Recruiting
Phase 1
Phase 2

HMPL-A580

Sponsor:

Hutchmed

Code:

NCT07396584

Conditions

Solid Tumors, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HMPL-A580

HMPL-A580

Study Details

Brief 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.

Conditions

Solid Tumors, Adult

Study ID

NCT07396584

Start date

Mar 4, 2026

Status verified date

Sep, 2026

Completion date

Jan 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

186 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A(Phase I) Dose Escalation

experimental: Part B(Phase IIa) Dose Expansion/Dose Optimization

Interventions

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.

Primary outcome measure

  • Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) [ Time Frame: Approximately 12 months ]
  • Overview of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Approximately 12 months ]
  • Objective Response Rate (ORR) [ Time Frame: 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 ]

Central Contacts and Locations

Locations

BRCR Global

Recruiting

Plantation, Florida, United States, 33324

Contacts

Florida Clinical Trials Group LLC (Plantation)

Recruiting

Plantation, Florida, United States, 33324

Contacts

Florida Clinical Trials Group LLC (Tamarac)

Recruiting

Tamarac, Florida, United States, 33319

Contacts

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

More Information

Sponsor

Hutchmed

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Hutchmed on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.