This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).
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Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib
Timeframe: Up to 24 months
Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Timeframe: Up to 24 months
Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Timeframe: Up to 24 months
Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Timeframe: Up to 24 months
Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Timeframe: Up to 24 months
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Timeframe: Up to 24 months