Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
Study NCT ID:
NCT07211659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-10-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
Sponsor:
Theolytics Limited
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTOPOD-IP
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: