HDM2017 / Huadong Medicine - LARVOL DELTA

Preclinical characterization of HDM2017, a novel CDH17-targeted ADC: Potent monotherapy efficacy and synergistic combination potential in gastrointestinal malignancies (ESMO 2026) - No abstract available

ADC • Monotherapy • Preclinical • Oncology • CDH17

A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

A Phase I Study of HDM2017, a CDH17-targeting Antibody Drug Conjugate, in Patients with Advanced Malignant Solid Tumors: Safety and Preliminary Efficacy Results (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P1 data • Oncology • Solid Tumor • CDH17

A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

Discovery of HDM2017, a CDH17-targeting ADC for colorectal cancers (AACR 2025) - "HDM2017ADC exhibited potent cytotoxicity in vitro and in vivo anti-tumor activity in various gastrointestinal cancer models. The preclinical activity and safety profile warrants further clinical development with biomarker strategy. Overall, the preclinical data presented here suggests that HDM2017 ADC has the potential to provide clinical benefit to gastrointestinal cancer patients."

ADC • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17

Huadong Medicine…announced that HDM2017, its independently developed CDH17-targeting antibody-drug conjugate (ADC), has received U.S. FDA Orphan Drug Designation (ODD) for three indications: biliary tract cancer, gastric cancer, and pancreatic cancer (flcube.com)

Orphan drug • Biliary Tract Cancer • Gastric Cancer • Pancreatic Cancer

A Phase 1 Study of HDM2017 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

China‑based Huadong Medicine…announced that its novel antibody‑drug conjugate (ADC), HDM2017 Injection, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors (flcube.com) - "The upcoming studies will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy across multiple CDH17‑positive tumor types....First‑in‑human dosing is expected in the first half of 2025, with subsequent enrollment phases planned thereafter."

New trial • Solid Tumor

Huadong Medicine Secures FDA IND Approval for HDM2017 ADC (flcube.com) - "The decision allows the company to initiate a Phase 1 clinical trial to evaluate HDM2017 in patients with advanced malignant solid tumors."

IND • Solid Tumor