NCT07396584

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-12-31
• Completion: 2029-01-30
• First posted: 2026-02-09
• Last updated: 2026-03-27

Locations

11 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study