A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Other Tumors With EGFR Dependence; Squamous Cell Head and Neck Cancer; Non-small Cell Lung Cancer; Triple Negative Breast Cancer; Colorectal Cancer

Treatments: Drug: MM-121; Drug: Cetuximab; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451632

MM-121-05-01-05 (TCD11696)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No standard options remaining
• Adequate liver and kidney functions
• 18 years of age or above

Exclusion criteria

• History of any secondary active cancer in the last 3 years.
• Pregnant or breast feeding
• History of severe allergic reactions or contraindications to cetuximab or irinotecan

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Part 1: MM-121 + cetuximab

Experimental group

Description:

increasing doses of weekly MM-121 + weekly cetuximab

Treatment:

Drug: Cetuximab

Drug: MM-121

Part 2: MM-121 + cetuximab + irinotecan

Experimental group

Description:

increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1

Treatment:

Drug: Irinotecan

Drug: Cetuximab

Drug: MM-121