A Study of Sovilnesib in Subjects with Ovarian Cancer

Last updated: December 16, 2024
Sponsor: Volastra Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Fallopian Tube Cancer

Pelvic 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:
July 31, 2025

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

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Georgia Cancer Center Augusta University

    Atlanta, Georgia 30912
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10128
    United States

    Active - Recruiting

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73117
    United States

    Active - Recruiting

  • MUSC Hollings Cancer Center

    Charleston, South Carolina 29020
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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