A Study of Sovilnesib in Subjects with Ovarian Cancer

ID#: NCT06084416

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: April 04, 2024

End Date: July 01, 2025

Contact Information:
Volastra Therapeutics, Inc.
(646) 344-1248
Summary: 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).
Eligibility: 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
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