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

NCT05287399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2025-01-17
Completion
2025-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287399 on ClinicalTrials.gov