HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
Part of paid clinical trials in Orange, California.
- Sponsor
- Hutchmed
- Study ID
- NCT07396584
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Solid Tumors, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HMPL-A580 — DRUGPart A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.
- HMPL-A580 — DRUGPart B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.
Study Details
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
Key Dates
- Start date
- Mar 4, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2028
- Completion
- Jan 30, 2029
Study Design
- Enrollment
- 186 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A(Phase I) Dose Escalation
- Experimental: Part B(Phase IIa) Dose Expansion/Dose Optimization
Primary Outcome Measure
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) [ Time Frame: Approximately 12 months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Irvine Medical Center | Orange | California | 92868 | |
| BRCR Global | Plantation | Florida | 33324 | |
| Florida Clinical Trials Group LLC (Plantation) | Plantation | Florida | 33324 | |
| Florida Clinical Trials Group LLC (Tamarac) | Tamarac | Florida | 33319 | |
| University of Washington/Fred Hutchinson Cancer Center | Seattle | Washington | 98109 |
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