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Study of the Drug Sovilnesib in People with Ovarian Cancer

Clinicaltrials.gov identifier:
NCT06084416

Treatment
Treatment study for people with platinum-resistant 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.

Alabama

City: Birmingham RECRUITING
Facility: The University of Alabama at Birmingham
Contact Info:
(205) 934-4986

Arkansas

City: Little Rock RECRUITING
Facility: University of Arkansas for Medical Sciences
Contact Info:
[email protected] 501-686-8274
[email protected]

California

City: Los Angeles RECRUITING
Facility: UCLA
Contact Info:
[email protected] 310-562-8933

City: Newport Beach RECRUITING
Facility: Hoag Memorial Hospital
Contact Info:
[email protected] 9497645501

Georgia

City: Atlanta RECRUITING
Facility: Georgia Cancer Center Augusta University
Contact Info:
[email protected] 706-721-3473

Massachusetts

City: Boston RECRUITING
Facility: Dana Farber Cancer Institute
Contact Info:
877-338-7425

Maryland

City: Baltimore RECRUITING
Facility: Johns Hopkins Hospital
Contact Info:
[email protected] 410-614-1361

Michigan

City: Grand Rapids RECRUITING
Facility: Corewell Health
Contact Info:
[email protected] 616-486-0358

New York

City: Buffalo RECRUITING
Facility: Roswell Park Comprehensive Cancer Center
Contact Info:
[email protected] 1-877-245-7724

City: New York RECRUITING
Facility: Icahn School of Medicine at Mount Sinai
Contact Info:
[email protected] 212-824-7859

Oklahoma

City: Oklahoma City RECRUITING
Facility: OU Health Stephenson Cancer Center
Contact Info:
[email protected] 405-271-8707

South Carolina

City: Charleston RECRUITING
Facility: MUSC Hollings Cancer Center
Contact Info:
[email protected] 843-792-9300
843-792-9300

Washington

City: Seattle RECRUITING
Facility: Fred Hutchinson Cancer Center
Contact Info:
[email protected]

This Study is Open To:

This study is open to females assigned at birth, aged 18 years and older, who meet the following criteria:

  • 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
  • People who have an inherited or acquired  or  mutation must have previously received a or were not eligible for  treatment
This Study is Not Open To:

This study is not open to people who:

  • Are under 18 years old
  • Male
  • Have any of the following biomarkers in their tumor: MSI-H, (), 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