A Study of Sovilnesib in Subjects With Ovarian Cancer

Last updated: October 15, 2025
Sponsor: Volastra Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Pelvic Cancer

Fallopian Tube Cancer

Treatment

Sovilnesib

Clinical Study ID

NCT06084416
SOVI-2302
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site ofmeasurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oralmedication without alteration

  • High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer -histologically or cytologically confirmed; metastatic or unresectable; platinumresistant (defined as recurrence within 6 months of platinum containing therapy) orplatinum refractory; prior bevacizumab treatment, or ineligible or intolerant tobevacizumab, or did not receive bevacizumab based on Investigator judgement; ifgermline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor orineligible or intolerant.

Exclusion

Key Exclusion Criteria:

  • MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype

  • Endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumoror 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 includingthe study drug

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Sovilnesib
Phase: 1
Study Start date:
April 04, 2024
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • The University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Site Not Available

  • UCLA

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Hoag Memorial Hospital

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Georgia Cancer Center Augusta University

    Atlanta, Georgia 30912
    United States

    Site Not Available

  • Georgia Cancer Center Augusta University

    Atlanta 4180439, Georgia 4197000 30912
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10128
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10128
    United States

    Site Not Available

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73117
    United States

    Site Not Available

  • OU Health Stephenson Cancer Center

    Oklahoma City 4544349, Oklahoma 4544379 73117
    United States

    Site Not Available

  • MUSC Hollings Cancer Center

    Charleston, South Carolina 29020
    United States

    Site Not Available

  • MUSC Hollings Cancer Center

    Charleston 4574324, South Carolina 4597040 29020
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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