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A Study of Sovilnesib in Subjects With Ovarian Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Mar 2026 → Nov 2027
See other at-risk trials from Volastra Therapeutics, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2026 to Nov 2027 Show 7 more changesShow less
    • Enrollment reopened
    • Enrollment increased: 120 → 150 participants
    • Study completion pushed from Apr 2026 to Dec 2027
    • Study sites: 13 to 11
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 9 words
  2. Primary completion date: Mar 2025 to Mar 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2025 to Apr 2026
    • Site details revised at 13 of 13 sites
    v11
  3. Study sites: 12 to 13v10
  4. Study sites: 9 to 12v9
  5. Study sites: 6 to 9v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 6v7
  2. Study sites: 4 to 5v6
  3. Study sites: 3 to 4v5
  4. Study sites: 1 to 3v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2024 to Apr 4, 2024
    v3
  6. Study title shortened, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06084416
Lead Sponsor Volastra Therapeutics, Inc.
Conditions
(from sponsor)		 High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Chromosomal Instability
Related terms Chromosomal Instability, Fallopian Tube Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov