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

NCT02538627 | Terminated Phase 1

• 1 other identifier: MM-151-01-01-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

Heregulin-positive; EGFR; ErbB3; Phase I; Oncology; Cancer; IGF-1; MEKinhibitor; IGF-1R inhibitor; KRAS; NRAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of dose limiting toxicities (DLTs) within a group

  1.5 years

• Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib

  1.5 years

• Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST

  1.5 years

Study Arms (6)

MM-151+MM-121 Dose Escalation

EXPERIMENTAL

MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers

Drug: MM-151; Drug: MM-121

MM-151+ trametinib Dose Escalation

EXPERIMENTAL

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Drug: MM-151; Drug: trametinib

MM-151+MM-141 Dose Escalation

EXPERIMENTAL

MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers

Drug: MM-151; Drug: MM-141

MM-151+trametinib Dose Escalation

EXPERIMENTAL

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Drug: MM-151; Drug: trametinib

Colorectal cancer Expansion

EXPERIMENTAL

Doses established in part 1 of the study

Drug: MM-151; Drug: MM-121; Drug: MM-141; Drug: trametinib

Head and neck Expansion

EXPERIMENTAL

Doses established in part 1 of the study

Drug: MM-151; Drug: MM-121; Drug: MM-141; Drug: trametinib

Interventions

MM-151 DRUG

MM-151

Colorectal cancer Expansion; Head and neck Expansion; MM-151+ trametinib Dose Escalation; MM-151+MM-121 Dose Escalation; MM-151+MM-141 Dose Escalation; MM-151+trametinib Dose Escalation

MM-121 DRUG

MM-121

Colorectal cancer Expansion; Head and neck Expansion; MM-151+MM-121 Dose Escalation

MM-141 DRUG

MM-141

Colorectal cancer Expansion; Head and neck Expansion; MM-151+MM-141 Dose Escalation

trametinib DRUG

trametininb

Also known as: MEKINIST

Colorectal cancer Expansion; Head and neck Expansion; MM-151+ trametinib Dose Escalation; MM-151+trametinib Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (5)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Northside Hospital

Sandy Springs, Georgia, 30342, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Vanderbilt

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

MM-151; seribantumab; Istiratumab; trametinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: October 5, 2016
• Study Completion: October 5, 2016
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

US (5)