Phase 1 Ovarian Cancer Trial, Recruiting NCT07211659 Sponsor: Theolytics Limited Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT07211659
Recruiting Phase 1

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 have been diagnosed (confirmed by tissue testing) with an advanced form of high-grade ovarian, fallopian tube, or primary peritoneal cancer (specifically serous or endometrioid type), based on either a previous or new biopsy.
  • Your cancer has stopped responding to platinum-based chemotherapy — either it came back or grew within 6 months of finishing treatment, or it continued to grow within the first 3 months of starting platinum treatment.
  • Your doctors expect you to live for more than 6 months.
  • You are generally well enough to carry out light activity and care for yourself (this is measured on a standard medical scale called ECOG, at level 0 or 1).
  • Your cancer can be measured on scans using a standard method called RECIST v1.1.
  • You have not had a bowel blockage in the past 3 months, and you have no current signs or symptoms of one.

Who may not be able to join:

  • You have received any cancer treatment or experimental drug within the past 28 days (or within 5 half-lives of the drug), before starting this trial.
  • You have previously been treated with a type of virus-based therapy called a group B adenovirus.
  • You have had radiotherapy within the 4 weeks before starting the trial.
  • You have cancer that has spread to the brain or nervous system, or you show signs of this; if you previously had brain metastases, there must be no sign of them worsening or bleeding after treatment.
  • You have uncontrolled fluid build-up around the lungs or heart that needs draining at least once a month.
  • You have previously had inflammation of the lungs (pneumonitis) or a chronic lung scarring condition (interstitial lung disease).
  • You have a specific heart rhythm abnormality shown on a heart tracing (ECG), or a personal history of certain inherited or acquired heart rhythm conditions (confirm with trial site).
  • You are currently taking medications known to affect heart rhythm in a way that could be dangerous (confirm with trial site).
  • You currently have an active hepatitis C infection, or an active hepatitis B infection (people with past or resolved hepatitis B may still be eligible).
  • You currently have an active tuberculosis (TB) infection.
  • You currently have an active COVID-19 infection.
  • You have an active HIV infection or a known history of HIV.
  • You have had a serious infection requiring intravenous (IV) antibiotics within the past 2 weeks, or you are on long-term antibiotic tablets for an ongoing infection.
  • You are known to be allergic or sensitive to any ingredients in the trial drug, THEO-260.
  • You have an active autoimmune disease (where your immune system attacks your own body) that has needed treatment in the past 2 years.
  • You have been diagnosed with moderate to severe heart failure (NYHA Class 2–4).
  • You are known to be allergic or sensitive to paracetamol (acetaminophen).
  • You regularly drink more than 2 units of alcohol per day.
  • You have a weakened heart pump (below 45% efficiency), unstable chest pain, a serious uncontrolled heart rhythm problem, a heart attack within the past 6 months, or a history of heart muscle inflammation (myocarditis).
  • Your blood oxygen level is below 92% while breathing normal room air before starting the trial.
  • You have received any vaccine (approved or experimental) within the 30 days before the trial start date.

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 28 July 2026
Phase 1: approximately ~10% 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

Principal Investigator: Clinical Trials, Theolytics Ltd

Phone: +441865607020

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 1
Sponsor
Theolytics Limited
Registry
ClinicalTrials.gov
Start date
13 February 2026
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability of THEO-260; Establish recommended Phase 2 dose (RP2D) for THEO-260

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: 28 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