The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.
The trial will be performed in two "phases" (Periods): Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.
Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.
Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
University College London Hospital
London, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
Percentage of participants experiencing dose-limiting toxicities (DLTs)
DLTs are used to determine the maximum tolerated dose.
Time frame: 6 months
Pharmacokinetic profile of serum patritumab
Cmax and AUC
Time frame: 6 months
Pharmacokinetic profile of serum cetuximab
Cmax and AUC
Time frame: 6 months
Percentage of participants with human anti-human antibody (HAHA) formation (anti-patritumab antibodies)
Time frame: 6 months
Titer of HAHA formation (anti-patritumab antibodies)
A titer is a way of expressing concentration. Titer testing employs serial dilution to obtain approximate quantitative information from an analytical procedure that inherently only evaluates as positive or negative. The titer corresponds to the highest dilution factor that still yields a positive reading.
Time frame: 6 months
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