NCT07211659

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

A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Theolytics Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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? The clinical trial follows a dose escalation/ finding design where we will aim to establish a Recommended Phase 2 Dose (RP2D). Participants will: * Be administered 6 doses of THEO-260 via an intraperitoneal (IP) route of administration 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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	THEO-260	Oncolytic virus

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-10-08
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study