A Study of Sovilnesib in Subjects with Ovarian Cancer

Active:	Yes
Cancer Type:	Gynecologic Cancers Primary Peritoneal Cancer Unknown Primary	NCT ID:	NCT06084416
Trial Phases:	Phase I	Protocol IDs:	SOVI-2302 (primary) NCI-2024-02290
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Volastra Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06084416

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).

Objectives

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.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

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