This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.
All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
Histologically confirmed locally advanced, inoperable, or metastatic tumor.
High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically confirmed; locally advanced, inoperable or metastatic; p16 positive (Part 2 only); platinum resistant (defined as radiographic progression/recurrence <180 days after last dose of ≥ 4 cycles of platinum containing therapy) or refractory; prior bevacizumab treatment, unless ineligible or intolerant; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor (unless ineligible or intolerant).
Part 1 only: MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
Endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor or mixed tumors containing any of the above histologies
Previously received KIF18A inhibitor
Leptomeningeal disease, or new or progressive CNS metastases or spinal cord compression
Parallel
Sovilnesib
DrugSovilnesib tablets will be given orally.
Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib
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
Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Duration of Response (DOR) as assessed by RECIST version 1.1
Disease Control Rate (DCR) as assessed by RECIST version 1.1
Progression Free Survival (PFS) as assessed by RECIST version 1.1
Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria
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