Trial of THEO-260 in Ovarian Cancer Patients

NCT06618235 | Recruiting Phase 1 DMC

• 1 other identifier: THEO-260-001
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 4

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of THEO-260 [Part A]

  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.

  Until Day 28 after first dose

• Establish recommended Phase 2 dose (RP2D) for THEO-260 [Part A]

  Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data

  Estimated at 2 years

• Evaluate preliminary efficacy of THEO-260 [Part B]

  Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.

  Estimated at 16 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

THEO-260

EXPERIMENTAL

Biological: THEO-260

Interventions

THEO-260 BIOLOGICAL

Oncolytic Virus

THEO-260

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theolytics Limited: lead

Study Sites (4)

Centro Integral Oncológico Clara Campal (CIOCC) Hospital

Madrid, Spain

RECRUITING

The Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Clinical Trials

CONTACT

+441865607020; clinicaltrials@theolytics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: October 1, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); GB (3)