A Study of Sovilnesib in Subjects With Ovarian Cancer

NCT06084416 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SOVI-2302
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 13

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).

Conditions

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

Keywords

KIF18A Inhibitor

Outcome Measures

Primary Outcomes (6)

• Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib

  Up to 24 months

• Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  Up to 24 months

• Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

  Up to 24 months

• Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

  Up to 24 months

• Frequency of Dose Interruptions and Permanent Treatment Discontinuations

  Up to 24 months

• Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  Up to 24 months

Secondary Outcomes (5)

• Duration of Response (DOR) as assessed by RECIST version 1.1

  Up to 24 months

• Disease Control Rate (DCR) as assessed by RECIST version 1.1

  Up to 24 months

• Progression Free Survival (PFS) as assessed by RECIST version 1.1

  Up to 24 months

• Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria

  Up to 24 months

• Plasma level of Sovilnesib

  Up to 24 months

Study Arms (4)

Dose Level 1

EXPERIMENTAL

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

Drug: Sovilnesib

Dose Level 2

EXPERIMENTAL

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

Drug: Sovilnesib

Dose Level 3

EXPERIMENTAL

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

Drug: Sovilnesib

Dose Level 4

EXPERIMENTAL

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

Drug: Sovilnesib

Interventions

Sovilnesib DRUG

Sovilnesib tablets will be given orally.

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Volastra Therapeutics, Inc.: lead

Study Sites (13)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Georgia Cancer Center Augusta University

Atlanta, Georgia, 30912, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29020, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Chromosomal Instability

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genomic Instability

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: April 4, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (13)