NCT06618235RecruitingPhase 1
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
Theolytics Limited7 sites in 2 countries44 target enrollmentStarted: September 24, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 7
- Primary Endpoint
- Safety and tolerability of THEO-260 [Part A]
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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-
- •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-
- •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-
- •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-
- •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-
- •Received any licensed or investigational vaccines within 28 days prior to first dose of THEO-260.
Arms & Interventions
THEO-260
Experimental
Intervention: THEO-260 (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pharmacokinetics (PK) of THEO-260(Estimated at 16 weeks)
- Shedding of THEO-260(Until Day 29 after first dose)
- Systemic CRS risk after THEO-260(Until Day 29 after first dose)
- Preliminary efficacy of THEO-260 [Part A](Estimated at 16 weeks)
- Safety and tolerability of THEO-260 [Part B](Until end of trial, estimated at 1 year after start of enrolment)
Investigators
Study Sites (7)
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Related News
Theolytics Secures €8 Million EU Grant to Advance Novel Oncolytic Immunotherapy for Platinum-Resistant Ovarian Cancer- Theolytics has been awarded €8 million in non-dilutive grant funding from Horizon Europe 2025 to advance its Phase 2 OCTOPOD-IV clinical trial of THEO-260 in platinum-resistant ovarian cancer.
- THEO-260 is a novel oncolytic immunotherapy designed to kill both cancer cells and cancer-associated fibroblasts while inducing immune activation in stroma-rich solid tumors.
- The competitive funding award validates the company's innovative approach to addressing significant unmet medical needs in patients with advanced ovarian cancer, whose life expectancy is typically one year or less.
- The grant will support up to 20 patients in the Phase 2a expansion study and involves major international clinical centers including institutions in Spain, Canada, and the UK.6 months agoTheolytics Advances Novel Oncolytic Immunotherapy THEO-260 in Phase I/IIa Ovarian Cancer Trial- Theolytics is presenting data from the ongoing OCTOPOD-IV Phase I/IIa trial of THEO-260, a novel oncolytic immunotherapy targeting cancer cells and cancer-associated fibroblasts in ovarian cancer patients.
- The first-in-human trial evaluates intravenous delivery of THEO-260 in patients with high-grade serous or endometrioid ovarian cancer, with recruitment ongoing at UK sites and international expansion planned.
- A second US trial (OCTOPOD-IP) investigating intraperitoneal delivery has been initiated in collaboration with MD Anderson Cancer Center, addressing the significant unmet need in platinum-resistant ovarian cancer.
- THEO-260's differentiated mechanism targets the stromal-rich tumor microenvironment, where cancer-associated fibroblasts can comprise up to 60% of tumor volume in ovarian cancer.11 months agoTheolytics Doses First Patient in Phase I/IIa Trial of THEO-260 for Ovarian Cancer- Theolytics has initiated a Phase I/IIa trial (OCTOPOD) of THEO-260, an oncolytic immunotherapy, in patients with advanced platinum-resistant ovarian cancer (PROC).
- THEO-260 is designed to lyse cancer cells and cancer-associated fibroblasts (CAFs) while alleviating immune suppression within the tumor microenvironment.
- The trial aims to assess the safety, tolerability, and recommended Phase 2 dose of intravenously administered THEO-260, with comprehensive biomarker analysis planned.
- Preclinical data suggest THEO-260 can trigger immunogenic cell death and promote T-cell activation, offering a differentiated approach for treating ovarian cancer.last yearTheolytics Doses First Patient in Phase I/IIa Trial of THEO-260 for Ovarian Cancer- Theolytics has initiated a Phase I/IIa trial of THEO-260, an oncolytic immunotherapy, in patients with advanced-stage platinum-resistant ovarian cancer (PROC).
- THEO-260 targets both cancer cells and cancer-associated fibroblasts, aiming to overcome the immune-suppressed tumor microenvironment in ovarian cancer.
- The trial will assess the safety, tolerability, and recommended Phase 2 dose of intravenously delivered THEO-260, with comprehensive biomarker analysis planned.last year