Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients

NCT07211659 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: THEO-260-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Ovarian cancer; Oncolytic virus; Intraperitoneal administration; Dose escalation

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of THEO-260

  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

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

  Estimated at 18 months after start of enrolment

Secondary Outcomes (6)

• Pharmacokinetic (PK) profile 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

• Evaluate preliminary efficacy of THEO-260

  Estimated at 16 weeks

• Pharmacokinetic (PK) profile of THEO-260

  Estimated at 16 weeks

Study Arms (1)

THEO-260

EXPERIMENTAL

Biological: THEO-260

Interventions

THEO-260 BIOLOGICAL

Oncolytic virus

THEO-260

Eligibility Criteria

• Age: 18 Years+
• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theolytics Limited: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

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

Study Officials

• Clinical Trials

  Theolytics Ltd

  STUDY DIRECTOR

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: October 1, 2025
• First Posted: October 8, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)