A Study of Sovilnesib in Subjects With Ovarian Cancer
High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
About this trial
This is an interventional treatment trial for High Grade Serous Adenocarcinoma of Ovary focused on measuring KIF18A Inhibitor
Eligibility Criteria
Key Inclusion Criteria: 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 High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically or cytologically confirmed; metastatic or unresectable; platinum resistant (defined as recurrence within 6 months of platinum containing therapy) or platinum refractory; prior bevacizumab treatment, or ineligible or intolerant to bevacizumab, or did not receive bevacizumab based on Investigator judgement; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor or ineligible or intolerant. Key Exclusion Criteria: 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 Current CNS metastases or leptomeningeal disease Cardiac parameters: MI or stroke ≤ 6 months, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF < 50% Any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Level 1
Dose Level 2
Dose Level 3
Dose Level 4
Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.
Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.
Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.
Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.