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

April 16, 2026 updated by: Theolytics Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Amir Jazaeri
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THEO-260
Biological: THEO-260
Oncolytic virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of THEO-260
Time Frame: Until Day 28 after first dose
Assessment of DLTs and AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Laboratory parameters and clinical safety assessments.
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
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Estimated at 18 months after start of enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) profile of THEO-260
Time Frame: Estimated at 16 weeks
Assess PK profile (maximum concentration - Cmax) of THEO-260 in blood by qPCR
Estimated at 16 weeks
Shedding of THEO-260
Time Frame: Until Day 29 after first dose
Detection of THEO-260 in buccal, urine and faecal samples.
Until Day 29 after first dose
Systemic CRS risk after THEO-260
Time Frame: Until Day 29 after first dose
Incidence and severity of CRS, measured by key cytokines/biomarkers in blood
Until Day 29 after first dose
Evaluate preliminary efficacy of THEO-260
Time Frame: Estimated at 16 weeks
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Estimated at 16 weeks
Pharmacokinetic (PK) profile of THEO-260
Time Frame: Estimated at 16 weeks
Assess PK profile (time to reach maximum concentration - Tmax) of THEO-260 in blood by qPCR
Estimated at 16 weeks
Pharmacokinetic (PK) profile of THEO-260
Time Frame: Estimated at 16 weeks
Assess PK profile (area under the curve - AUC) of THEO-260 in blood by qPCR
Estimated at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theolytics Limited

Investigators

  • Study Director: Clinical Trials, Theolytics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Actual)

October 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THEO-260-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on THEO-260

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe