HMPL-A830 in Solid Tumors
Sponsor: Hutchmed
ClinicalTrials ID:NCT07718581
This FIH, multicenter, open-label study of HMPL-A830 involves dose escalation and optimization in advanced solid tumors. Part A assesses safety and MTD/RDO in 57 participants, while Part B evaluates safety and efficacy at RDOs in 90 participants. Eligible adults must have measurable lesions, ECOG 0-1, and a life expectancy ≥12 weeks. Participants receive HMPL-A830 at predefined or randomized RDO levels.
Patient Parameters
| Parameter | Options |
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Program 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.
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
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;
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Irvine Medical Center | 92868 | Orange | California |
| BRCR Global | 33065 | Coral Springs | Florida |
| Florida Clinical Trials Group | 33322 | Plantation | Florida |
| START New Jersey | 08816 | East Brunswick | New Jersey |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| START Mountain Region | 84119 | West Valley City | Utah |
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