> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sovilnesib-in-subjects-with-ovarian-cancer-3372821f-c125-41ee-9da2-60db02237993 > Record changed: 2026-11-04 # A Study of Sovilnesib in Subjects With Ovarian Cancer NCT06084416 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Lead sponsor Volastra Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Start date 2024-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Short title** A Study of Sovilnesib in Subjects With Ovarian Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Official title** A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Selected Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **First posted** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Start date** 2024-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Lead sponsor** Volastra Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Identifiers **Registry ID** NCT06084416 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **ClinicalTrials.gov ID** NCT06084416 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Outcomes ### Primary outcomes 1. Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib Timeframe: Up to 24 months 2. 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 Timeframe: Up to 24 months 3. Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0 Timeframe: Up to 24 months 4. Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0 Timeframe: Up to 24 months 5. Frequency of Dose Interruptions and Permanent Treatment Discontinuations Timeframe: Up to 24 months 6. Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Timeframe: Up to 24 months ### Secondary outcomes 1. Duration of Response (DOR) as assessed by RECIST version 1.1 Timeframe: Up to 24 months 2. Disease Control Rate (DCR) as assessed by RECIST version 1.1 Timeframe: Up to 24 months 3. Progression Free Survival (PFS) as assessed by RECIST version 1.1 Timeframe: Up to 24 months 4. Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria Timeframe: Up to 24 months 5. Overall Survival (OS) (Part 2 only) Timeframe: Up to 24 months 6. Plasma level of Sovilnesib Timeframe: Up to 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Sites - The University of Alabama at BirminghamBirmingham, United StatesRecruiting - University of Arkansas for Medical SciencesLittle Rock, United StatesActive, not recruiting - Hoag Memorial HospitalNewport Beach, United StatesActive, not recruiting - Georgia Cancer Center Augusta UniversityAtlanta, United StatesRecruiting - Johns Hopkins HospitalBaltimore, United StatesActive, not recruiting - Dana Farber Cancer InstituteBoston, United StatesActive, not recruiting - Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting - Icahn School of Medicine at Mount SinaiNew York, United StatesActive, not recruiting - OU Health Stephenson Cancer CenterOklahoma City, United StatesRecruiting - MUSC Hollings Cancer CenterCharleston, United StatesActive, not recruiting - Fred Hutchinson Cancer CenterSeattle, United StatesActive, not recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084416) ## Related records ### Drugs (1) - [AMG-650](https://trialight.com/data/asset/amg-650-b8cee8e9-98ef-447b-bd11-8cfcefa504c7.md) ### Lead sponsors (1) - [Volastra Therapeutics, Inc.](https://trialight.com/data/company/volastra-therapeutics-inc-44d0e323-ed97-42be-9519-d4d83252137c.md) ### Conditions (3) - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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