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Solid Tumor, AdultFirst-in-humanDrugPhase 1, Phase 2

What this study is

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.

What's being tested

  • HMPL-A830

    Intervention · DRUG

    Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels

  • HMPL-A830

    Intervention · DRUG

    Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

Study details

Official title
A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
Sponsor
Hutchmed
Conditions
Solid Tumor, Adult
Enrolling
147 people
Starts
2026-09-24
Est. completion
2029-12-15
Design
Open-label, non-randomized, sequential groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗