A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors
Sponsor: Sapience Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-Limiting Toxicity (DLT)
Time frame: 20 months
Adverse Events
Time frame: 20 months
Secondary Endpoints
Area Under the Curve (AUC)
Cmax
Terminal Half-Life (t1/2)
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria 1. Able and willing to sign informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein. 2. Male or female ≥18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Must have a locally advanced or metastatic inoperable tumor as follows: 1. For the dose escalation/regimen exploration phase: melanoma, carcinoma, or sarcoma 2. For the expansion phase: HR positive LA/MBC, melanoma, GBM, CRPC 5. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Archived biopsies are acceptable for GBM patients. 6. In the invest…
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