HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
Sponsor: Hutchmed
ClinicalTrials ID:NCT07396584
This first-in-human, multicenter, open-label study evaluates HMPL-A580's safety, tolerability, and efficacy in advanced solid tumors. Phase I focuses on dose escalation to determine MTD/RDE, while Phase IIa assesses safety and preliminary efficacy at RDE. Eligible participants are adults with measurable, unresectable tumors, ECOG PS 0-1, and a life expectancy of ≥12 weeks.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Description
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.
To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.
Eligibility Criteria
Inclusion Criteria
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Exclusion Criteria
- An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- Participant has received a live within 3 months before study enrollment
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A580
- Pregnant (positive pregnancy test) or lactating;
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Irvine Medical Center | 92868 | Orange | California |
| BRCR Global | 33324 | Plantation | Florida |
| Florida Clinical Trials Group LLC (Plantation) | 33324 | Plantation | Florida |
| Florida Clinical Trials Group LLC (Tamarac) | 33319 | Tamarac | Florida |
| University of Washington/Fred Hutchinson Cancer Center | 98109 | Seattle | Washington |
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