Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT07211659

Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients

Led by Theolytics Limited · Updated on 2026-04-22

18

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.

CONDITIONS

Official Title

Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum, or ovary on biopsy
  • Platinum-resistant or refractory disease as defined by progression timelines
  • Life expectancy greater than 6 months
  • ECOG performance status of 0 or 1
  • Measurable disease by RECIST V1.1 criteria
  • No clinical history or signs of bowel obstruction in the past 3 months
Not Eligible

You will not qualify if you...

  • Prior anti-cancer treatment or investigational product within 28 days or 5 half-lives before first dose of THEO-260
  • Previous treatment with group B adenovirus
  • Radiation therapy within 4 weeks before first dose
  • Evidence of cerebral metastases or CNS involvement except stable treated metastases
  • Uncontrolled pleural or pericardial effusion requiring frequent drainage
  • History of pneumonitis or interstitial lung disease
  • QTcF 470 ms or greater on ECG, history of Torsades de Pointes or congenital long QT syndrome
  • Medications that prolong QTc interval or increase Torsades risk
  • Active hepatitis infection or hepatitis C; resolved hepatitis B allowed
  • Active tuberculosis infection
  • Active SARS-CoV-2 infection
  • Active or history of HIV infection
  • Active infection requiring IV antibiotics within 2 weeks or long-term oral antibiotics
  • Known hypersensitivity to THEO-260 excipients
  • Active autoimmune disease treated systemically within past 2 years
  • NYHA Class 2-4 heart failure
  • Known hypersensitivity to acetaminophen
  • Alcohol use over 2 units per day
  • LVEF less than 45%, unstable angina, serious arrhythmia, recent myocardial infarction, or myocarditis
  • Arterial oxygen saturation below 92% on room air
  • Receipt of any licensed or investigational vaccine within 30 days before Day 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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