NCT06084416

A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Advanced High Grade Serous Ovarian Cancer

Active, enrolled Phase 1 Last updated 15 October 2025

What this trial tests

Phase 1 trial testing Sovilnesib in High Grade Serous Adenocarcinoma of Ovary in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 April 2024

Primary endpoint
1 March 2026

1 April 2026

Quick facts

Lead sponsor	Volastra Therapeutics, Inc.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	4 April 2024
Primary completion	1 March 2026
Estimated completion	1 April 2026
Sites	13 locations across United States

Drugs / interventions tested

• Sovilnesib — full drug profile →

Conditions studied

• High Grade Serous Adenocarcinoma of Ovary — all drugs for High Grade Serous Adenocarcinoma of Ovary →
• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
• Primary Peritoneal Carcinoma — all drugs for Primary Peritoneal Carcinoma →
• Chromosomal Instability — all drugs for Chromosomal Instability →

Sponsor

Volastra Therapeutics, Inc. — full company profile →

Who can join

18 and older, female only, with High Grade Serous Adenocarcinoma of Ovary or Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surviving the Storm: The Role of Poly- and Depolyploidization in Tissues and Tumors.
   Zhao Y, He S, Zhao M, Huang Q. · · 2024 · cited 6× · PMID 38629780 · DOI 10.1002/advs.202306318
2. Epigenetic Regulation of Chromosomal Instability by EZH2 Methyltransferase.
   Bai Y, Agustinus AS, Yomtoubian S, Meydan C, et al · · 2026 · cited 2× · PMID 41036949 · DOI 10.1158/2159-8290.cd-25-0947
3. Loss of JAK1 Function Causes G2-M Cell-Cycle Defects Vulnerable to KIF18A Inhibition.
   Kelley VM, Baro M, Gasperi WE, Ader NR, et al · · 2026 · PMID 41591363 · DOI 10.1158/0008-5472.can-25-1423
4. Small Molecules Identified by an In Silico Docking Screen Targeting Anaphase-Promoting Complex/Cyclosome Subunit 1 (APC1) Potentiate Paclitaxel-Induced Breast Cancer Cell Death.
   Schuyler SC, Gupta R, Nguyen TTB, Weng CY, et al · · 2025 · PMID 40005207 · DOI 10.3390/molecules30040895