Recruiting
Phase 1

Sovilnesib

Sponsor:

Volastra Therapeutics, Inc.

Code:

NCT06084416

Conditions

High Grade Serous Adenocarcinoma of Ovary

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Chromosomal Instability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sovilnesib

Study Details

Brief 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.

Conditions

High Grade Serous Adenocarcinoma of Ovary

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Chromosomal Instability

Study ID

NCT06084416

Start date

Apr 4, 2024

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Level 1

Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.

experimental: Dose Level 2

Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.

experimental: Dose Level 3

Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.

experimental: Dose Level 4

Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Interventions

Sovilnesib

Sovilnesib tablets will be given orally.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Volastra Therapeutics, Inc.

(646) 344-1248clinicaltrials@volastratx.com

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Charles A. Leath, III, MD

205-934-4986

Georgia Cancer Center Augusta University

Recruiting

Atlanta, Georgia, United States, 30912

Contacts

Gwendolyn Stanley, RN

706-721-3473gstanley@augusta.edu

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

ASK-RPCI

877-245-7724askroswell@roswellpark.org

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Christine Pappaterra

405-271-8707christine-pappaterra@ouhsc.edu

More Information

Sponsor

Volastra Therapeutics, Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • KIF18A Inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Volastra Therapeutics, Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.