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Recruiting NCT07396584

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

Phase I / Phase II Interventional Solid Tumors, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HMPL-A580, HMPL-A580.
Who it may be relevant to
Registry conditions: Solid Tumors, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • disease control rate (DCR) [Time frame: Approximately 2 years]
  • progression-free survival (PFS) [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Hunan Cancer Hospital — Changsha
  • Guangxi Medical University Cancer Hospital — Nanning
  • Shanghai East Hospital — Shanghai
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Henan Cancer Hospital — Zhengzhou
United States · 5 centers
  • University of California Irvine Medical Center — Orange
  • BRCR Global — Plantation
  • Florida Clinical Trials Group LLC (Plantation) — Plantation
  • Florida Clinical Trials Group LLC (Tamarac) — Tamarac
  • University of Washington/Fred Hutchinson Cancer Center — Seattle

Identifiers

NCT: NCT07396584 · 2025-580-GLOB1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗