NCT07396584

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_1

Timeline
33mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
2 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Jan 2029

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 1, 2026

Last Update Submit

March 24, 2026

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (4)

  • Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)

    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)

    To characterize the safety of HMPL-A580 at RDE(s)

    Approximately 12 months

  • Objective Response Rate (ORR)

    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

    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 Outcomes (2)

  • disease control rate (DCR)

    Approximately 2 years

  • progression-free survival (PFS)

    Approximately 2 years

Study Arms (2)

Part A(Phase I) Dose Escalation

EXPERIMENTAL
Drug: HMPL-A580

Part B(Phase IIa) Dose Expansion/Dose Optimization

EXPERIMENTAL
Drug: HMPL-A580

Interventions

HMPL-A580DRUG

Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.

Part A(Phase I) Dose Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understood this study and are able to voluntarily sign the informed consent form (ICF);
  • Male or Female, Age ≥ 18 years;
  • Histological confirmed, unresectable, advanced or metastatic solid tumor
  • Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

You may not qualify if:

  • An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
  • 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
  • Major surgery within 28 days prior to the first dose of study drug
  • Active infection requiring systemic treatment
  • Participant has received a live within 3 months before study enrollment
  • History of inflammatory gastrointestinal diseases
  • Known hypersensitivity to any component of HMPL-A580
  • Pregnant (positive pregnancy test) or lactating;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California Irvine Medical Center

Orange, California, 92868, United States

NOT YET RECRUITING

BRCR Global

Plantation, Florida, 33324, United States

NOT YET RECRUITING

Florida Clinical Trials Group LLC (Plantation)

Plantation, Florida, 33324, United States

NOT YET RECRUITING

Florida Clinical Trials Group LLC (Tamarac)

Tamarac, Florida, 33319, United States

NOT YET RECRUITING

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, China

NOT YET RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 30, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(5)CN(6)