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NCT07396584PHASE1, PHASE2Recruiting

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

Hutchmed

Start Date

3/4/2026

Completion Date

1/30/2029

Summary

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.

Detailed 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

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Understood this study and are able to voluntarily sign the informed consent form (ICF); 2. Male or Female, Age ≥ 18 years; 3. Histological confirmed, unresectable, advanced or metastatic solid tumor 4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 5. Life expectancy ≥ 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 Exclusion Criteria: 1. An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus 2. 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 3. Major surgery within 28 days prior to the first dose of study drug 4. Active infection requiring systemic treatment 5. Participant has received a live within 3 months before study enrollment 6. History of inflammatory gastrointestinal diseases 7. Known hypersensitivity to any component of HMPL-A580 8. Pregnant (positive pregnancy test) or lactating;

Interventions

DRUG

HMPL-A580

DRUG

HMPL-A580

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Conditions

Solid Tumors, Adult

Locations

University of California Irvine Medical Center

Orange, California 92868

United States

BRCR Global

Plantation, Florida 33324

United States

Florida Clinical Trials Group LLC (Plantation)

Plantation, Florida 33324

United States

Florida Clinical Trials Group LLC (Tamarac)

Tamarac, Florida 33319

United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Hunan Cancer Hospital

Changsha,

China

Guangxi Medical University Cancer Hospital

Nanning,

China

Shanghai East Hospital

Shanghai,

China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan,

China

The First Affiliated Hospital of Xiamen University

Xiamen,

China

Henan Cancer Hospital

Zhengzhou,

China