OrigAMI-4

• Research type

  Research Study

• Full title

  A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

• IRAS ID

  1009340

• Contact name

  Kevin Harrington

• Contact email

  kevin.harrington@icr.ac.uk

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2023-508418-40

• Research summary

  This is an open-label, multicentre, phase 1b/2 study evaluating the safety, tolerability (the degree to which overt adverse effects of a drug can be tolerated by a patient), and anti-tumour activity of amivantamab (the study drug) alone, and amivantamab in addition to pembrolizumab or paclitaxel (standard care treatments) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

  Despite recent advances in the treatment of HNSCC, patients continue to experience significant morbidity and mortality, underscoring the need to improve therapeutic approaches. Mesenchymal epithelial transition (MET) and the epidermal growth factor receptor (EGFR) are both antigens (a type of protein), both of which can be found on cancer cells. In laboratory studies, amivantamab binds to MET and EGFR on a cancer cell, and the cell cannot get the signals it needs to grow. Given the significant roles of EGFR and MET in HNSCC, amivantamab could provide targeted therapy for this population of high unmet clinical need.

  Participants in this study will be enrolled into 1 of 4 treatment cohorts:
  • Cohort 1: Amivantamab alone
  • Cohort 2: Pembrolizumab and Amivantamab
  • Cohorts 3A and 3B: Paclitaxel and Amivantamab

  Amivantamab will be administered via subcutaneous injection (i.e., under the skin). Both paclitaxel and pembrolizumab will be administered via an intravenous (IV) infusion (i.e., directly into the vein).

  The study will consist of a Screening period of up to 28 days, a Treatment period consisting of 21-day cycles (including an End of Treatment visit), and a Follow-up period.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  24/LO/0090

• Date of REC Opinion

  11 Mar 2024

• REC opinion

  Further Information Favourable Opinion