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Recruiting NCT07211659

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

Phase I Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: THEO-260.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer

Overview

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.

Interventions

  • Biological THEO-260
    Oncolytic virus

Primary outcome measures

  • Safety and tolerability of THEO-260 [Time frame: Until Day 28 after first dose]
  • Establish recommended Phase 2 dose (RP2D) for THEO-260 [Time frame: Estimated at 18 months after start of enrolment]
Secondary outcome measures (6)
  • Pharmacokinetic (PK) profile of THEO-260 [Time frame: Estimated at 16 weeks]
  • Shedding of THEO-260 [Time frame: Until Day 29 after first dose]
  • Systemic CRS risk after THEO-260 [Time frame: Until Day 29 after first dose]
  • Evaluate preliminary efficacy of THEO-260 [Time frame: Estimated at 16 weeks]
  • Pharmacokinetic (PK) profile of THEO-260 [Time frame: Estimated at 16 weeks]
  • Pharmacokinetic (PK) profile of THEO-260 [Time frame: Estimated at 16 weeks]

Eligibility criteria

  • Inclusion Criteria:
  • Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary either on archival biopsy or fresh tumour biopsy.
  • Platinum-resistant or refractory disease: platinum-resistance is defined as radiological progression within 6 months of last cycle of platinum treatment; platinum refractory disease is defined as radiological progression during the 3 months following the first dose with platinum treatment.
  • Life expectancy of > 6 months.
  • ECOG performance status of 0 or 1.
  • Measurable disease as per RECIST V1.1.
  • No clinical history of bowel obstruction in past 3 months or no clinical signs or symptoms of bowel obstruction.

Exclusion criteria

  • Prior anti-cancer treatment or Investigational Product within 28 days or 5 half-lives, prior to first dose of THEO-260.
  • Prior treatment with a group B adenovirus.
  • Radiation therapy within 4 weeks of first dose of THEO-260
  • Clinical evidence of cerebral metastases or Central Nervous System (CNS) involvement including leptomeningeal disease. Patients with previous cerebral metastases must have no evidence of progression or haemorrhage after treatment.
  • Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
  • Prior pneumonitis or history of interstitial lung disease.
  • Confirmed QTcF ≥470 ms on screening 12-lead ECG or history of Torsades de Pointes or history of congenital long QT syndrome.
  • Concomitant medications that prolong the QTc interval and/or increase the risk for Torsades de Pointes.
  • Patients with active hepatitis infection or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection are eligible.
  • Active infection with tuberculosis.
  • Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2).
  • Patients with active human immunodeficiency virus (HIV) infection or known history of HIV infection.
  • Active infection requiring IV antibiotics within 2 weeks prior to first dose of THEO-260, or long-term oral therapy for systemic infection.
  • Known contra-indications or hypersensitivity to the excipients of THEO-260.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • Known heart failure New York Heart Association (NYHA) Class 2-4.
  • Known contra-indications or hypersensitivity to acetominophen.
  • Known alcohol consumption in excess of 2 units per day.
  • Left ventricular ejection fraction (LVEF) <45%, unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to trial enrolment or a history of myocarditis.
  • Arterial oxygen saturation <92% on room air prior to first dose of THEO-260.
  • Received any licensed or investigational vaccines within 30 days prior to Day 1

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT07211659 · THEO-260-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗