Phase 12a Study Evaluating Safety and Effectiveness of HMPL-A251 in Adults With Advanced or Metastatic HER2-Positive Solid Tumors

What this Trial Is About

Researchers are studying HMPL-A251, a new drug, in adults with advanced or metastatic HER2-expressing solid tumors that cannot be removed by surgery. This phase 12a clinical trial aims to find the highest safe dose and the best dose to use in later studies. The study also explores the safety and preliminary effectiveness of HMPL-A251 in participants who have been previously treated for HER2-positive solid tumors. The study has two parts a Dose Escalation phase and a Dose ExpansionDose Optimization phase. In the Dose Escalation phase, participants receive increasing doses of HMPL-A251 through intravenous infusion to determine the maximum tolerated dose and recommended dose for further study. In the Dose Expansion phase, participants are assigned to one of two selected dose levels to further evaluate safety and effectiveness. Treatment continues until disease progression, intolerable side effects, or other study criteria are met. Participants will undergo regular assessments including monitoring for side effects and treatment response using criteria such as measurable lesions and performance status. Researchers will also collect data on dosing, adverse events, and tumor response over time. The main outcomes include determining safe dosage levels, overall response rate, and treatment-emergent adverse events. Participation may last up to about two years, with ongoing monitoring for safety and treatment effects.

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors