Recruiting
Phase 1

THEO-260

Sponsor:

Theolytics Limited

Code:

NCT07211659

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

THEO-260

Study Details

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 by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.

Conditions

Ovarian Cancer

Study ID

NCT07211659

Start date

Feb 13, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

  • 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 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.

Exclusion Criteria:

  • 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.
  • 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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: THEO-260

Interventions

THEO-260

Oncolytic virus

Primary outcome measure

  • Safety and tolerability of THEO-260 [ Time Frame: Until Day 28 after first dose ]
  • Establish recommended Phase 2 dose (RP2D) for THEO-260 [ Time Frame: Estimated at 18 months after start of enrolment ]

Central Contacts and Locations

Central contacts

Clinical Trials

+441865607020clinicaltrials@theolytics.com

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Amir Jazaeri, MD

+1 (713) 745-1613aajazaeri@mdanderson.org

Principal Investigator:

Amir Jazaeri

More Information

Sponsor

Theolytics Limited

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Ovarian cancer
  • Oncolytic virus
  • Intraperitoneal administration
  • Dose escalation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Theolytics Limited on 2026-04-22.