Ovarian CancerPhase 1/2OCTOPODNCT06618235
Trial of THEO-260 in Ovarian Cancer Patients
A Phase 1/2 study testing THEO-260 in people with Ovarian Cancer, run by Theolytics Limited at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- THEO-260
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Sep 2024to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 24Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland
Patricia Roxburgh, +441413017000, patricia.roxburgh2@nhs.scot
- Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London
Jon Krell, +442033131000, jonathankrell@doctors.org.uk
- Recruiting
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford
Sarah Blagden, +44300304777, sarah.blagden@oncology.ox.ac.uk
Spain1 site, 1 recruiting
- Recruiting
Centro Integral Oncológico Clara Campal (CIOCC) Hospital
Madrid
Ramon Yarza, +441865607020, ramon.yarza@startmadrid.com
Ramon Yarza
About this study
Official title: 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.
- Conditions
- Ovarian Cancer
- Being tested
- THEO-260
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THEO-260Biological
Oncolytic Virus
| Study group | Role | What they receive |
|---|---|---|
| THEO-260 | Experimental | Not described Receives: Biological: THEO-260 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of THEO-260 [Part A]
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.
Measured: Until Day 28 after first dose
Establish recommended Phase 2 dose (RP2D) for THEO-260 [Part A]
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Measured: Estimated at 2 years
Evaluate preliminary efficacy of THEO-260 [Part B]
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Measured: Estimated at 16 weeks
Secondary outcomes (5)
Pharmacokinetics (PK) of THEO-260
Assess PK parameters of THEO-260
Measured: Estimated at 16 weeks
Shedding of THEO-260
Detection of THEO-260 in buccal, urine and faecal samples
Measured: Until Day 29 after first dose
Systemic CRS risk after THEO-260
Incidence and severity of CRS, measurement by key cytokines/biomarkers in blood.
Measured: Until Day 29 after first dose
Preliminary efficacy of THEO-260 [Part A]
Determine tumour response by RECIST v1.1 and iRECIST, changes in CA-125 and patient reported outcomes using EORTC QoL questionnaires
Measured: Estimated at 16 weeks
Safety and tolerability of THEO-260 [Part B]
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.
Measured: Until end of trial, estimated at 1 year after start of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Sep 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theolytics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618235
- Sponsor's protocol ID
- THEO-260-001
- Acronym
- OCTOPOD
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06618235
- Acronym / sponsor ID
- OCTOPOD / THEO-260-001
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Theolytics LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THEO-260 | Experimental | Biological: THEO-260 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THEO-260Oncolytic Virus | Biological | THEO-260 |
Primary outcome
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.
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
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.
5 secondary outcomes
Pharmacokinetics (PK) 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
Preliminary efficacy of THEO-260 [Part A]
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing THEO-260 in people with Ovarian Cancer, run by Theolytics Limited at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (+441865607020, clinicaltrials@theolytics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of THEO-260 [Part A] (time frame: Until Day 28 after first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.