A Study of Sovilnesib in Subjects with Ovarian Cancer

Launched by VOLASTRA THERAPEUTICS, INC. · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called sovilnesib to see how safe it is and how well it works for women with advanced ovarian cancer, specifically a type called high-grade serous adenocarcinoma. The trial aims to find the best dose of sovilnesib that can be given to patients. To participate, women must be at least 18 years old and have measurable disease confirmed by imaging tests. They should also have specific types of ovarian or related cancers that are either not responding to standard treatments or have returned after treatment.

Participants in this trial will receive sovilnesib in different doses and will be monitored for any side effects and how their cancer responds to the treatment. It's important to know that some women may not be eligible if they have certain other health conditions or types of tumors. This study is currently recruiting participants, and it offers a chance to be part of research that could help improve treatment options for ovarian cancer.

Gender

FEMALE

Eligibility 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