Status:
ACTIVE_NOT_RECRUITING
A Study of Sovilnesib in Subjects With Ovarian Cancer
Lead Sponsor:
Volastra Therapeutics, Inc.
Conditions:
High Grade Serous Adenocarcinoma of Ovary
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a randomized, phase 1b dose optimization study of sovilnesib in subjects with platinum-resistant HGSOC. The focus of the proposed clinical study is to establish the RP2D of sovilnesib in HGSOC...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06084416
Start Date
April 4 2024
End Date
April 1 2026
Last Update
October 20 2025
Active Locations (13)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
UCLA
Los Angeles, California, United States, 90095
4
Hoag Memorial Hospital
Newport Beach, California, United States, 92663