This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not responding to standard therapy or advanced or metastatic bladder cancer not candidate for chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of first line standard of care chemotherapy (Phase II).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Oncolytic virus
GZA ziekenhuizen campus Sint-Augustinus
Wilrijk, Antwerp, Belgium
Cliniques Universitaires St Luc
Brussels, Belgium
Ghent University Hospital
Ghent, Belgium
Institut Catala d Oncologica
Barcelona, Spain
START - Hospital Universitario Madrid Sanchinarrio
Madrid, Spain
Hospital Universitario Virgen del Rocio (HUVR)
Seville, Spain
Phase 1 - Maximum Tolerated Dose
\- Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev when administered by sub-acute fractionated IV injection (phase I Dose Escalation) and recommended dose for phase II.
Time frame: Up to Day 22
Phase 1b - Selection of suitable schedule for repeat cycle IV administration
Open label assessment of 2 repeat cycle schedules, with expansion cohort at the MTD or MFD with best repeat cycle schedule in advanced/metastatic UBC patients.
Time frame: Up to Day 134
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