Objective:
Dose Expansion Cohort 1 – Amivantamab SC Monotherapy
Primary Objectives:
- To assess anti-tumor activity of amivantamab monotherapy in
participants with R/M HNSCC who have received prior
treatment with platinum-based chemotherapy and a
PD-1/PD-L1 inhibitor.
Secondary Objectives:
- To further assess anti-tumor activity of amivantamab
monotherapy in participants with R/M HNSCC who have
received prior treatment with platinum-based chemotherapy
and a PD-1/PD-L1 inhibitor.
- To characterize safety and tolerability of amivantamab
monotherapy in participants with R/M HNSCC who have
received prior treatment with platinum-based chemotherapy
and a PD-1/PD-L1 inhibitor.
- To characterize PK of amivantamab monotherapy in
participants with R/M HNSCC who have received prior
treatment with platinum-based chemotherapy and a
PD-1/PD-L1 inhibitor.
Dose Expansion Cohort 2 – Amivantamab SC in Addition to Pembrolizumab
Primary Objectives:
- To assess anti-tumor activity of amivantamab in addition to
pembrolizumab in participants with R/M HNSCC who are
treatment-naïve in the R/M setting.
Secondary Objectives:
- To further assess anti-tumor activity of amivantamab in
addition to pembrolizumab in participants with R/M HNSCC
who are treatment-naïve in the R/M setting.
Dose Confirmation Cohort 3A– Amivantamab SC in Addition to Paclitaxel
Primary Objectives:
- Determine RP2CD(s) of amivantamab in addition to paclitaxel
in participants with R/M HNSCC who have received
PD-1/PD-L1 based therapy.
- To characterize safety and tolerability of amivantamab in
addition to paclitaxel in participants with R/M HNSCC who
have received PD-1/PD-L1 based therapy.
Dose Expansion Cohort 3B– Amivantamab SC in Addition to Paclitaxel
Primary Objectives:
- To assess anti-tumor activity of amivantamab in addition to
paclitaxel in participants with R/M HNSCC who have
received PD-1/PD-L1 based therapy.
Secondary Objectives:
- To further assess anti-tumor activity of amivantamab in
addition to paclitaxel in participants with R/M HNSCC who
have received PD-1/PD-L1 based therapy.
- To further characterize the safety and tolerability of
amivantamab in addition to paclitaxel in participants with R/M
HNSCC who have received PD-1/PD-L1 based therapy.