DM005 / Biocytogen, Doma Pharma - LARVOL DELTA

First-in-human study of DM005, an anti-EGFR/c-MET bispecific antibody-drug conjugate, in patients with advanced solid tumors. (ASCO 2026) - P1 | "DM005 is safe and tolerable up to 6.5 mg/kg dose level. In both NSCLCm and NSCLCw pts, and SCLC pts, DM005 has demonstrated an encouraging efficacy with a manageable safety profile. The putative RDE ranges from 4.2 to 6.5 mg/kg which will be further evaluated in phase II trials."

ADC • Bispecific • Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Colorectal Cancer • Constipation • Dental Disorders • Gastric Cancer • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hypotension • Infectious Disease • Leukopenia • Lung Cancer • Nephrology • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Stomatitis • EGFR • MET

A Study of DM005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=208 | Recruiting | Sponsor: Doma Biopharmaceutical?Suzhou?Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=136 ➔ 208 | Trial completion date: Mar 2027 ➔ Sep 2027 | Trial primary completion date: Oct 2026 ➔ Mar 2027

Enrollment change • First-in-human • Phase classification • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

RenLite® transgenic mice provide a high-quality platform for accelerating the development of fully human bispecific antibodies or ADCs worldwide (AACR 2026) - "For example, DM001 (anti-TROP2×EGFR), with good developability, demonstrates potent tumor-suppressive activity in seven various patient-derived xenograft (PDX) models; DM005 (anti-EGFR×MET), with high purity and good conjugation property, exhibits outstanding specificity and anti-tumor efficacy in lung cancer PDX models. These BsADC candidates hold great clinical development potential.Leveraging its RenLite® platform and preliminary screening, Biocytogen has built an antibody library covering over 200 tumor-associated antigens (TAAs). This lets researchers easily conduct rapid screening, flexible pairing, and target synergy validation using in vitro/in vivo efficacy platforms, speeding up BsAb/ BsADC development and boosting clinical translation success of anticancer therapies."

ADC • Bispecific • Preclinical • Lung Cancer • Oncology • Solid Tumor

DM005: An anti-EGFR/c-MET bispecific antibody-drug conjugate for advanced solid tumors. (ASCO 2025) - P1 | "DM005, a bispecific ADC targeting EGFR and c-MET, is a promising therapy for advanced solid tumors. With strong preclinical data, this trial marks a milestone in its clinical development. The ongoing study aims to address significant unmet oncology needs and guide future applications."

Metastases • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • MET

A phase I, multicenter, open-label, first-in-human, dose escalation and expansion study of DM005 in patients with advanced solid tumors (ChiCTR) - P1 | N=176 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

New P1 trial • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • HER-2 • MET • NTRK • ROS1

A Study of DM005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=136 | Recruiting | Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

R&D News | Duoma Pharmaceuticals’ dual-antibody ADC IND approved by FDA, and Phase 1 clinical trial is about to begin [Google translation] (bydrug.pharmcube.com) - "On August 29, Doma Pharmaceuticals, a company in the BioBAY Park , announced that its second bispecific ADC product DM005 has officially obtained IND approval from the US FDA and is about to start phase I clinical trials....The upcoming global Phase I clinical study will recruit patients with various types of solid tumors, including non-small cell lung cancer, head and neck cancer, digestive tract tumors, etc., to evaluate the safety, preliminary efficacy and pharmacokinetic properties of DM005 monotherapy in patients with advanced solid tumors."

IND • New P1 trial • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of DM005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=136 | Not yet recruiting | Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd.

Metastases • New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

DM005, an EGFR × MET bispecific antibody-drug conjugate, showed robust anti-tumor activity in PDX models (SITC 2023) - "Moreover, in multiple patient-derived xenografts of NSCLC and pancreatic ductal adenocarcinoma (PDAC), which co-express EGFR and MET, DM005 demonstrated superior and durable efficacy that outperformed benchmark antibodies at a lower dose (3 mg/kg). Conclusions Collectively, these results suggest that DM005 can be an effective treatment option for EGFR and MET co-expressing tumors and overcome MET-driven EGFR-TKI resistance to improve patient outcomes."

Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MET

Biocytogen Announces 16 Poster Presentations and Booth Exhibition at SITC 2023 (Businesswire) - "Biocytogen Pharmaceuticals (Beijing) Co., Ltd...announced today that the company will be presenting 16 posters and exhibiting at booth 223 at the Society for Immunotherapy of Cancer (SITC) annual conference, taking place from November 1-5, 2023 in San Diego, CA."

Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

YH013, a Common Light Chain Bispecific ADC Targeting EGFR and MET, Improves Preclinical Efficacy Over Its Parental Single-Targeting ADCs (IO-SUMMIT EUROPE 2023) - No abstract available

Preclinical • EGFR

YH013, a novel EGFR x MET bispecific antibody-drug conjugate, exhibits potent antitumor efficacy (AACR 2023) - "Moreover, in multiple patient-derived xenografts of NSCLC and pancreatic ductal adenocarcinoma (PDAC), which co-express EGFR and MET, YH013 demonstrated superior and durable efficacy that outperformed benchmark antibodies at a lower dose (3 mg/kg). Collectively, these results suggest that YH013 can be an effective treatment option for EGFR and MET co-expressing tumors and overcome MET-driven EGFR-TKI resistance to improve patient outcomes."

Clinical • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MET

Biocytogen to Participate in BioJapan2022 to Showcase Innovative R&D Platform, Bispecific ADC Program and Pipeline Progress [Google Translation] (Businesswire) - "Biocytogen Pharmaceuticals...will hold a seminar at the BioJapan 2022 conference on October 14 ( will be held on Friday). The seminar will be divided into three parts and will cover the following topics: Five fully human antibody drug discovery platforms based on RenMice TM: monoclonal antibody platform based on RenMab TM, bispecific antibody platform and bispecific ADC platform based on RenLite ^® , TCR mimic platform, GPCR platform; Progress of 'Project Integrum,' a large-scale project to develop antibody therapeutics against more than 1000 targets by evidence-based in vivo high-throughput screening; Key Assets of Bispecific ADCs Targeting HER2 x TROP2 and EGFR x c-MET (YH012 and YH013, respectively); Phase 1 Results of the Agonistic CD40 Monoclonal Antibody YH003, an Ongoing Multinational Phase 2 Clinical Trial in Patients with Unresectable/Metastatic PDAC."

Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor