BP29842 – A Phase Ia/Ib Study of RO6874281 in Metastatic Solid Tumors
Research type
Research Study
Full title
An open-label, multicentre, dose-escalation, phase Ia/Ib study to evaluate safety, pharmacokinetics, and therapeutic activity of RO6874281, an immunocytokine consisting of interleukin 2 variant (Il-2v) targeting fibroblast activation protein-(FAP), as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C)
IRAS ID
213487
Contact name
Anne Armstrong
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2015-002251-97
Duration of Study in the UK
2 years, 1 months, 10 days
Research summary
Summary of Research
At present, breast cancer (BC) and head and neck cancer (HNC) which is locally advanced (spread to nearby tissues or lymph nodes) or metastatic (spread from the primary cancer site to another organ or tissue elsewhere in the body) remain incurable diseases, with the main aim of treatment to maximise patient’s survival and quality of life.
This study aims to evaluate the safety, tolerability and early signs of activity of RO6874281 in combination with trastuzumab in patients with HER2-positive metastatic or recurrent BC following pretreatment with obinutuzumab (Part B) and in combination with cetuximab in metastatic or recurrent or locally advanced squamous cell carcinoma of the head and neck following pretreatment with obinutuzumab (Part C).
A total of approximately 180 patients will be recruited into this first in human study globally. RO6874281 is being currently investigated as a single agent in patients with advanced and/or metastatic solid tumors in Part A of the study.
Part B will consist of multiple escalating doses of RO6874281 with obinutuzumab pretreatment in combination with trastuzumab followed by an extension cohort where the maximum tolerated dose (MTD) and/or the optimum biologic dose (OBD) and/or the recommended dose for the further development of RO6874281 in combination with trastuzumab will be determined.
Part C will be of similar design and determine the MTD and/or the OBD and/or the recommended dose for the further development of RO6874281 in combination with trastuzumab.
Drug treatment will continue until the patient’s disease progresses (worsens), the patient starts a different drug treatment, there is unacceptable toxicity, or the patient or study doctor decides to stop treatment. The study will continue for approximately 3 years
In the UK it is expected that 10 patients will be enrolled at 3 participating study centres.
The study is sponsored by F. Hoffman-La Roche Ltd.
Summary of Results
Please see link to the lay summary:
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REC name
London - Central Research Ethics Committee
REC reference
16/LO/2078
Date of REC Opinion
6 Dec 2016
REC opinion
Favourable Opinion