HMPL-A830 in Solid Tumors
NCT07718581 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 147
Last updated 2026-07-22
Summary
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors\*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
Conditions
- Solid Tumor, Adult
Interventions
- DRUG
-
HMPL-A830
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
- DRUG
-
HMPL-A830
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
Sponsors & Collaborators
-
Hutchmed
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-15
- Primary Completion
- 2028-06-26
- Completion
- 2028-11-26
- FDA Drug
- Yes
Countries
- China
Study Locations
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