Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05287399
Start Date
August 2 2022
End Date
January 17 2025
Last Update
December 18 2025
Active Locations (4)
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1
California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States, 92024
2
California Cancer Associates for Research & Excellence (cCARE)
Fresno, California, United States, 93720
3
California Cancer Associates for Research & Excellence (cCARE)
San Marcos, California, United States, 92069
4
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130