A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.
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
Assessment of DLTs and AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Laboratory parameters and clinical safety assessments.
Time frame: Until Day 28 after first dose
Establish recommended Phase 2 dose (RP2D) for THEO-260
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Time frame: Estimated at 18 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: Estimated at 16 weeks
Shedding of THEO-260
Detection of THEO-260 in buccal, urine and faecal samples.
Time frame: Until Day 29 after first dose
Systemic CRS risk after THEO-260
Incidence and severity of CRS, measured by key cytokines/biomarkers in blood
Time frame: Until Day 29 after first dose
Evaluate preliminary efficacy of THEO-260
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Time frame: Estimated at 16 weeks
Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (time to reach maximum concentration - Tmax) of THEO-260 in blood by qPCR
Time frame: Estimated at 16 weeks
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Pharmacokinetic (PK) profile of THEO-260
Assess PK profile (area under the curve - AUC) of THEO-260 in blood by qPCR
Time frame: Estimated at 16 weeks