NCT05287399

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, 600 mg and 800 mg BID are planned.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ASC61 200 mg 1	200mg of ASC61 orally once daily for cycles of 28 days
DRUG	ASC61 200 mg 2	200 mg of ASC61 orally twice daily for cycles of 28 days
DRUG	ASC61 300 mg	300 mg of ASC61 orally twice daily for cycles of 28 days
DRUG	ASC61 400 mg	400 mg of ASC61 orally twice daily for cycles of 28 days
DRUG	ASC61 600 mg	600 mg of ASC61 orally twice daily for cycles of 28 days
DRUG	ASC61 800 mg	800 mg of ASC61 orally twice daily for cycles of 28 days

Timeline

• Start date: 2022-08-02
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2022-03-18
• Last updated: 2025-12-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study