A Study of Sovilnesib in Subjects with Ovarian Cancer
Gynecologic Cancers
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Male and Female
SOVI-2302 (primary)
NCI-2024-02290
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.
Eligibility
- 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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.