A Study of Sovilnesib in Subjects With Ovarian Cancer

NCT ID: NCT06084416

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2026-04-30

Brief Summary

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).

Detailed Description

This is a randomized, phase 1b dose optimization study of sovilnesib in subjects with platinum-resistant HGSOC. The focus of the proposed clinical study is to establish the RP2D of sovilnesib in HGSOC.

An adaptive multi-cohort design will be used to assess the safety, tolerability, PK, and efficacy of multiple dose levels in parallel to establish the RP2D of sovilnesib. The study will be conducted in 2 parts.

Part 1: 10 subjects will be randomized to each of the open dose levels to generate preliminary PK, pharmacodynamic (PD), safety, tolerability and efficacy data. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design will be applied.

Part 2: Based on review of the data from Part 1, 20-30 additional subjects will be randomized to 2 or more dose levels examined in Part 1. At the end of Part 2, PK, PD, safety, tolerability and efficacy data will be used to determine the RP2D. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design and for futility based on a Bayesian Efficacy Monitoring via Predictive Probability Design will be applied.

Sovilnesib will be given orally in 28-day cycles at selected dose levels of interest. Dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level 1

Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.

Group Type: EXPERIMENTAL

Sovilnesib

Intervention Type: DRUG

Sovilnesib tablets will be given orally.

Dose Level 2

Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.

Group Type: EXPERIMENTAL

Sovilnesib

Intervention Type: DRUG

Sovilnesib tablets will be given orally.

Dose Level 3

Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.

Group Type: EXPERIMENTAL

Sovilnesib

Intervention Type: DRUG

Sovilnesib tablets will be given orally.

Dose Level 4

Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Group Type: EXPERIMENTAL

Sovilnesib

Intervention Type: DRUG

Sovilnesib tablets will be given orally.

Interventions

Sovilnesib

Sovilnesib tablets will be given orally.

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Volastra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UCLA

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Georgia Cancer Center Augusta University

Atlanta, Georgia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

MUSC Hollings Cancer Center

Charleston, South Carolina, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

SOVI-2302

Identifier Type: -

Identifier Source: org_study_id