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
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.
• 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 organ function (bone marrow, hepatic, renal function and coagulation).
• All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.