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
Step Pharma, SAS
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Advanced disease not curable by available therapies and requires systemic therapy. * Histologically confirmed diagnosis of eligible cancer type. * Must have tumor tissue available for biomarker testing. * Measurable disease (Part 1) and measurable disease per RECIST (Part2) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Life expectancy \> 3 months as assessed by the Investigator. * Adequate…
Interventions
- DrugSTP938
Small molecule
Locations (7)
- Comprehensive Hematology Oncology, LLCSt. Petersburg, Florida
- Mary Crowley Cancer Research CenterDallas, Texas
- Next OncologySan Antonio, Texas
- Institut Gustave RoussyVillejuif, Paris
- The Beatson Institute for Cancer ResearchGlasgow, Glasgow
- University College LondonLondon