Clinical Trial

A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma (MCLA-158-CL02)

MOA: Petosemtamab is a bispecific antibody targeting EGFR and LGR5

Key Eligibility Criteria:

• Metastatic or locally advanced HNSCC not amenable to standard therapy with curative intent
• Progressed on or after:
  • Anti-PD-1 therapy AND
  • Plt-containing therapy for R/M disease or if disease progressed within 6 months of plt-based therapy for locally advanced disease
    • Pts should not have received >1 line of chemotherapy in incurable R/M setting
• Eligible primary tumor locations: OP, OC, HP, LX
• OPC only: p16 status by local lab IHC or central testing
• No prior anti-EGFRs unless cetuximab + radiotherapy multimodal treatment of local disease and PD ≥ 1 year post cetuximab
• Baseline fresh/archival FFPE tumor sample from R/M primary site
• Measurable disease per RECIST v1.1