Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors

The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• ECOG status 0 - 1

• Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type

• Dose expansion: CRC (KRAS-WT) and head & neck cancer subjects only

  1. must be able to provide 2 fresh tumor biopsy samples
  2. must have failed one prior cetuximab-containing treatment

Exclusion Criteria:

• Symptomatic brain metastasis
• Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
• Any condition requiring chronic use of steroids
• Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
• History of glucose intolerance
• History of cetuximab infusion reactions
• Women of child-bearing potential unwilling or unable to use acceptable contraception methods