ACTIVE_NOT_RECRUITING

A Study of Sovilnesib in Subjects With Ovarian Cancer

Conditions

High Grade Serous Adenocarcinoma of Ovary Fallopian Tube Cancer Primary Peritoneal Carcinoma Chromosomal Instability KIF18A Inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).

Official Title

A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Advanced High Grade Serous Ovarian Cancer

Quick Facts

Study Start:2024-04-04

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06084416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

UCLA

Los Angeles, California, 90095

United States

Hoag Memorial Hospital

Newport Beach, California, 92663

United States

Georgia Cancer Center Augusta University

Atlanta, Georgia, 30912

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Corewell Health

Grand Rapids, Michigan, 49503

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10128

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117

United States

MUSC Hollings Cancer Center

Charleston, South Carolina, 29020

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Volastra Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

KIF18A Inhibitor

Additional Relevant MeSH Terms

High Grade Serous Adenocarcinoma of Ovary
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Chromosomal Instability