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

Advanced Solid Tumors Clinical Trial

Official title:
An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors

Clinical Trial 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.

Clinical Trial Description

Except for the first starting dose of 200 mg once daily (QD), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. Each subject in each dose cohort will use 2 dose schedules: single dose on Day 1 (D1), and repeated doses on daily basis for 28 days starting from Day 3. One treatment cycle is 28 days. Subjects will be sequentially enrolled in a dose-escalation design to receive ASC61 at initial dose of 200 mg QD. Subsequent doses of 200 mg twice a day (BID), 300 mg BID, 400 mg BID, and 600 mg BID are planned. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05287399
Study type Interventional
Source Gannex Pharma Co., Ltd.
Contact Ascletis Study Doctor
Phone +86 571 85389730
Email clinicaltrials@ascletis.com
Status Recruiting
Phase Phase 1
Start date August 2, 2022
Completion date December 20, 2024
View Details
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