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NCT Number: NCT07718581

HMPL-A830 in Solid Tumors

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HMPL-A830

Drug

Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6

predefined dose levels

Primary outcomes

  1. DLTs

    Time frame: Approximately 12 months

    Number of Participants With of DLTs

  2. Overview of Treatment-emergent Adverse Events (TEAEs)

    Time frame: Approximately 12 months

    The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0

  3. Objective Response Rate (ORR)

    Time frame: Approximately 24 months

    Assessed by investigators according to RECIST 1.1

  4. Recommended doses for phase II or III studies (RP2D or RP3D)

    Time frame: Approximately 12 months

    The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Approximately 2 years

    The DCR by RECIST 1.1

  2. Progression-free survival (PFS)

    Time frame: Approximately 2 years

    The time from the first dose of study drug to the date of first radiographic PD per RECIST v1.1 or death due to any cause, whichever occurs first.

  3. Pharmacokinetic Analysis(Cmax)

    Time frame: Approximately 2 years

    Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)

  4. Pharmacokinetic Analysis (Cmin)

    Time frame: Approximately 2 years

    Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)

  5. Pharmacokinetic Analysis(Tmax)

    Time frame: Approximately 2 years

    Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)

  6. Pharmacokinetic Analysis((AUClast)

    Time frame: Approximately 2 years

    Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)

  7. Pharmacokinetic Analysis((AUCtau)

    Time frame: Approximately 2 years

    Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)

  8. Incidence of anti-drug antibodies (ADAs) against HMPL-A830

    Time frame: Approximately 2 years

    Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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