Conditions: Colorectal Cancer Squamous Cell Head and Neck Cancer Non-small Cell Lung Cancer Triple Negative Breast Cancer Other Tumors With EGFR Dependence
Keywords: Metastatic Colorectal cancer Kras wild-type Squamous cell head and neck cancer Non-small cell lung cancer Triple negative breast cancer EGFR ErbB3 MM-121 Cetuximab Irinotecan
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Detailed description:
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.

Arms:
arm 1: increasing doses of weekly MM-121 + weekly cetuximab arm 2: increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1

Interventions: intervention 1: MM-121 intervention 2: Irinotecan intervention 3: Cetuximab
Intervention descriptions: intervention 1: escalating doses MM-121 IV QW intervention 2: 180 mg/m2 IV Q2W intervention 3: escalating doses cetuximab IV QW

Protocol document: