Clinicaltrials.gov identifier:
NCT06084416
Treatment
This study will examine the safety and effectiveness of the new treatment called sovilnesib in patients with ovarian cancer
Study Contact Information:
For additional information, please contact:
Volastra Therapeutics, Inc. (646) 344-1248, [email protected]
Study of the Drug Sovilnesib in People with Ovarian Cancer
About the Study
This study will test the safety and effectiveness of the drug sovilnesib in patients with ovarian cancer. The study will be divided into two parts.
Part 1: 10 people will be assigned at random to receive different dose levels of the drug sovilnesib. Sovilnesib is a drug in pill form and is taken by mouth.
Part 2: 20 to 30 people will be assigned at random to receive two or more dose levels of the drug sovilnesib by mouth.
What the Study Involves
People in the study will take sovilnesib orally in 28-day cycles. They will continue to receive the medication until the treatment stops working, causes serious side effects, or they do not wish to continue with the treatment.
Study Sites
California
Newport Beach
Hoag Memorial Hospital
Contact: Patrice Jones at 949-764-5501 or email at [email protected]
Maryland
Baltimore
Johns Hopkins Hospital
Contact Johns Hopkins at 410-614-1361 or email at [email protected]
Massachusetts
Boston
Dana Farber Cancer Institute
Contact Joyce Liu, MD at 877-338-7425
New York
New York
Icahn School of Medicine at Mount Sinai
Contact Neha Kumarley, MPH, CCRC at 212-824-7859 or email at [email protected]
Washington
Seattle
Fred Hutchinson Cancer Center
Contact [email protected]
This study is open to females assigned at birth, aged 18 years and older, who meet the following criteria:
- Can take oral medication
- Have high-grade serous ovarian, , or primary peritoneal cancer
- Have or inoperable cancer
- Have platinum resistance (have recurrent cancer within 6 months after platinum therapy) or platinum-refractory ovarian, or primary peritoneal cancer
- Had previously bevacizumab therapy or were not eligible for the treatment
- Have a hereditary or somatic or gene mutation and previously received a or were not eligible for the treatment.
This study is not open to people who:
- Are under 18 years old
- Male
- Confirmed , (), or POLE gene mutation
- Have endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor, or mixed tumors containing an , (), or POLE gene mutation
- Previously received a KIF18A inhibitor
- Have diseases in the brain or nervous system
- Had myocardial infarction (MI) or stroke within 6 months
- Had unstable angina, pulmonary embolism (arteries in the lungs are blocked by a blood clot), or deep vein thrombosis (formation of a blood clot in a deep vein) within 6 months
- Had coronary artery bypass surgery within 6 months
- Have any gastrointestinal condition that might affect the absorption of oral medications