NCT06727630

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

A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhuhai Yufan Biotechnologies Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma

Detailed description

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma. PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	PRJ1-3024	PRJ1-3024 is provided as capsules and is administered orally once a day

Timeline

• Start date: 2024-03-14
• Primary completion: 2025-04-30
• Completion: 2025-10-30
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China