Clinical trial · no report yet · Phase 1/Phase 2
OrigAMI-1
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
- NCT05379595 ↗
- Recruiting
- Janssen Research & Development, LLC
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 12 | |
| YouTube | 7 | |
| Podcasts | 3 |
The trial
ClinicalTrials.gov- Official 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
- Phase
- Phase 1/Phase 2
- Status
- Recruiting
- Conditions
- Advanced or Metastatic Colorectal Cancer
- Interventions
- Amivantamab IV; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan; Amivantamab
- Arms
- Cohorts A, B, and C: Amivantamab Monotherapy · Experimental
- Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) · Active comparator
- Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) · Active comparator
- Cohort F: Amivantamab + mFOLFOX6 · Active comparator
- Enrollment
- 225 (estimated)
- Primary outcomes
- Cohorts A, B, and C: Objective Response Rate (ORR)
- Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT)
- Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity
- Cohorts D and E: Number of Participants with Adverse Events (AE)
- Cohorts D and E: Number of Participants with Laboratory Values Abnormalities
- Cohorts D and E: Number of Participants with Vital Signs Abnormalities
- Cohorts F: Number of Participants with Adverse Events (AE)
- Cohorts F: Number of Participants with Laboratory Values Abnormalities
- Cohorts F: Number of Participants with Vital Signs Abnormalities
- Sponsor
- Janssen Research & Development, LLC
- Start
- Jul 29, 2022
- Primary completion
- Apr 27, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05379595 · updated Sep 25, 2026
Publications
linked from the registry- Oberstein PE, Hecht JR, Raghav K, Pietrantonio F, Arnold D, Moreno V, Van Cutsem E, Malik RA, Hong YS, Lee MA, Yu-Li Su H, Lee J, Chandana S, Cruz-Correa M, Yuan Y, Ahmad A, Lai KM, Hsu HC, Chen EX, Elez E, Lin CC, Lopez C, Prenen H, Rosello-Keranen S, Velez H, Yeh YM, Heinemann V, Eng C, Beom SH, Tejpar S, Chowdhury S, Lyu X, Kamat M, Curtin JC, Patel B, Xie J, Bhattacharya R, Schnepp RW, Yilmaz E, Iwasawa R, Daksh M, Lorenzini P, Thayu M, Baig M, Kim HS, Han SW. Amivantamab Monotherapy in Chemorefractory RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study. J Clin Oncol. 2026 Jun 10;44(17):1624-1634. doi: 10.1200/JCO-25-02187. Epub 2026 Apr 21. PubMed 42013403