HMPL-A251 / Hutchmed - LARVOL DELTA

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=147 | Recruiting | Sponsor: Hutchmed | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

HUTCHMED Initiates Global Clinical Development of ATTC Candidate HMPL-A251 in Patients with Solid Tumors (GlobeNewswire) - "Study sites are in the US and China. The first patient received the first dose on December 16, 2025, in China. This first-in-human Phase I/IIa, open-label, multicenter clinical study evaluates HMPL-A251 monotherapy in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors."

Trial status • Solid Tumor

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=147 | Not yet recruiting | Sponsor: Hutchmed

New P1/2 trial • Solid Tumor

Discovery of HMPL-A251, a first-in-class HER2-directed antibody-targeted therapy conjugate (ATTC) with a novel PI3K/PIKK inhibitor payload (AACR-NCI-EORTC 2025) - "Notably, HMPL-A251 achieved superior or comparable efficacy to T-DXd at the equivalent dose in most tumor models tested. HMPL-A251 demonstrates strong anti-tumor activity in preclinical models, supporting further clinical evaluation. Initiation of phase I human study is expected in December 2025."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "HMPL-A251 demonstrated HER2-dependent antitumor activity in vitro, potently inhibiting HER2-positive tumor cell growth regardless of PAM pathway alterations, with moderately reduced activity in HER2-low, PAM-altered cell lines. HMPL-A251 also demonstrated a bystander effect on HER2-null cells when co-cultured with HER2-positive cells....HUTCHMED plans to initiate global clinical trials for HMPL-A251 around the end of 2025, followed by multiple global Investigational New Drug (IND) filings for more ATTC candidates in 2026."

IND • New trial • Preclinical • Oncology