HMPL-A830 in Solid Tumors

Sponsor
Hutchmed
Study ID
NCT07718581
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

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.

Key Dates

First listed
Jul 22, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Jun 26, 2028
Completion
Nov 26, 2028

Study Design

Enrollment
147 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Dose Escalation)
  • Experimental: Part B (Dose Optimization)

Primary Outcome Measure

DLTs [ Time Frame: Approximately 12 months ]

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