Phase 12a Study of JAB-8263 to Evaluate Safety and Early Effectiveness in Adults With Advanced Solid and Blood Cancers

What this Trial Is About

Researchers are evaluating JAB-8263, a small-molecule inhibitor targeting BET proteins, in adult patients with advanced malignant solid and hematologic tumors in this Phase 12a open-label study. The study aims to find the highest safe dose, assess dose-limiting toxicities, evaluate safety and tolerability, and gather early evidence of antitumor activity in patients whose tumors have progressed despite standard treatments or lack standard options. The study has two parts dose escalation and dose expansion, each enrolling about 30 subjects. Participants receive JAB-8263 orally every two days in 28-day cycles, with dose adjustments to determine the recommended Phase 2 dose. The study monitors how the drug behaves in the body and its preliminary effects on tumors. Participants will undergo evaluations over approximately 18 months, including safety assessments, pharmacokinetic measurements, and tumor response evaluations using standardized criteria. Researchers will record adverse events, response rates, and survival outcomes while monitoring dose-related toxicities. The study does not use randomization or masking, and participants are closely followed to assess treatment effects and safety.

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors