven hospitals in China, enrolling patients aged 18-75 years (dose escalation; phase 1a) or older than 18 years (dose expansion; phase 1b), with a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 0-1, and histologically or cytologically confirmed locally advanced or metastatic solid tumours that had progressed on current standard treatment. In the phase 1a i3+3 design, patients received intravenous BL-B01D1 at three different schedules: 0·27 mg/kg, 1·5 mg/kg, and 3·0 mg/kg weekly; 2·5 mg/kg, 3·0 mg/kg, and 3·5 mg/kg on days 1 and 8 of each cycle every 3 weeks; or 5·0 mg/kg and 6·0 mg/kg on day 1 of each cycle every 3 weeks. The primary objectives of phase 1a were to identify the safety, maximum tolerated dose, and dose-limiting toxicity. In phase 1b, patients were treated in two schedules: 2·5 and 3·0 mg/kg on days 1 and 8 every 3 weeks, or 4·5, 5·0, and 6·0 mg/kg on day 1 every 3 weeks. The primary objectives of phase 1b were to assess the safety and recommended phase 2 dose of BL-B01D1, and objective response rate was a key secondary endpoint. Safety was analysed in all patients with safety records who received at least one dose of BL-B01D1. Antitumour activity was assessed in the activity analysis set which included all patients who received at least one dose of BL-B01D1 every 3 weeks. This trial is registered with China Drug Trials, CTR20212923, and ClinicalTrials.gov, NCT05194982, and recruitment is ongoing.

FINDINGS:

Between Dec 8, 2021, and March 13, 2023, 195 patients (133 [65%] men and 62 [32%] women; 25 in phase 1a and 170 in phase 1b) were consecutively enrolled, including 113 with non-small-cell lung cancer, 42 with nasopharyngeal carcinomas, 13 with small-cell lung cancer, 25 with head and neck squamous cell carcinoma, one with thymic squamous cell carcinoma, and one with submandibular lymphoepithelioma-like carcinoma. In phase 1a, four dose-limiting toxicities were observed (two at 3·0 mg/kg weekly and two at 3·5 mg/kg on days 1 and 8 every 3 weeks; all were febrile neutropenia), thus the maximum tolerated dose was reached at 3·0 mg/kg on days 1 and 8 every 3 weeks and 6·0 mg/kg on day 1 every 3 weeks. Grade 3 or worse treatment-related adverse events occurred in 139 (71%) of 195 patients; the most common of which were neutropenia (91 [47%]), anaemia (76 [39%]), leukopenia (76 [39%]), and thrombocytopenia (63 [32%]). 52 (27%) patients had a dose reduction and five (3%) patients discontinued treatment due to treatment-related adverse events. One patient was reported as having interstitial lung disease. Treatment-related deaths occurred in three (2%) patients (one due to pneumonia, one due to septic shock, and one due to myelosuppression). In 174 patients evaluated for activity, median follow-up was 6·9 months (IQR 4·5-8·9) and 60 (34%; 95% CI 27-42) patients had an objective response.

INTERPRETATION:

Our results suggest that BL-B01D1 has preliminary antitumour activity in extensively and heavily treated advanced solid tumours with an acceptable safety profile. Based on the safety and antitumour activity data from both phase 1a and 1b, 2·5 mg/kg on days 1 and 8 every 3 weeks was selected as the recommended phase 2 dose in Chinese patients.

FUNDING:

Sichuan Baili Pharmaceutical.

TRANSLATION:

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

NATURE MEDICINE

A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial

Article

Author: Lu, Zhihao ; Zhu, Yi ; Liu, Chang ; Li, Jian ; Qi, Changsong ; Ge, Sai ; Liu, Dan ; Xiao, Sa ; Wang, Zhenghang ; Zhou, Jun ; Lu, Ming ; Sun, Meili ; Zhang, Miao ; Gao, Shegan ; Ji, Yinghua ; Zhu, Ji ; Zhu, Hai ; Shen, Lin ; Zhang, Panpan ; Wang, Yakun ; Yuan, Jiajia ; Ma, Xuelei ; Zhong, Diansheng ; Peng, Zhi ; Cao, Yanshuo ; Gong, Jifang ; Xue, Ran ; Zhang, Xiaotian

Research on patients with advanced esophageal squamous cell carcinoma (ESCC) who have progressed on immunotherapy remains limited. BL-B01D1 is a first-in-class antibody-drug conjugate consisting of an EGFR-HER3 bispecific antibody bound to a topoisomerase I inhibitor (Ed-04) payload via a cleavable linker. Here, we present safety and efficacy data from a phase 1 study of BL-B01D1, in 82 patients previously treated for ESCC. The primary endpoint was the recommended phase 2 dose. Administered doses were 2.0 (n = 22) and 2.5 (n = 60) mg kg^-1 D1D8 infusion every 3 weeks (Q3W). The confirmed objective response rate (cORR) was 29.3% (24 of 82) in all patients and 32.9% (24 of 73) among evaluable patients. For patients dosed at 2.5 mg kg^-1, cORR was 39.6% (21 of 53) and disease control rate was 79.2% (42 of 53). In the 2.0 mg kg^-1 group, cORR was 15.0% (3 of 20), and the disease control rate was 50.0% (10 of 20). The phase 2 dose was established at 2.5 mg kg^-1 D1D8 Q3W. The incidence of G3 treatment-related adverse events at 2.5 mg kg^-1 was 63.3%; most common adverse events were anemia (28.3%), leukopenia and thrombocytopenia (18.3%, each), and neutropenia (16.7%). Two cases of ≥G3 interstitial lung disease were observed. Overall, BL-B01D1 demonstrated promising efficacy and manageable safety in patients with metastatic ESCC. A further phase 3 clinical trial has already been initiated. ClinicalTrials.gov registration: NCT05262491 .

News (Medical) associated with Izalontamab Brengitecan

10 Jul 2025

·www.fiercepharma.com

Fierce Pharma Asia—Approvals for Innovent, Dizal; BMS partner's bispecific ADC readout

Regulatory approvals for Innovent Biologics and Dizal, and a positive phase 3 readout for Biokin's Bristol Myers Squibb-partnered bispecific ADC made our news this week. In the past two weeks, China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to Johnson & Johnson's Rybrevant, while Biokin said a China phase 3 trial of its Bristol Myers Squibb-partnered bispecific antibody-drug conjugate has met a primary endpoint. And more.1. With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina has approved Innovent Biologics’ mazdutide as the world’s first dual GLP-1/glucagon receptor agonist for chronic weight management. Innovent obtained Chinese rights to the drug from Eli Lilly in 2019. In a Chinese phase 3 trial in patients who were overweight or obese, mazdutide 6mg achieved 14.8% average weight loss at 48 weeks, compared with just 0.5% for placebo.2. Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyAstraZeneca spinout Dizal Pharmaceuticals won an FDA accelerated approval for sunvozertinib for previously treated EGFR ex 20-mutated non-small cell lung cancer. To be marketed as Zegfrovy, the oral drug will compete with Johnson & Johnson’s infused Rybrevant, which recently moved into the first-line setting as part of a chemotherapy combination.3. Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADCA phase 3 trial of Biokin’s bispecific antibody-drug conjugate, iza-bren, has hit at least one primary endpoint. The Chinese phase 3 is testing the EGFRxHER3 ADC in pre-treated nasopharyngeal carcinoma with objective response rate and overall survival as the primary endpoints. Bristol Myers Squibb owns ex-China rights to the drug after paying $800 million upfront.4. Roche’s Chugai inks $250M Gero deal to access age-related disease targetsIn a deal potentially worth $250 million, Roche’s Chugai Pharmaceutical is tapping Gero’s AI-based platform to develop antibodies against age-related diseases. Singapore-based Gero will identify therapeutic targets, while Chugai will utilize its antibody engineering technologies. The Japanese company will hold worldwide rights to drugs born from the collaboration.5. Alphabet's Calico stitches $596M deal for Mabwell's anti-aging assetIn another pact around age-related diseases, Alphabet’s Calico Life Sciences is licensing Mabwell Bioscience’s investigational IL-11-directed therapeutics. The deal includes $25 million upfront and up to $571 million in biobucks. It covers 9MW3811, which is in phase 1 trials across China and Australia, as the Chinese biotech highlights the drug’s potential in idiopathic pulmonary fibrosis. 6. Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKRTorrent Pharma has obtained a 46.39% stake in India’s J.B. Chemicals and Pharmaceuticals from private equity firm KKR for 119 billion rupees ($1.4 billion). Torrent can further purchase another 25% of J.B.’s shares from public shareholders. J.B.’s offerings include some hypertension and eye disease brands and CDMO services.7. Taiho’s DMD asset fails to improve functional motor test results in phase 3 trialTaiho Pharmaceutical’s Duchenne muscular dystrophy candidate pizuglanstat failed to better placebo in a phase 3 study. In ambulatory patients, the oral drug failed to show a significant difference in time to rise from the floor after one year of treatment. Another cohort, conducted in non-ambulatory patients, has also been discontinued.8. Shionogi puts more than $600M on the table for Swiss biotech's antibiotic programShionogi is paying about $6.3 million upfront and up to $604 million in milestones for a preclinical antibiotic asset from BioVersys. The candidate, coded BV500, belongs to the antibiotic class of ansamycin and is being developed for nontuberculous mycobacterial infections.Other News of Note: 9. China approves 4 new drugs, including a global first-in-class medicine10. Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win16. Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)19. Takeda survey finds colon cancer patients feel unheard by HCPs, want more info on diagnosis, treatment20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)

Drug ApprovalPhase 3Phase 2Clinical ResultPhase 1

02 Jul 2025

·endpoints.news

Bristol Myers' China partner touts Phase 3 success for EGFRxHER3 bispecific ADC

Bristol Myers Squibb’s foray into cancer antibody-drug conjugates and bispecifics appears to be bearing fruit. Chinese startup Biokin, which partnered with Bristol Myers through its subsidiary SystImmune in 2023, said that an EGFRxHER3 bispecific ADC called izalontamab brengitecan (iza-bren) hit at least one primary endpoint in an interim Phase 3 readout. Specific data were not disclosed. Wednesday’s announcement represents a boon for Bristol Myers, which has the rights to the drug outside of China. The company is playing catch-up in the bispecific and ADC spaces with companies like AstraZeneca and Merck. AstraZeneca has its own franchise drug Enhertu (HER2-targeting ADC) and the recently approved Datroway (TROP2-targeting ADC). Merck, meanwhile, paid $4 billion upfront to Daiichi Sankyo (which is also partnered with AstraZeneca) for three different ADCs in 2023. Though iza-bren is mechanistically different from those compounds by going after two cancer targets, the drug still commanded a hefty deal. Bristol Myers paid $800 million upfront to Biokin for ex-China rights to the program, and could be on the hook for another $7.6 billion in potential biobucks. In iza-bren’s Phase 3 study, researchers enrolled patients with a form of head and neck cancer known as recurrent or metastatic nasopharyngeal carcinoma. Iza-bren is being tested against physician’s choice of chemo. The trial is measuring overall response rate and overall survival as co-primary endpoints, according to its clinicaltrials.gov page , but Biokin did not specify which endpoint was the one that succeeded. The lead indication for iza-bren is previously untreated triple negative breast cancer for patients who cannot receive anti-PD(L)1 inhibitors. A Phase 2/3 study is expected to start this month.

Phase 3ADCDrug Approval

02 Jul 2025

·www.fiercebiotech.com

Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADC

The study was designed to compare the effect of iza-bren to the physician’s choice of chemotherapy. \n A phase 3 trial of Biokin’s bispecific antibody-drug conjugate (ADC) has hit at least one primary endpoint, boosting the prospects of a candidate that Bristol Myers Squibb licensed outside of China for $800 million upfront.BMS paid the upfront sum, part of a deal worth up to $8.4 billion, in 2023 to secure ex-China rights to izalontamab brengitecan (iza-bren). The candidate is designed to engage EGFR and HER3, receptors involved in the survival and proliferation of epithelial tumors, and deliver a cytotoxic payload to cells that express the proteins.On Wednesday, Biokin reported (PDF) positive topline results from a phase 3 trial of the ADC. The study enrolled patients with recurrent or metastatic nasopharyngeal carcinoma who had received at least two lines of chemotherapy after trying a PD-1/L1 antibody.The study met at least one primary endpoint. Biokin is yet to share data from the trial. The study was designed to compare the effect of iza-bren to the physician’s choice of chemotherapy. Biokin’s Baili Pharmaceutical, the trial’s sponsor, selected objective response rate and overall survival as the primary endpoints for the study. BMS has made triple-negative breast cancer its lead indication for the asset, with a phase 2/3 trial scheduled to start this month, but its Chinese partner’s program could generate evidence to support use in a range of other tumor types. Baili is running studies in indications including cancers of the biliary tract, kidneys, liver, lung and ovaries.Meanwhile, other EGFRxHER3 ADCs are in development. Duality Biotherapeutics and Avenzo Therapeutics secured FDA clearance to start a phase 1/2 trial in May. Biocytogen published preclinical data on a candidate last year. And CStone Pharmaceuticals shared preclinical data on its contender in May.

Phase 3ADCClinical ResultDrug ApprovalClinical Trial Termination

100 Deals associated with Izalontamab Brengitecan

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 May 2025
Ovarian Epithelial Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 May 2025
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 May 2025
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	01 May 2025
Urothelial Carcinoma of the Urinary Bladder	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	25 Mar 2025
Recurrent Lung Small Cell Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	07 Aug 2024
Triple Negative Breast Cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	21 Jun 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	22 May 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	22 May 2024
Hormone receptor positive breast cancer	Phase 3	China	Sichuan Baili Pharmaceuticals Co.,Ltd	24 Apr 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05262491 (Pubmed) Manual	Phase 1	Metastatic Esophageal Squamous Cell Carcinoma	82	BL-B01D1 2.0 mg/kg	sfofkflfjx(xjpcmkuwql) = established at 2.5 mg kg-1 D1D8 Q3W nyfgehxpfs (cjxqcymrmi ) View more	Positive	10 Jul 2025
NCT05262491 (Pubmed) Manual	Phase 1	Metastatic Esophageal Squamous Cell Carcinoma	82	BL-B01D1 2.5 mg/kg		Positive	10 Jul 2025
NCT05194982 (Phase I study of iza-bren (BL-B01D1), ASCO2025)	Phase 1	Small Cell Lung Cancer EGFR \| HER3	58	Iza-bren 2.0 mg/kg	wnwhgqlegl(gniftvnlak) = No ILD was observed auhhiduxhc (qlnsaxqhdp ) View more	Positive	30 May 2025
	Phase 1	Small Cell Lung Cancer EGFR \| HER3	58	Iza-bren 2.5 mg/kg		Positive	30 May 2025
NCT05194982 (Phase I study of iza-bren, ASCO2025)	Phase 1	Non-Small Cell Lung Cancer EGFR exon 20 insertions \| non-classical EGFR mutations \| mutations in HER2 ... View more	73	iza-bren (BL-B01D1) (EGFR exon 20 insertions)	ozhenhdetj(ffsoyguxle) = Only 1 case of G2 ILD was observed lsxfdnthsg (dppkobqtxw ) View more	Positive	30 May 2025
NCT05470348 (Phase I study of iza-bren (BL-B01D1), ESMO_BC2025)	Phase 1	Locally advanced breast cancer HER2-negative	121	iza-bren 2.5 mg/kg	saqqwjcbaw(hesxhlrjiy) = 44.6% qbshhakojx (jmeluutxzd ) View more	Positive	16 May 2025
NCT05262491 (BL-B01D1, ESMO2024) Manual	Phase 1	Biliary Tract Neoplasms	39	BL-B01D1 2.5 mg/kg	klohqsvqvq(qwayasibhg) = jocjbhdjvp iknmpaqfdr (zxxjvqkidv ) View more	Positive	16 Sep 2024
NCT05262491 (ESMO2024) Manual	Phase 1	Esophageal Squamous Cell Carcinoma	83	BL-B01D1 2.0 mg/kg	pshrhohmja(qlfjowomnj) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) hoazkjdopj (gwwjgyjukg ) View more	Positive	16 Sep 2024
NCT05262491 (ESMO2024) Manual	Phase 1	Esophageal Squamous Cell Carcinoma	83	BL-B01D1 2.5 mg/kg		Positive	16 Sep 2024
NCT05785039 (BL-B01D1, ESMO2024)	Phase 1/2	Metastatic urothelial carcinoma	32	BL-B01D1 2.2 mg/kg	gdyowwvgxl(irqoscvkwb) = 22%/0% at 2.2mg/kg mlmadurymg (ndzazdqycu ) View more	Positive	13 Sep 2024
CTR20212923 \| NCT05194982 (Pubmed) Manual	Phase 1	Solid tumor	195	BL-B01D1 0.27 mg/kg	knvjzhkbpt(orxyupnrcb) = rqwuahdrck dmfdqkllvm (jqoruqnfgd ) View more	Positive	01 Jul 2024
NCT05470348 (PRNewswire) Manual	Phase 1	Breast Cancer ER Negative \| HER2 Negative \| PR Negative \| ... View more	127	BL-B01D1	ztpdphpuiz(mtegzylnbr) = ubgmylrscp tzknetzhtv (lgaulrqbcu ) View more	Positive	05 Dec 2023
NCT05194982 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Non-Small Cell Lung Cancer EGFR	114	BL-B01D1	mtlcajcysb(ttefzbrfmt) = yzieocnbnx fxddixuhas (mghwzkfxwy )	Positive	21 Oct 2023
NCT05194982 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Non-Small Cell Lung Cancer EGFR	114	BL-B01D1 (EGFRmut)	vqrpttintq(uwdaykyfta) = gidvkjxvva ctcktoxhou (dpxyirsfqq, 75.2 - 97.1) View more	Positive	21 Oct 2023

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