An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects With Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
Summary
The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.
Arms & interventions
- DrugSTP938
Small molecule
Outcome measures
Primary
Safety and Tolerability
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 6 months
Secondary
Area under the curve (AUC) of STP938
Time frame: 9 days
Maximum plasma concentration (Cmax)
Time frame: 9 Days
Time to reach maximum concentration (TMax)
Time frame: 9 Days
Evaluation of preliminary clinical activity of STP938
Time frame: Through study completion, an average of 6 months
Evaluation of best overall response of STP938
Time frame: Through study completion, an average of 6 months
Evaluation of Duration of Response
Time frame: Through study completion, an average of 6 months
Evaluation of Progression Free Survival
Time frame: Through study completion, an average of 6 months
Change in serum CA125 (ovarian cancer only)
Time frame: Through study completion, an average of 6 months
Eligibility criteria
Study locations (3)
Comprehensive Hematology Oncology, LLC
St. Petersburg, Florida, 33709
Mary Crowley Cancer Research Center
Dallas, Texas, 75251
Next Oncology
San Antonio, Texas, 78292