HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

NCT07396584 · tracked via the Priya Life Science USA tracker

Sponsor

Hutchmed

Phase

Phase 1/2

Started

2026-03-04

Last updated

2026-09-18

Condition(s) studied

Solid Tumors, Adult

Investigational drug(s) / intervention(s)

HMPL-A580HMPL-A580

HMPL-A580: Part 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: Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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;

Primary outcome measure(s)

Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) — Approximately 12 months
To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
Overview of Treatment-emergent Adverse Events (TEAEs) — Approximately 12 months
To characterize the safety of HMPL-A580 at RDE(s)
Objective Response Rate (ORR) — At least 8 weeks post dose of first participant up to approximately 24 months
To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)
Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580 — Approximately 12 months
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.

Trial sites (14)

Facility	City	Region	Status
University of California Irvine Medical Center	Orange	California	Not Yet Recruiting
BRCR Global	Plantation	Florida	Recruiting
Florida Clinical Trials Group LLC (Plantation)	Plantation	Florida	Recruiting
Florida Clinical Trials Group LLC (Tamarac)	Tamarac	Florida	Recruiting
Emory Winship Cancer Institute	Atlanta	Georgia	Recruiting
University of Washington/Fred Hutchinson Cancer Center	Seattle	Washington	Not Yet Recruiting
Jilin Provincial Cancer Hospital	Changchun	China	Not Yet Recruiting
Hunan Cancer Hospital	Changsha	China	Not Yet Recruiting
Shandong Cancer Hospital	Jinan	China	Not Yet Recruiting
Guangxi Medical University Cancer Hospital	Nanning	China	Recruiting
Shanghai East Hospital	Shanghai	China	Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	China	Recruiting
The First Affiliated Hospital of Xiamen University	Xiamen	China	Recruiting
Henan Cancer Hospital	Zhengzhou	China	Recruiting

More Hutchmed trials in the USA

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors Recruiting

Other trials for the same condition

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors Active, not recruiting

Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors Recruiting

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors Recruiting

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Recruiting

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07396584 on ClinicalTrials.gov ↗ ← All trials in the USA