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Not yet recruiting NCT07718581

HMPL-A830 in Solid Tumors

Phase I / Phase II Interventional Solid Tumor, 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-A830, HMPL-A830.
Who it may be relevant to
Registry conditions: Solid Tumor, 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors

Overview

This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors\*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts: Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled. Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.

Detailed description

Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.

Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors

Interventions

  • Drug HMPL-A830
    Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
  • Drug HMPL-A830
    Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

Primary outcome measures

  • DLTs [Time frame: Approximately 12 months]
  • Overview of Treatment-emergent Adverse Events (TEAEs) [Time frame: Approximately 12 months]
  • Objective Response Rate (ORR) [Time frame: Approximately 24 months]
  • Recommended doses for phase II or III studies (RP2D or RP3D) [Time frame: Approximately 12 months]
Secondary outcome measures (8)
  • Disease control rate (DCR) [Time frame: Approximately 2 years]
  • Progression-free survival (PFS) [Time frame: Approximately 2 years]
  • Pharmacokinetic Analysis(Cmax) [Time frame: Approximately 2 years]
  • Pharmacokinetic Analysis (Cmin) [Time frame: Approximately 2 years]
  • Pharmacokinetic Analysis(Tmax) [Time frame: Approximately 2 years]
  • Pharmacokinetic Analysis((AUClast) [Time frame: Approximately 2 years]
  • Pharmacokinetic Analysis((AUCtau) [Time frame: Approximately 2 years]
  • Incidence of anti-drug antibodies (ADAs) against HMPL-A830 [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

  • 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
  • History of inflammatory gastrointestinal diseases
  • Known hypersensitivity to any component of HMPL-A830
  • 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 · 7 centers
  • Beijing Cancer Hospital — Beijing
  • Hunan Cancer Hospital — Changsha
  • West China Hospital of Sichuan University — Chengdu
  • The Sixth Affiliated Hospital,Sun Yat-sen University — Guangzhou
  • Shandong Cancer Hospital — Jinan
  • Jiangsu Province Hospital — Nanjing
  • Shanxi Provincial Cancer Hospitial — Taiyuan

Identifiers

NCT: NCT07718581 · 2026-830-GLOB1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗