A Study of Sovilnesib in Subjects With Ovarian Cancer
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.
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
- Histologically confirmed locally advanced, inoperable, or metastatic tumor.
- High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically confirmed; locally advanced, inoperable or metastatic; p16 positive (Part 2 only); platinum resistant (defined as radiographic progression/recurrence <180 days after last dose of ≥ 4 cycles of platinum containing therapy) or refractory; prior bevacizumab treatment, unless ineligible or intolerant; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor (unless ineligible or intolerant). Key
Exclusion Criteria
- Part 1 only: 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
- Leptomeningeal disease, or new or progressive CNS metastases or spinal cord compression
- Cardiac parameters: MI, PE, CABG, severe/unstable angina or stroke ≤ 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06084416.
Locations matching your search criteria
United States
California
Los Angeles
Maryland
Baltimore
Oklahoma
Oklahoma City
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.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationVolastra Therapeutics, Inc.
- Primary IDSOVI-2302
- Secondary IDsNCI-2024-02290
- ClinicalTrials.gov IDNCT06084416