Trial of THEO-260 in Ovarian Cancer Patients (OCTOPOD)

April 9, 2026 updated by: Theolytics Limited

A Phase I/IIa, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 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 intravenously 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)

44

Phase

  • Phase 2
  • 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

  • Spain
      • Madrid, Spain
        • Recruiting
        • Centro Integral Oncológico Clara Campal (CIOCC) Hospital
        • Principal Investigator:
          • Ramón Yarza
        • Contact:
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust, Hammersmith Hospital
        • Contact:
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
        • Contact:
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • Recruiting
        • The Beatson West of Scotland Cancer Centre
        • 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 disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease (recurrence/ progression during first line platinum treatment) and patients who are intolerant to or have no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator.
  • Life expectancy of > 3 months.
  • ECOG performance status of 0 or 1.
  • Measurable disease as per RECIST V1.1.

Exclusion Criteria:

  • Prior anti-cancer treatment within 28 days or 5 half-lives, prior to first dose of THEO-260.
  • Prior treatment with a group B adenovirus.
  • Currently enrolled in a clinical trial of an IMP or used any IMP with 5 half-live, prior to first dose of THEO-260.
  • Radiation therapy within 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial.
  • 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.
  • 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 the IMP.
  • Viral infection during the 2 weeks prior to first dose of THEO-260.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • Known risk of renal injury, including those with a past history of acute or sub-acute renal disease.
  • Known heart failure New York Heart Association (NYHA) Class 2-4.
  • Known contra-indications or hypersensitivity to the AxMP, paracetamol.
  • Known alcohol consumption in excess of 2 units per day.
  • Left ventricular ejection fraction (LVEF) <50%, 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 28 days prior to first dose of THEO-260.

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 [Part A]
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 [Part A]
Time Frame: Estimated at 2 years
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Estimated at 2 years
Evaluate preliminary efficacy of THEO-260 [Part B]
Time Frame: Estimated at 16 weeks
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Estimated at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of THEO-260
Time Frame: Estimated at 16 weeks
Assess PK parameters of THEO-260
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, measurement by key cytokines/biomarkers in blood.
Until Day 29 after first dose
Preliminary efficacy of THEO-260 [Part A]
Time Frame: Estimated at 16 weeks
Determine tumour response by RECIST v1.1 and iRECIST, changes in CA-125 and patient reported outcomes using EORTC QoL questionnaires
Estimated at 16 weeks
Safety and tolerability of THEO-260 [Part B]
Time Frame: Until end of trial, estimated at 1 year after start of enrolment
Assessment of AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Lab oratory parameters and clinical safety assessments.
Until end of trial, estimated at 1 year after start of enrolment

Collaborators and Investigators

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

Sponsor

Theolytics Limited

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)

September 24, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THEO-260-001

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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