Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06618235
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of THEO-260 in Ovarian Cancer Patients
Sponsor:
Theolytics Limited
Organization:
Study Overview
Official Title:
A Phase I/IIa, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 in Patients With High Grade Serous or Endometrioid Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2025-09
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
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?
* At the selected dose, test THEO-260 is a wider group of participants to confirm the safety and ability to treat ovarian cancer.
Part A will be the dose escalation/ finding part of the trial where we will aim to establish a Recommended Phase 2 Dose (RP2D).
Part B will be where the recommended RP2D is given to a larger group of participants.
Participants will:
* Be administered 6 doses of THEO-260 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?
* At the selected dose, test THEO-260 is a wider group of participants to confirm the safety and ability to treat ovarian cancer.
Part A will be the dose escalation/ finding part of the trial where we will aim to establish a Recommended Phase 2 Dose (RP2D).
Part B will be where the recommended RP2D is given to a larger group of participants.
Participants will:
* Be administered 6 doses of THEO-260 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: