OrigAMI-1
Colorectal cancer
A Phase 1b/2 study of amivantamab (EGFR × MET bispecific Ab)
monotherapy in addition to SOC chemotherapy in participants with advanced or metastatic colorectal cancer
Phase
b
Compound
Amivantamab (EGFR × MET bispecific Ab) ± mFOLFOX6 or FOLFIRI
NCT identifier
NCT05379595
Enrollment
N=~225
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Study overview & design
Key eligibility criteria*:
- Unresectable or metastatic adenocarcinoma of the colon or rectum
- Phase 1b cohorts: evaluable disease
- Phase 2 cohorts: measurable disease according to RECIST v1.1
- ECOG PS 0 or 1
- Tumor lesion amenable for biopsy
- No symptomatic or untreated brain metastasis
- No known presence or history of leptomeningeal disease
- Cohort A: left-sided CRC (no prior anti-EGFR therapy)
- Cohort B: left-sided CRC (post anti-EGFR therapy)
- Cohort C: right-sided CRC (with or without EGFR therapy)
- Cohort D: anti-EGFR treatment naive; have not received oxaliplatin-based chemotherapy in the metastatic setting
- Cohort E: anti-EGFR treatment naive, have not received irinotecan-based chemotherapy in the metastatic setting
- Cohort F: treatment naive for right-sided unresectable or metastatic CRC
Study
design
Primary outcomes:
- Objective response rate (Cohorts A–C)
- DLTs (Phase 1b Cohorts D and E)
- AEs†
- Laboratory value abnormalities†
- Vital sign abnormalities†
Secondary outcomes‡:
- Objective response rate§
- DOR§
- CBR§
- PFS†
*Not a complete list of inclusion and exclusion criteria. †Cohorts D and E. ‡Not a complete list of secondary outcomes. §Cohorts D, Phase 1b-D, Phase 1b-E, and E.
Ab, antibody; AE, adverse event; CBR, clinical benefit rate; CRC, colorectal cancer; DOR, duration of response; DLT, dose-limiting toxicity; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FOLFIRI, 5-fluorouracil, leucovorin, and irinotecan; IV, intravenous; mFOLFOX6, 5-fluorouracil, leucovorin, and oxaliplatin; PFS, progression-free survival; RECIST, Response Criteria in Solid Tumors; SOC, standard of care.