Phase Ib Study of PRJ1-3024 Capsules Taken Orally in Chinese Adults With Unresectable Advanced or Metastatic Melanoma

What this Trial Is About

Researchers are evaluating PRJ1-3024, a new oral drug that inhibits Hematopoietic progenitor kinase 1 HPK-1, in adults with locally advanced or metastatic melanoma that cannot be removed by surgery. This Phase Ib, open-label study in China aims to assess the safety, tolerability, and early effectiveness of this treatment in patients who have already tried at least one standard therapy. The study also focuses on how the drug behaves in the body and its effects on the tumor. Participants will take PRJ1-3024 capsules orally once a day, starting at a dose of 300 mg. The study includes a dose escalation phase with 3 to 6 subjects to find the appropriate dose, followed by one or two dose backfill groups to further evaluate safety and efficacy. The treatment is tested specifically in Chinese patients with advanced melanoma that cannot be surgically removed or has spread. During the study, researchers will monitor tumor response, how long the response lasts, progression-free survival, and disease control rates over 24 months. They will also track pharmacokinetic data and any side effects. Participants must be willing to take the medication daily, attend regular visits, provide tissue samples, and complete assessments. The total observation period for outcomes and safety is 24 months from treatment start.

A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma