HMPL-A830 in Solid Tumors | NCT07718581

NCT07718581

Overview

NCT ID: NCT07718581
Lead Sponsor: HutchmedINDUSTRY
Official Title: A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
Brief Summary: 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.
Conditions: Solid Tumor, Adult
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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;