N=~225
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Key eligibility criteria*:
- Unresectable or mCRC
- Phase 1b cohorts: evaluable disease
- Phase 2 cohorts: measurable disease according to RECIST v1.1
- ECOG PS 0 or 1
- Cohorts A–E: No identified mutations in KRAS, NRAS, BRAF, EGFR ectodomains, or ERBB2/HER2 amplification
- Cohorts A–C: Received ≥2 but ≤3 prior lines of systemic therapy in the metastatic setting
- Cohorts D and E: ≤1 prior line of systemic therapy in the metastatic setting
- 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 xaliplatin-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 mCRC
Primary outcomes:
- ORR (Cohorts A–C)
- DLTs (Phase 1b Cohorts D and E)
- AEs†
- Laboratory value abnormalities†
- Vital sign abnormalities†
Secondary outcomes‡:
- ORR
- DOR§
- CBR§
- PFS§
*Not a complete list of inclusion and exclusion criteria. †Cohorts D, E, and F. ‡Not a complete list of secondary outcomes. §Cohorts D, Phase 1b-D, Phase 1b-E, E, and F.
Ab, antibody; AE, adverse event; BRAF, v-raf murine sarcoma viral oncogene homolog B1; 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; ERBB2, erythroblastic oncogene B; FOLFIRI; 5-fluorouracil, leucovorin, and irinotecan; HER2, human epidermal growth factor receptor 2; IV, intravenous; KRAS, Kristen rat sarcoma viral oncogene homolog; mCRC, metastatic colorectal cancer; MET, mesenchymal epithelial transition; mFOLFOX6, 5-fluorouracil, leucovorin, and oxaliplatin; NRAS, neuroblastoma RAS viral oncogene homolog; ORR, objective response rate; PFS, progression-free survival; RECIST v1.1, Response Criteria in Solid Tumors version 1.1; Q2W, every other week; SC, subcutaneous; SOC, standard of care.