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
Janssen Research & Development, LLC
Summary
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts).
Description
Colorectal cancer (CRC) is a major global health concern and the third most common cancer worldwide. Amivantamab (also known as RYBREVANT or JNJ-61186372) is a fully human immunoglobulin (Ig) G1-based bispecific antibody (Ab) directed against the epidermal growth factor (EGF) and mesenchymal epithelial transition (MET) receptors, with evidence of preclinical activity against non-small cell lung cancer (NSCLC) tumors with activating EGF receptor (EGFR) mutations, the T790M and C797S second-site resistance EGFR mutations, overexpressed wild-type EGFR, as well as with activation of the MET pathwa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum * Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification. Additional cohort-specific requirements: * Phase (Ph) 2 (Cohorts A…
Interventions
- BiologicalAmivantamab IV
Amivantamab will be administered as intravenous infusion.
- BiologicalFluorouracil
Fluorouracil will be administered as intravenous infusion.
- BiologicalLeucovorin
Leucovorin will be administered as intravenous infusion.
- BiologicalOxaliplatin
Oxaliplatin will be administered as intravenous infusion.
- BiologicalIrinotecan
Irinotecan will be administered as intravenous infusion.
- BiologicalAmivantamab
Amivantamab will be administered.
Locations (53)
- O Neal Comprehensive Cancer Center at UABBirmingham, Alabama
- University of Southern CaliforniaLos Angeles, California
- University of California, Los Angeles UCLALos Angeles, California
- Georgetown University HospitalWashington D.C., District of Columbia
- H Lee Moffitt Cancer CenterTampa, Florida
- University of Maryland School of MedicineBaltimore, Maryland