HDM2012 / Huadong Medicine - LARVOL DELTA

A multicenter, open-label phase Ia/Ib clinical study in subjects with advanced solid tumors aims to evaluate the safety, tolerability, preliminary anti-tumor activity, and PK characteristics of HDM2012 (ESMO Asia 2025) - P1 | "In phase Ib, the primary endpoints are objective response rate (ORR), safety and tolerability, and pharmacokinetics. In backfill cohort of phase Ia and phase Ib part, only patients with MUC17-positive expression (≥10% tumor cells showing MUC17 membrane protein expression at 1+, 2+, or 3+ intensity) will be enrolled."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • MUC17

A Study of HDM2012 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=129 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Solid Tumor

Huadong Medicine Receives NMPA Approval for HDM2012 Clinical Trials in Advanced Solid Tumors (flcube.com) - "China-based Huadong Medicine...announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its first-in-class category 1 biologic drug HDM2012. This novel antibody-drug conjugate (ADC) is indicated for the treatment of advanced solid tumors."

New trial • Solid Tumor

Translational studies of HDM2012, a novel topoisomerase inhibitor ADC targeting MUC17, in patient derived GC, CRC, PDAC tumor models (AACR 2025) - "Here, we reporting a novel ADC product HDM2012 targeting MUC17, is a potential therapeutic approach for MUC17 positive GC, CRC, PDAC cancer treatment. All the experiment data indicated HDM2012 may be a promising candidate for GI cancer treatment."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • MUC17