95437446LUC1001
Advanced solid tumors
A Phase 1, first-in-human, open-label study of JNJ-95437446 (EGFR × MET ADC) in patients with advanced solid tumors
Phase
Compound
JNJ-95437446 (EGFR × MET ADC)
NCT identifier
NCT07107230
Enrollment
N=~380
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contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Previously diagnosed, histologically confirmed unresectable, locally advanced, or metastatic NSCLC, CRC, or HNSCC
- Participants with NSCLC adenocarcinoma and CRC must have local molecular testing to determine EGFR mutational status for NSCLC and KRAS/NRAS/BRAF mutation status for CRC
- ECOG PS of 0 or 1
- Part 1: either measurable or evaluable disease
- Part 2: ≥1 measurable lesion per RECIST v1.1
Study
design
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
ADA, antidrug antibody; ADC, antibody-drug conjugate; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CRC, colorectal cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; HNSCC, head and neck squamous cell carcinoma; KRAS, Kirsten rat sarcoma viral oncogene homolog; MET, mesenchymal epithelial transition; NRAS, neuroblastoma ras viral oncogene homolog; NSCLC, non–small cell lung cancer; PK, pharmacokinetics; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; RP2D, recommended Phase 2 dose.