Phase 2 Ovarian Cancer Trial, Recruiting NCT05902988 Sponsor: Volastra Therapeutics, Inc. Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT05902988
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You are able to carry out everyday activities with little or no limitation from your illness (confirm with trial site for exact definition)
  • You have at least one area of cancer that can be measured on a CT scan or MRI
  • You are able to swallow and digest oral (by mouth) medication normally
  • For the dose-finding part of the trial: You have one of the following cancer types and have run out of standard treatment options: high grade serous ovarian cancer, squamous non-small cell lung cancer, triple negative breast cancer, gastric adenocarcinoma (not EBV+), colorectal cancer, esophageal squamous cell carcinoma, esophageal adenocarcinoma, gastroesophageal junction cancer, bladder cancer (transitional cell), certain head and neck squamous cell carcinomas, ovarian carcinosarcoma, or certain endometrial/uterine cancers
  • For the dose-expansion part of the trial: You have one of the similar cancer types listed above and have already received several rounds of standard treatments as specified by the trial

Who may not be able to join:

  • Your cancer has certain specific genetic features (MSI-H, dMMR, POLE mutation, or high mutation rate) — confirm with trial site if unsure
  • You have previously been treated with a type of drug called a KIF18A inhibitor
  • You currently have cancer that has spread to your brain or the lining around your brain or spinal cord
  • You have had a heart attack or stroke within the last year, or certain other heart or blood vessel problems within the last 6 months, or you have significant heart function issues (confirm with trial site for exact details)
  • You are unable to avoid certain medicines that interfere with how the study drug is processed in your body (confirm with trial site for specific medicines)
  • You have significant fluid build-up in your abdomen or around your lungs at the time of joining, or you have had a procedure to drain such fluid within the last 28 days
  • You have had a bowel blockage or a hole in your digestive tract within the last 6 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: (646) 344-1248

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Volastra Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
18 October 2023
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects; Dose Escalation: Determination of the MTD of VLS-1488; Dose Escalation: Frequency of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0; Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0; Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0; Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Dis...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov