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

• Status: Not yet recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gannex Pharma Co., Ltd.
• Collaborator: Ascletis Pharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

• Adults ≥ 18 years of age at the time of screening

• Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• At least one measurable lesion, as defined by RECIST 1.1

Exclusion Criteria:

• Known symptomatic brain metastases requiring steroids

• Known history of another primary solid tumor

• Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs

• Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis

• Gastrointestinal disorders that might affect drug absorption