Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.

Inclusion Criteria:

• Most recent regimen contains both platinum and cetuximab (Phase II, group B).
• ECOG Performance Status (PS) ≤ 2.
• Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
• Measurable disease as determined by RECIST v1.1.

Exclusion Criteria:

• Previous anti-HER3 antibody treatment.
• Symptomatic brain metastasis.
• Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
• Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
• Inadequate end organ function.
• Ongoing diarrhea CTCAE Grade ≥ 2. Other protocol-defined inclusion/exclusion criteria may apply