Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05287399
- Run by
- Ascletis Pharmaceuticals Co., Ltd.
- People needed
- 18
- Starts
- 2022-08-02
- Expected to finish
- 2025-01-17
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- California Cancer Associates for Research & Excellence (cCARE) — Encinitas, California, United States
- California Cancer Associates for Research & Excellence (cCARE) — Fresno, California, United States
- California Cancer Associates for Research & Excellence (cCARE) — San Marcos, California, United States
- Nebraska Cancer Specialists — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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