Phase I/II study to evaluate the anti-tumour activity of 177 LU-OPS201
Research type
Research Study
Full title
A MULTICENTRE, OPEN-LABEL PHASE I/II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, BIODISTRIBUTION AND ANTI-TUMOUR ACTIVITY OF 177LU-OPS201 WITH COMPANION IMAGING 68Ga-OPS202 PET/CT IN PREVIOUSLY TREATED SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC CANCERS EXPRESSING SOMATOSTATINRECEPTOR 2 (SSTR2)
IRAS ID
252360
Contact name
Merina Ahmed
Contact email
Sponsor organisation
Ipsen Pharma
Eudract number
2017-005173-39
Duration of Study in the UK
4 years, 3 months, 6 days
Research summary
This is a multicentre, open-label phase I/II study to evaluate the safety, tolerability, biodistribution and anti-tumour activity of 177 Lu-OPS201 with companion imaging 68Ga-OPS202 PET/CT in previously treated subjects with locally advanced or metastatic cancers expressing somatostatin receptor 2 (sstr2). The phase 1 of the study will be performed in approximately 8 sites in North America and in Europe.
Participants in this study will be screened with a radioactive tracer, 68Ga-OPS202, which, when injected in the blood circulation, specifically binds to these receptors (sstr2) to identify participants whose cancer has enough sstr2 to be treated with the study treatment 177Lu-OPS201. 177Lu-OPS201 binds also to the sstr2 to allow the radioactive part (177Lu) reducing and eliminating the cancer cells.
Therefore, the purpose of this research study is to evaluate the safety of the study treatment 177Lu-OPS201 and define its recommended treatment schedule. Another purpose of this research study is to evaluate the role of the tracer 68Ga-OPS202 in detecting cancers with sstr2 and following participants’ cancer(s)’ changes after being treated with 177Lu-OPS201.During phase I, up to 30 subjects will be enrolled for treatment with 177Lu-OPS201. Based on the current knowledge on the proportion of subjects presenting with sstr2-positive tumours, it is anticipated that approximately 55 to 60 subjects will need to be administered 68Ga-OPS202 for PET imaging screening.
30 subjects will be enrolled for treatment with 177Lu-OPS201 in phase 1 of the study; 172 additional subjects are planned to be enrolled in phase 2.
The primary objective of this study is to evaluate the safety and tolerability and to define the maximum tolerated cumulative activity (MTCA) of fractionated intravenous (i.v.) administration over two cycles of 177Lu-OPS201 in previously treated subjects with locally advanced or metastatic cancers expressing sstr2 as identified by 68Ga-OPS202 Positron Emission Tomography/Computed Tomography (PET/CT) scans.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0511
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion