HMPL-A830 in Solid Tumors
ConditionSolid Tumor, Adult
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
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.
Eligibility criteria
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
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
Trial design
Treatments tested in this trial
- HMPL-A830
- HMPL-A830
Treatment groups
147 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov