A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Selected Advanced Solid Tumors
Volastra Therapeutics, Inc.
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.
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 phas…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * 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 containin…
Interventions
- DrugSovilnesib
Sovilnesib tablets will be given orally.
Locations (11)
- The University of Alabama at BirminghamBirmingham, Alabama
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Hoag Memorial HospitalNewport Beach, California
- Georgia Cancer Center Augusta UniversityAtlanta, Georgia
- Johns Hopkins HospitalBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts