Health TrialsbyHealthPanel

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • HMPL-A580

    Drug

    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

    Drug

    Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Part A(Phase I) Dose EscalationExperimental treatment 1 intervention
Group B: Part B(Phase IIa) Dose Expansion/Dose OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Approximately 12 months
2

Overview of Treatment-emergent Adverse Events (TEAEs)

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

Time frame
Approximately 12 months
3

Objective Response Rate (ORR)

To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)

Time frame
At least 8 weeks post dose of first participant up to approximately 24 months
4

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.

Time frame
Approximately 12 months

Secondary outcomes

1

disease control rate (DCR)

To assess the preliminary efficacy of HMPL-A580 in solid tumors

Time frame
Approximately 2 years
2

progression-free survival (PFS)

To assess the preliminary antitumor activity of HMPL-A580 in selected solid tumors

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hutchmed

Lead sponsor

Source ClinicalTrials.gov
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