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

Stopped early · Phase 1

Conditions studied: Colorectal Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT02538627

Run by

Merrimack Pharmaceuticals

People needed

5

Starts

2015-08-01

Expected to finish

2016-10-05

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be >18 years of age
• Patients must be able to provide informed consent
• Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
• Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
• Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.

You may not qualify if…

• Patients who are pregnant or lactating
• Patients who have an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled.)
• Patients with untreated (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
• Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Northside Hospital — Sandy Springs, Georgia, United States
• Northwestern — Chicago, Illinois, United States
• Washington University — St Louis, Missouri, United States
• Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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