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โ† Trials
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A Study of Sovilnesib in Subjects With Ovarian Cancer

RecruitingPhase 1Ages 18 Years - anyAllVolastra Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * All Parts: Age โ‰ฅ 18 years, ECOG Performance Status โ‰ค 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 โ‰ฅ 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 โ‰ค 6 months, NYHA Class โ‰ฅ 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
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What it tests

  • Sovilnesib
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Where

11 sites
The University of Alabama at Birmingham
Birmingham, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Hoag Memorial Hospital
Newport Beach, United States
Georgia Cancer Center Augusta University
Atlanta, United States
Johns Hopkins Hospital
Baltimore, United States
Dana Farber Cancer Institute
Boston, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
Icahn School of Medicine at Mount Sinai
New York, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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