NCT02538627

Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Detailed description

This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.

Conditions

• Colorectal Cancer
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	MM-151	MM-151
DRUG	MM-121	MM-121
DRUG	MM-141	MM-141
DRUG	trametinib	trametininb

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-10-05
• Completion: 2016-10-05
• First posted: 2015-09-02
• Last updated: 2017-09-05

Locations

5 sites across 1 country: United States