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NCT06084416 | RECRUITING | High Grade Serous Adenocarcinoma of Ovary

A Study of Sovilnesib in Subjects with Ovarian Cancer
Sponsor:

Volastra Therapeutics, Inc.

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).

Condition or disease

High Grade Serous Adenocarcinoma of Ovary

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Chromosomal Instability

Intervention/treatment

Sovilnesib

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects with Advanced High Grade Serous Ovarian Cancer
Actual Study Start Date : 2024-04-04
Estimated Primary Completion Date : 2025-03
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Key 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.
  • Key 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
A Study of Sovilnesib in Subjects with Ovarian Cancer

Location Details

NCT06084416

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

The University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, Arkansa

University of Arkansas for Medical Sciences

Little Rock, Arkansa, United States, 72205

RECRUITING

United States, California

UCLA

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Hoag Memorial Hospital

Newport Beach, California, United States, 92663

RECRUITING

United States, Georgia

Georgia Cancer Center Augusta University

Atlanta, Georgia, United States, 30912

RECRUITING

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Corewell Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10128

RECRUITING

United States, Oklahola

OU Health Stephenson Cancer Center

Ololama City, Okholohan, United States, 73117

RECRUITING

United States, South Carolina

MUSC Hollings Cancer Center

Charleston, South Carolina, United States, 29020

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109