Head & Neck Clinical Trials

Squamous Cell Carcinoma

24004: 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) – 24004 

STAR TRIAL; CURRENTLY OPEN AT BENSALEM ONLY

Eligible primary tumors: oropharynx, oral cavity, hypopharynx, larynx; Investigator choice monotherapy: methotrexate, cetuximab, docetaxel

• Phase – 3
• Stage(s) – Incurable, metastatic/current
• Line of Therapy – 2nd
• Investigational Drug – Petosemtamab
• Drug Class– anti-EGFR and anti-LGR5
• Mechanism of Action: Petosemtamab: Low fucose, common light chain human full-length IgG1 bispecific antibody targeting EGFR and LGR5.

Esophageal

24169: A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206) (JZP598-206)

• Phase – II
• Stage(s) – locally advanced, unresectable, or metastatic solid tumors
• Line of Therapy – Participants in all cohorts must have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit
• Investigational Drug – zanidatamab
• Mechanism of Action – Zanidatamab is a bispecific, HER2-directed antibody
• Biomarker(s) – HER2 IHC 3+ overexpression