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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02538627
• Other study ID #: MM-151-01-01-02
• Status: Terminated
• Phase: Phase 1
• First received: August 31, 2015
• Last updated: August 31, 2017
• Start date: August 2015
• Est. completion date: October 5, 2016

Study information

• Verified date: August 2017
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 5, 2016
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• MM-151
MM-151
• MM-121
MM-121
• MM-141
MM-141
• trametinib
trametininb

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Northwestern	Chicago	Illinois
United States	Vanderbilt	Nashville	Tennessee
United States	Washington University	Saint Louis	Missouri
United States	Northside Hospital	Sandy Springs	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers		1.5 years
Secondary	Number of dose limiting toxicities (DLTs) within a group		1.5 years
Secondary	Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib		1.5 years
Secondary	Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST		1.5 years