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HMPL-A251

Phase 2

Solid Tumors, Adult | Small molecule | Oncology |HUTCHMED (China) Limited|Trials Updated: Dec 28, 2025

HMPL-A251 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2001

HMPL-A251 target and mechanism

Molecular targetEGFR
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

HMPL-A251 clinical trials

HMPL-A251 · 1 trial · 1 indication

Phase 1/2 1
NCT07228247A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid TumorsSolid Tumors, Adult
RECRUITING147 Analytics
PHASE1/PHASE2RECRUITING
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
Solid Tumors, AdultUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
HMPL-A251DRUGSix dose cohorts are planned for the Dose Escalation phase; at least three participants with solid tumors will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN, Zhao, 2023) will be used to guide dose escalation and determine the MTD and/or RDE of HMPL-A251. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.
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Frequently asked questions about HMPL-A251

What is HMPL-A251?

HMPL-A251 is an investigational small molecule being developed by HUTCHMED (China) Limited for the treatment of advanced or metastatic HER2-expressing solid tumors in adults. It is currently in Phase 2 clinical development and has not been approved by the FDA. It is being studied in a biomarker-selected patient population.

What is HMPL-A251 used for?

HMPL-A251 is being evaluated for the treatment of adult patients with advanced or metastatic HER2-expressing solid tumors. It is an investigational therapy and is not approved for any indication. Its use is currently limited to clinical trial participation in a biomarker-selected population.

What does HMPL-A251 target?

HMPL-A251 targets EGFR, a protein receptor. It is a small molecule directed at this target and is being studied in patients with HER2-expressing solid tumors. The trial enrolls a biomarker-selected population, meaning participants are chosen based on specific molecular characteristics of their tumors.

Who is developing HMPL-A251?

HMPL-A251 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is running the clinical program for this small molecule in adult patients with advanced or metastatic HER2-expressing solid tumors.

What phase is HMPL-A251 in?

HMPL-A251 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing study is a Phase 1/2a trial, and the asset is currently listed as being in Phase 2 overall.

What clinical trials is HMPL-A251 in?

HMPL-A251 is being studied in the Phase 1/2a trial NCT07228247, titled a study of HMPL-A251 in participants with advanced or metastatic HER2-expressing solid tumors. The trial is currently recruiting, is uncontrolled, and has a planned enrollment of 147 participants.