Evaluating Sovilnesib for Ovarian Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* 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).

Key Exclusion Criteria:

* 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
* Cardiac parameters: MI, PE, CABG, severe/unstable angina or stroke ≤ 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 it's running

• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Georgia Cancer Center Augusta University
  Atlanta, Georgia, United States Recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Recruiting
• OU Health Stephenson Cancer Center
  Oklahoma City, Oklahoma, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Active not recruiting
• Hoag Memorial Hospital
  Newport Beach, California, United States Active not recruiting

Study contacts

• Study coordinator: Volastra Therapeutics, Inc.
• Email: clinicaltrials@volastratx.com
• Phone: (646) 344-1248

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.