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Clinical trial

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

ID
Name
ASC61-101
Description
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.
Trial arms
Trial start
2022-08-02
Estimated PCD
2024-12-20
Trial end
2024-12-20
Status
Recruiting
Phase
Early phase I
Treatment
ASC61 200 mg 1
200mg of ASC61 orally once daily for cycles of 28 days
Arms:
ASC61 200 mg 1
ASC61 200 mg 2
200 mg of ASC61 orally twice daily for cycles of 28 days
Arms:
ASC61 200 mg 2
ASC61 300 mg
300 mg of ASC61 orally twice daily for cycles of 28 days
Arms:
ASC61 300 mg
ASC61 400 mg
400 mg of ASC61 orally twice daily for cycles of 28 days
Arms:
ASC61 400 mg
ASC61 600 mg
600 mg of ASC61 orally twice daily for cycles of 28 days
Arms:
ASC61 600 mg
Size
16
Primary endpoint
Proportion of patients who experience DLTs
From baseline to 28 days of treatment
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
From first dose of ASC61 (Day 1) until 90 days after the last dose
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}
Updated at
2024-04-03

1 organization

1 product

1 indication

Organization
Gannex Pharma
Product
ASC61
Indication
Cancer