* BP42675 - RO7122290 in COLORECTAL ADENOCARCINOMA
Research type
Research Study
Full title
AN OPEN LABEL, MULTICENTER, PHASE IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI TUMOR ACTIVITY OF RO7122290, A FIBROBLAST ACTIVATION PROTEIN A (FAP) TARGETED 4 1BB LIGAND (CD137L), IN COMBINATION WITH CIBISATAMAB WITH OBINUTUZUMAB PRE TREATMENT, IN PARTICIPANTS WITH PREVIOUSLY TREATED, METASTATIC, MICROSATELLITE-STABLE COLORECTAL ADENOCARCINOMA WITH HIGH CEACAM5 EXPRESSION
IRAS ID
292127
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-003328-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 16 days
Research summary
Patients with advanced solid tumours, including metastatic colorectal cancer (mCRC), have benefitted from recent treatment advances in cancer immunotherapies, such as checkpoint inhibitors (CPI).
However, the majority of mCRC patients have microsatellite stable [MSS] tumours, which appears to be primary refractory (become resistant to previous treatments) to CPI therapy. Combination therapies such as proposed in this study may help overcome resistance mechanisms.The aim of this phase 1b open label study is to:
1) Test the safety of RO7122290 when given in combination with cibisatamab at different doses, following pre-treatment with obinutuzumab.
2) Determine the optimal dose of RO7122290 in patients with previously treated, metastatic, MSS colorectal adenocarcinoma with high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 – a type of gene) expression.The study consists of two parts:
Part 1: A Once weekly RO7122290 dose-escalation part
Part II: In which selected dose levels of RO7122290 from Part I will be explored every 3 weeks.Cibisatamab will be administered (IV) every 3 weeks in both Part I and Part II
Obinutuzumab will be administered (IV) as pre-treatment prior to cycle 1, day 1 of cibisatamab.
Approximately 100 participants will take part in the study worldwide and approximately 10 participants from 2 UK sites.
This study will enrol patients with mCRC that has recurred (relapsed) or become resistant to previous treatments (refractory) and meet the study eligibility criteria.
The maximum duration of the study for each participant will be 24 months (excluding survival follow-up).
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1.0, dated 27-Nov-2020
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0253
Date of REC Opinion
25 Feb 2021
REC opinion
Further Information Favourable Opinion