HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumors, Adult

In brief

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 facts

Study ID

NCT07396584

Run by

Hutchmed

People needed

186

Starts

2026-03-04

Expected to finish

2029-01-30

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Shanghai East Hospital — Shanghai, China (enrolling)
• BRCR Global — Plantation, Florida, United States
• Florida Clinical Trials Group LLC (Plantation) — Plantation, Florida, United States
• Florida Clinical Trials Group LLC (Tamarac) — Tamarac, Florida, United States
• University of Washington/Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Hunan Cancer Hospital — Changsha, China
• Guangxi Medical University Cancer Hospital — Nanning, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China
• The First Affiliated Hospital of Xiamen University — Xiamen, China
• University of California Irvine Medical Center — Orange, California, United States
• Henan Cancer Hospital — Zhengzhou, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.