Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618235
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Trial of THEO-260 in Ovarian Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa 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:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None