Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Chemotherapy
Research type
Research Study
Full title
A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer
IRAS ID
1006005
Contact name
Nicola Hall
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-006629-23
Clinicaltrials.gov Identifier
Research summary
This is an open-label, multicentre, phase 1b/2 study of amivantamab (the study drug) as monotherapy (i.e., a single treatment) and in addition to standard of care (SoC) chemotherapy in participants with advanced or metastatic (cancer that has spread to a distant part of the body) colorectal cancer (CRC).
The purpose of this study is to see if amivantamab (also known as Rybrevant TM) is safe and useful for treating patients with CRC when it is given alone or in addition to SoC chemotherapies, as well as to find the best dose of amivantamab when given with chemotherapies. Participants will be enrolled into different cohorts depending on previous treatment and tumour location. Cohorts A, B, and C will receive amivantamab alone. Cohorts D and E will receive amivantamab in addition to SoC chemotherapy (mFOLFOX6 and FOLFORI, respectively).
The study consists of a Screening Phase (up to 28-days), a Treatment Phase (consisting of 28-day cycles), and a Follow-up Phase.
The UK will not take part in the phase 1b portion of this study.
Participants will be enrolled into different cohorts depending on previous treatment and tumour location. Cohorts A, B, and C will receive amivantamab alone. Cohorts D and E will receive amivantamab in addition to SoC chemotherapy (mFOLFOX6 and FOLFORI, respectively).
The study consists of a Screening Phase (up to 28-days), a Treatment Phase (consisting of 28-day cycles), and a Follow-up Phase.
The UK will not take part in the phase 1b portion of this study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0241
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion