HDM2024 / Huadong Medicine - LARVOL DELTA

HDM2024: A novel EGFR and HER3 bispecific antibody-drug conjugate exhibits superior antitumor activity and favorable toxicological profile (AACR 2026) - "Collectively, these results support HDM2024 as a promising therapeutic candidate for solid cancer treatment. A differentiated ADC drug design endows HDM2024 with enhanced pharmacological efficacy and safety advantages, giving it the potential to become a best-in-class drug candidate. HDM2024 is expected to start the clinical trial in Mar 2026."

ADC • Bispecific • Oncology • Solid Tumor • HER-2

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Efficacy of HDM2024 in Participants With Advanced Solid Tumors (ChiCTR) - P1 | N=63 | Sponsor: Shanghai East Hospital; Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor • EGFR • ERBB3

A Study of HDM2024 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor • EGFR • ERBB3

Huadong Medicine…announced that HDM2024, a Category 1 innovative bispecific antibody-drug conjugate (Bs-ADC), has received FDA clearance to initiate a Phase I clinical trial for the treatment of advanced solid tumors (flcube.com) - "The first-in-class candidate simultaneously targets EGFR (HER1) and HER3, delivering a DNA topoisomerase I inhibitor payload via a cleavable linker to block proliferative signaling while exerting direct cytotoxic antitumor effects."

New P1 trial • Solid Tumor