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Trial of THEO-260 in Ovarian Cancer Patients (OCTOPOD)
EU CTIS ID: 2024-511236-27-00
What this study is testing
Part A/Phase I: To evaluate the safety and tolerability of THEO-260. To establish the recommended Phase 2 dose(s) (RP2D(s)) for further evaluation in the expansion part(s) of THEO-260-001. Part B/Phase IIa: To evaluate preliminary efficacy of THEO-260, as measured by the ORR, using computerised tomography (CT)/magnetic resonance imaging (MRI) and RECIST v1.1, at the RP2D(s) of THEO-260 identified in Part A.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol.
- Female, 18 years of age or older at the time of consent.
- Life expectancy of > 3 months.
- Adequate haematological and organ function (parameters apply).
- 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.
You likely can't join if
- 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
- 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.
- 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.
- 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.
- 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.
- Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
See the full eligibility criteria
Who can 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.
- Voluntary, written informed consent prior to trial procedures. Willingness and ability to comply with the protocol.
- Female, 18 years of age or older at the time of consent.
- Life expectancy of > 3 months.
- Adequate haematological and organ function (parameters apply).
- 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.
- ECOG performance status of 0 or 1.
- Measurable disease per RECIST / iRECIST.
- 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.
What rules you out
- 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
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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 diagnosed during the 2 weeks prior to first dose of THEO-260.
- 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.
- Patients with arterial oxygen saturation <92% on room air prior to first dose of THEO 260.
- Patients who have received any licensed or investigational vaccines within 28 days prior to Day 1.
- Prior treatment with a group B adenovirus.
- 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
- 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.
- Known contra-indications or hypersensitivity to the AxMP, paracetamol
- Known alcohol consumption in excess of 2 units per day.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.