HMPL-A580 for Advanced or Metastatic Solid Tumors

This study is testing a new drug called HMPL-A580 for people with advanced or metastatic (spread to other parts of the body) solid tumors that cannot be removed by surgery. The main goals are to find a safe dose of HMPL-A580 and to see if it has any anti-tumor activity. You might be able to join if you are at least 18 years old, have a confirmed solid tumor, and have at least one tumor that can be measured. The study will look at how many participants experience side effects and how many see their tumors shrink or disappear. This study plans to enroll 186 participants.

Study design
This is a first-in-human, open-label study, meaning you and your doctors will know you are receiving HMPL-A580. It will involve two parts: a dose escalation phase (Part A) and a dose expansion/optimization phase (Part B).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects and the maximum tolerated dose for approximately 12 months. Tumor response will be measured for at least 8 weeks up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07396584

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hutchmed
~186 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:HMPL-A580

At a glance

Recruiting sites
1 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
Measured over Approximately 12 months
+3 more outcomes measured
Solid Tumors, Adult

NCT07396584

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • BRCR Global

    Plantation, Floridastudy coordinator listed

    Not yet recruiting

  • Florida Clinical Trials Group LLC (Plantation)

    Plantation, Floridastudy coordinator listed

    Not yet recruiting

  • Florida Clinical Trials Group LLC (Tamarac)

    Tamarac, Floridastudy coordinator listed

    Not yet recruiting

  • Shanghai East Hospital

    Shanghai, Chinastudy coordinator listed

    Recruiting

  • University of California Irvine Medical Center

    Orange, Californiastudy coordinator listed

    Not yet recruiting

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washingtonstudy coordinator listed

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Chinano site contact published

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Chinano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

  • 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-A580Approximately 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.