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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Oncolytic virus
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety and tolerability of THEO-260
Safety and tolerability will be assessed by: Evaluation of DLTs and AEs during treatment and follow-up using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0 or American Society of Clinical Oncology (ASCO; for pneumonitis only) or American Society for Transplantation and Cellular Therapy (ASTCT; for cytokine release syndrome \[CRS\] only).
Time frame: Until end of trial for a participant, estimated at 1 year
Establish recommended Phase 2 dose (RP2D) for THEO-260
The totality of safety and efficacy data collected will be used to assess RP2D.
Time frame: Until end of trial, estimated at 16 months after start of enrolment
Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (maximum concentration - Cmax) of THEO-260 in blood by qPCR.
Time frame: Until Day 29 after first dose
Shedding of THEO-260 in saliva, urine, and faeces
Assess shedding of THEO-260 in buccal, urine and faecal samples by qPCR.
Time frame: Until Day 29 after first dose
Risk of systemic cytokine release syndrome (CRS) after THEO-260
Assess systemic CRS following administration of THEO-260 by measurement of key markers in blood.
Time frame: Until Day 29 after first dose
Evaluate preliminary efficacy of THEO-260 - RECIST
Determine response to THEO-260 as assessed by tumour imaging according to RECIST v1.1/iRECIST.
Time frame: Until end of trial, estimated at 15 months after start of enrolment
Evaluate preliminary efficacy of THEO-260 - CA125
Efficacy will also be measured by changes in cancer antigen 125 (CA-125).
Time frame: Until end of trial, estimated at 16 months after start of enrolment
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