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 intravenously 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
44
Oncolytic Virus
Centro Integral Oncológico Clara Campal (CIOCC) Hospital
Madrid, Spain
RECRUITINGThe Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
RECRUITINGImperial College Healthcare NHS Trust, Hammersmith Hospital
London, United Kingdom
Safety and tolerability of THEO-260 [Part A]
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 [Part A]
Determination of RP2D will be based on the totality of safety, PK and preliminary efficacy data
Time frame: Estimated at 2 years
Evaluate preliminary efficacy of THEO-260 [Part B]
Determine tumour response by RECIST v1.1 and iRECIST and changes in CA-125.
Time frame: Estimated at 16 weeks
Pharmacokinetics (PK) of THEO-260
Assess PK parameters of THEO-260
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, measurement by key cytokines/biomarkers in blood.
Time frame: Until Day 29 after first dose
Preliminary efficacy of THEO-260 [Part A]
Determine tumour response by RECIST v1.1 and iRECIST, changes in CA-125 and patient reported outcomes using EORTC QoL questionnaires
Time frame: Estimated at 16 weeks
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Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford, United Kingdom
RECRUITINGSafety and tolerability of THEO-260 [Part B]
Assessment of AEs during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only), plus Lab oratory parameters and clinical safety assessments.
Time frame: Until end of trial, estimated at 1 year after start of enrolment