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

Study Identifier:
THEO-260-001
CT.gov Identifier:
NCT06618235
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-511236-27-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

The goal of this clinical trial is to establish if THEO-260 is safe to administer to adult females with ovarian cancer. It will also aim to establish if THEO-260 is able to treat ovarian cancer. The main questions it aims to answer are:

  • What medical problems do participants have when taking THEO-260?
  • At what dose is THEO-260 both safe but also shows signs of being able to treat ovarian cancer?
  • At the selected dose, test THEO-260 is a wider group of participants to confirm the safety and ability to treat ovarian cancer.

Part A will be the dose escalation/ finding part of the trial where we will aim to establish a Recommended Phase 2 Dose (RP2D).

Part B will be where the recommended RP2D is given to a larger group of participants.

Participants will:

  • Be administered 6 doses of THEO-260 over the course of 2 weeks.
  • They will then visit the clinic at regular intervals for check-ups and tests to monitor safety and THEO-260 ability to treat ovarian cancer.

To evaluate THEO-260 in patients with ovarian cancer

To demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.

To determine the recommended Phase 2 dose.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Ovarian
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female
    Age
    18+ years
    Study Drug
  • Drug: Experimental: THEO-260
    • Read More
  • Drug: Intervention/Treatment
  • Drug: Participants will:
  • Drug: Be administered 6 doses of THEO-260 over the course of 2 weeks.
  • Drug: Patients will receive THEO-260 through intravenous or intraperitoneal routes
  • Drug: THEO-260 is administered intravenously to participants, each receiving 6 doses (2 desensitisation doses, 4 target doses) over up-to 15 days.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 1.
    • 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-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).
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Ramon Yarza
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian