Study of the Drug Sovilnesib in People with Ovarian Cancer

https://www.facingourrisk.org/research-clinical-trials/study/308/study-of-the-drug-sovilnesib-in-people-with-ovarian-cancer

Clinicaltrials.gov identifier:
NCT06084416 (https://clinicaltrials.gov/show/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]

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.

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, fallopian tube, or primary peritoneal cancer
Have metastatic or inoperable cancer
Have platinum resistance (have recurrent cancer within 6 months after platinum therapy) or platinum-refractory ovarian, fallopian tube or primary peritoneal cancer
Had previously bevacizumab therapy or were not eligible for the treatment
People who have an inherited or acquired BRCA1 or BRCA2 mutation must have previously received a PARP inhibitor or were not eligible for PARP inhibitor 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, dMMR (mismatch repair deficiency), or POLE gene mutation
Have endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor, or mixed tumors containing an MSI-high, dMMR (mismatch repair deficiency), or POLE gene mutation
Previously received a KIF18A inhibitor
Have metastatic 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

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.