Evaluating Sovilnesib for Ovarian Cancer Treatment
A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects with Advanced High Grade Serous Ovarian Cancer
This study is testing a new drug called sovilnesib to see if it can safely help people with a tough type of ovarian cancer that doesn't respond to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Volastra Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 13 sites (Birmingham, Alabama and 12 other locations) |
| Trial ID | NCT06084416 on ClinicalTrials.gov |
What this trial studies
This phase 1b clinical trial investigates the safety, tolerability, pharmacokinetics, and efficacy of sovilnesib in patients with platinum-resistant high grade serous ovarian cancer. The study employs an adaptive multi-cohort design, where participants are randomized to receive different dose levels of the drug. The trial consists of two parts: the first part involves a small group of subjects to gather preliminary data, while the second part expands the participant pool to refine the recommended dose for future studies. The goal is to establish the optimal dose of sovilnesib for treating this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed high grade serous ovarian cancer who are platinum-resistant.
Not a fit: Patients with certain genetic mutations or those who have previously received KIF18A treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with resistant forms of ovarian cancer.
How similar studies have performed: While this approach is novel in the context of KIF18A inhibition for ovarian cancer, similar studies targeting other pathways have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 12 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- Hoag Memorial Hospital — Newport Beach, California, United States (Recruiting)
- Georgia Cancer Center Augusta University — Atlanta, Georgia, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- MUSC Hollings Cancer Center — Charleston, South Carolina, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Volastra Therapeutics, Inc.
- Email: clinicaltrials@volastratx.com
- Phone: (646) 344-1248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.