NCT06084416 · Volastra Therapeutics, Inc.
A Study of Sovilnesib in Subjects With Ovarian Cancer
What this study is about
This is a phase 1b study to assess the safety, tolerability, how the drug moves through the body (PK), and preliminary effectiveness of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.
View original scientific description
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.
Interventions
DRUG
Sovilnesib
Sovilnesib tablets will be given orally.
Primary outcome measures
Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib
Time frame: Up to 24 months
Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time frame: Up to 24 months
Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Time frame: Up to 24 months
Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Time frame: Up to 24 months
Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Time frame: Up to 24 months
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 24 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Newport Beach, California
- Atlanta, Georgia
- Baltimore, Maryland
- Boston, Massachusetts
- Buffalo, New York
- New York, New York
- Oklahoma City, Oklahoma
- Charleston, South Carolina
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations