THEO-260 for High-grade serous ovarian cancer | Endometrioid ovarian cancer

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol."}
• {"criterion_text":"- Female, 18 years of age or older at the time of consent."}
• {"criterion_text":"- Life expectancy of > 3 months."}
• {"criterion_text":"- Adequate haematological and organ function (parameters apply)."}
• {"criterion_text":"- Non-pregnant and non-lactating and surgically sterile, or post-menopausal or abstinent or if of child-bearing potential will to use a highly effective form of contraception - where applicable."}
• {"criterion_text":"- ECOG performance status of 0 or 1."}
• {"criterion_text":"- Measurable disease per RECIST / iRECIST."}
• {"criterion_text":"- Part A: 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. Part B: Advanced platinum-resistant disease: platinum-resistance as radiological recurrence/ progression within 6 months of prior platinum treatment or progression on SOC treatment or in intolerant to or has no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator."}

Exclusion criteria

• {"criterion_text":"- Patients who received prior anti-cancer treatment within 28 days (e.g., Vascular Endothelial Growth Factor A [VEGF-A] monoclonal antibody, Programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 [PD-L1] targeting agents) or 5 half-lives, (e.g., small molecules, Tyrosine Kinase Inhibitor [TKI], chemotherapy, hormonal agents, PARP inhibitors), prior to the first dose of THEO-260 AND with unresolved side-effects of prior chemotherapy must have recovered to Grade 1 per CTCAE v5.0) except fatigue, alopecia or neuropathy which must recover to Grade 2"}
• {"criterion_text":"- Currently enrolled in a clinical trial of an IMP or has used any IMP with 5 half-live prior to the first dose of THEO-260."}
• {"criterion_text":"- Radiation therapy with 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial. Short courses of palliative radiation therapy should be discussed with the Medical Monitor and Sponsor."}
• {"criterion_text":"- Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient's participation in the trial due to safety, compliance concerns or ability to evaluate response."}
• {"criterion_text":"- 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 and have been off dexamethasone for 4 weeks prior to first dose of THEO-260 with no ongoing requirement for dexamethasone or anti-epileptic drugs. Brain imaging in patients with a history of cerebral metastases or CNS involvement must not be older than 12 weeks (at the start of screening). Results of any unexpected or abnormal findings of brain imaging should be discussed with the Medical Monitor and Sponsor as part of the screening process."}
• {"criterion_text":"- Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently)."}
• {"criterion_text":"- Prior pneumonitis or history of interstitial lung disease."}
• {"criterion_text":"- Confirmed QTcF ≥470 ms on screening 12-lead ECG or history of Torsades de pointes or history of congenital long QT syndrome."}
• {"criterion_text":"- Concomitant medications that prolong the QTc interval and/or increase the risk for Torsades of Pointes that cannot be discontinued or substituted (within 5 half-lives or 14 days prior to the first dose of IMP, whichever was longer) with another drug prior to administration of IMP."}
• {"criterion_text":"- Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection are eligible. Patients positive for hepatitis C virus (HCV) antibodies are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA."}
• {"criterion_text":"- Active infection with tuberculosis (confirmed as per national guideline approved test routinely performed for TB screening at the site). Past or resolved tuberculosis is acceptable."}
• {"criterion_text":"- Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency or inhaled or intranasal corticosteroids for asthma or similar conditions) is not considered a form of systemic treatment and is permitted."}
• {"criterion_text":"- Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). All patients should be tested for active SARS-Cov-2 infection and have a negative COVID-19 result within 3 days of Day 1. Active infection with SARS-Cov-2 confirmed as per site's standard way of testing."}
• {"criterion_text":"- Patients with active human immunodeficiency virus (HIV) infection or known history of HIV infection."}
• {"criterion_text":"- Active infection requiring IV antibiotics within 2 weeks prior to first dose of THEO-260, or long-term oral therapy for systemic infection."}
• {"criterion_text":"- Known contra-indications or hypersensitivity to the excipients of the IMP."}
• {"criterion_text":"- Viral infection diagnosed during the 2 weeks prior to first dose of THEO-260."}
• {"criterion_text":"- Patients with a 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."}
• {"criterion_text":"- Patients with arterial oxygen saturation <92% on room air prior to first dose of THEO 260."}
• {"criterion_text":"- Patients who have received any licensed or investigational vaccines within 28 days prior to Day 1."}
• {"criterion_text":"- Prior treatment with a group B adenovirus."}
• {"criterion_text":"- Known risk of renal injury, including those with a past history of acute or sub-acute renal disease."}
• {"criterion_text":"- Known heart failure New York Heart Association (NYHA) Class 2-4"}
• {"criterion_text":"- Any major surgical procedure (planned or anticipated) (in the Investigator's judgement) within 4 weeks of the first dose of THEO-260 or within the anticipated treatment period."}
• {"criterion_text":"- Known contra-indications or hypersensitivity to the AxMP, paracetamol"}
• {"criterion_text":"- Known alcohol consumption in excess of 2 units per day."}
• {"criterion_text":"- Part B: Greater than a single line of anti-cancer therapy in the platinum-resistant setting. Prior treatment with paclitaxel (either alone or in combination with Bevacizumab) in the platinum-resistant setting is allowed."}

Primary endpoints

• {"endpoint_text":"- Part A: Safety and tolerability will be assessed by: 1) evaluation of DLTs and AEs (including but not limited to immunerelated AEs [irAEs]) during treatment and follow-up using NCI CTCAE v5.0 or American Society of Clinical Oncology (ASCO; for pneumonitis only) or American Society for Transplantation and Cellular Therapy (ASTCT; for CRS only). 2) Laboratory parameters. 3) Vital signs, physical examination, weight, 12-lead ECG and ECOG performance status","definition_or_measurement_approach":"Assessment by evaluation of DLTs and AEs using NCI CTCAE v5.0 (and ASCO for pneumonitis, ASTCT for CRS), laboratory parameters, vital signs, physical exam, weight, 12-lead ECG and ECOG performance status."}
• {"endpoint_text":"- Part A: Evaluation of RP2D(s) using safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and if available, anti-tumour activity data by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.","definition_or_measurement_approach":"RP2D determination based on integrated assessment of safety, tolerability, PK, PD and anti-tumour activity per RECIST v1.1."}
• {"endpoint_text":"- Part B: The response to RP2D dose(s) of THEO-260 will be assessed by ORR determined by tumour imaging according to RECIST v1.1.","definition_or_measurement_approach":"Objective response rate (ORR) assessed by tumour imaging using RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Assess PK profile of THEO-260 in blood by qPCR.","definition_or_measurement_approach":"Pharmacokinetic profile measured in blood using quantitative PCR (qPCR)."}
• {"endpoint_text":"- Assess shedding of THEO-260 in buccal, urine and faecal samples by qPCR.","definition_or_measurement_approach":"Shedding assessed by qPCR of buccal, urine and faecal samples."}
• {"endpoint_text":"- Assess systemic cytokine release following administration of THEO-260 by measurement of key markers in blood.","definition_or_measurement_approach":"Measurement of key cytokine markers in blood to assess systemic cytokine release."}
• {"endpoint_text":"- Determine response to THEO-260 as assessed: 1) by tumour imaging according to RECIST v1.1 / iRECIST. 2) Changes in CA-125. 3) Quality of Life Questionnaires","definition_or_measurement_approach":"Response assessed by tumour imaging per RECIST v1.1 / iRECIST, changes in CA-125 biomarker, and Quality of Life questionnaires."}
• {"endpoint_text":"- Part B: Safety and tolerability will be assessed by: 1) evaluation of DLTs and AEs (including but not limited to irAEs) during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only); 2) Laboratory parameters. 3) Vital signs, physical examination, weight, 12-lead ECG and ECOG performance status","definition_or_measurement_approach":"As in Part A: evaluation of DLTs and AEs using NCI CTCAE v5.0 (ASCO for pneumonitis, ASTCT for CRS), plus lab parameters, vital signs, physical exam, weight, ECG and ECOG PS."}

Spain

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

219

Number Of Sites

5

Number Of Participants

10

Primary sponsor

Full Name

Theolytics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Orion Clinical Services Limited

Responsibilities

codes 1,10,11,2,6,7,8 (as listed in sponsor duties)

Name

Simbec-Orion Laboratory Services

Responsibilities

code 4 (as listed in sponsor duties)

Third parties

• {"country":"Belgium","full_name":"Oncoradiomics","duties_or_roles":"Imaging for Exploratory Endpoints","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"The University of Texas MD Anderson Cancer Center","duties_or_roles":"code 4","organisation_type":"Educational Institution"}
• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Simbec-Orion Laboratory Services","duties_or_roles":"code 4","organisation_type":"Industry"}
• {"country":"United Kingdom","full_name":"Orion Clinical Services Limited","duties_or_roles":"codes 1,10,11,2,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Prolytic GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}