A Study of Sovilnesib in Subjects with Ovarian 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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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

A Study of Sovilnesib in Subjects with Ovarian Cancer

Condition
High Grade Serous Adenocarcinoma of Ovary
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Newport Beach

Hoag Memorial Hospital, Newport Beach, California, United States, 92663

Atlanta

Georgia Cancer Center Augusta University, Atlanta, Georgia, United States, 30912

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Grand Rapids

Corewell Health, Grand Rapids, Michigan, United States, 49503

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10128

Oklahoma City

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73117

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Volastra Therapeutics, Inc.,

Study Record Dates

2025-07