HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

March 24, 2026 updated by: Hutchmed

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Yongchang Zhang
      • Nanning, China
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Song Qu
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Wuhan, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Kunyu Yang
      • Xiamen, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Feng Ye
      • Zhengzhou, China
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Suxia Luo
  • United States
    • California
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California Irvine Medical Center
        • Contact:
    • Florida
      • Plantation, Florida, United States, 33324
      • Plantation, Florida, United States, 33324
        • Not yet recruiting
        • Florida Clinical Trials Group LLC (Plantation)
        • Contact:
      • Tamarac, Florida, United States, 33319
        • Not yet recruiting
        • Florida Clinical Trials Group LLC (Tamarac)
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • University of Washington/Fred Hutchinson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A(Phase I) Dose Escalation
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.
Experimental: Part B(Phase IIa) Dose Expansion/Dose Optimization
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate (DCR)
Time Frame: Approximately 2 years
To assess the preliminary efficacy of HMPL-A580 in solid tumors
Approximately 2 years
progression-free survival (PFS)
Time Frame: Approximately 2 years
To assess the preliminary antitumor activity of HMPL-A580 in selected solid tumors
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 4, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-580-GLOB1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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