Ovarian CancerPhase 1OCTOPOD-IPNCT07211659
Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
A Phase 1 study testing THEO-260 in people with Ovarian Cancer, run by Theolytics Limited at 1 site in United States.
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 by the intraperitoneal route 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to Sep 2027
- Phase
- Phase 1
- 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 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Amir Jazaeri, MD, +1 (713) 745-1613, aajazaeri@mdanderson.org
Amir Jazaeri
About this study
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
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
- Ovarian Cancer
- Being tested
- THEO-260
- Keywords
- Ovarian cancer, Oncolytic virus, Intraperitoneal administration, Dose escalation
- 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
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
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Measured: Estimated at 18 months after start of enrolment
Secondary outcomes (6)
Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (maximum concentration - Cmax) of THEO-260 in blood by qPCR
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, measured by key cytokines/biomarkers in blood
Measured: Until Day 29 after first dose
Evaluate preliminary efficacy of THEO-260
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Measured: Estimated at 16 weeks
Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (time to reach maximum concentration - Tmax) of THEO-260 in blood by qPCR
Measured: Estimated at 16 weeks
Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (area under the curve - AUC) of THEO-260 in blood by qPCR
Measured: Estimated at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start13 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theolytics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Theolytics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211659
- Sponsor's protocol ID
- THEO-260-002
- Acronym
- OCTOPOD-IP
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07211659
- Acronym / sponsor ID
- OCTOPOD-IP / THEO-260-002
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Oncolytic virus, Intraperitoneal administration, Dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Theolytics LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Oct 2025 (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 by the intraperitoneal route 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 (6 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 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.
Key exclusion criteria (21 listed)
- 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).
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
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
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
6 secondary outcomes
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
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 22 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.
Clinical Trials study director
Theolytics Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THEO-260 in people with Ovarian Cancer, run by Theolytics Limited at 1 site in United States.
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 6 inclusion and 21 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 22 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 1 site in United States. 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 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.
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 (time frame: Until Day 28 after first dose). The study lists 2 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 22 Apr 2026.