N=~287
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Key eligibility criteria*:
- Cohorts 1–5: histologically or cytologically confirmed R/M HNSCC considered incurable with local therapies
- Cohort 6: histologically or cytologically confirmed locally advanced HNSCC that is considered curable by surgery
- ECOG PS 0 or 1
- Adequate organ and bone marrow function without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor 7 days prior to the date of laboratory test
Primary outcomes:
Cohorts 1, 2, 3B, 4, and 5
- Objective response rate
Cohort 3A
- DLTs
- TEAEs
Cohort 6
- Major pathologic response
Secondary outcomes†:
Cohorts 1, 2, 3B, 4, and 5
- DOR
- CBR
- OS
- PFS
- TEAEs
Cohort 6
- OS
- TEAEs
- EFS
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
Ab, antibody; CBR, clinical benefit rate; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; EGFR, epidermal growth factor receptor; HNSCC, head and neck squamous cell carcinoma; IV, intravenous; MET, mesenchymal epithelial transition; OS, overall survival; PFS, progression-free survival; QW, weekly; Q3W, every 3 weeks; RECIST, Response Criteria in Solid Tumors; R/M, recurrent or metastatic; RP2CD, recommended Phase 2 combination dose; SC, subcutaneous; SOC, standard of care; TEAE, treatment-emergent adverse event.