drugset
drugset / Trial / NCT05287399

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors

NCT05287399 ↗

Phase 1 Completed 18 enrolled Ascletis Pharmaceuticals Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.

Timeline

Start
2022-08-02
Primary completion
2025-01-17
Completion
2025-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject ASC61 Small molecule 200 mg Oral
Subject ASC61 Small molecule 300 mg Oral
Subject ASC61 Small molecule 400 mg Oral
Subject ASC61 Small molecule 600 mg Oral
Subject ASC61 Small molecule 800 mg Oral

Indications

cancer