A Study of Sovilnesib in Subjects With Ovarian Cancer

Summary

This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.

Detailed Description

This is a phase 1b study of sovilnesib in subjects with advanced solid tumors. The focus of the proposed clinical study is to establish the optimal dose of sovilnesib for further clinical development. 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 two parts: Part 1 and Part 2. Part 1 is a randomized dose optimization phase in the biomarker-unselected platinum resistant HGSOC patient population. Part 2 is a randomized dose optimization phase in the p16 positive (biomarker-selected) platinum resistant HGSOC patient population. Depending on the emerging data of the Part 1 dose optimization stage, consideration will be given to initiate sub-study cohort(s) in other selected locally advanced or metastatic tumor types to provide additional safety, PK/PD and preliminary efficacy data. 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 Criteria

Interventions