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

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ClinicalTrials.gov Identifier: NCT02538627
Recruitment Status : Terminated (Sponsor decision)
First Posted : September 2, 2015
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Drug: MM-151 Drug: MM-121 Drug: MM-141 Drug: trametinib Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 5, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Trametinib

Arm Intervention/treatment
Experimental: MM-151+MM-121 Dose Escalation
MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
Drug: MM-151
MM-151

Drug: MM-121
MM-121

Experimental: MM-151+ trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
Drug: MM-151
MM-151

Drug: trametinib
trametininb
Other Name: MEKINIST

Experimental: MM-151+MM-141 Dose Escalation
MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
Drug: MM-151
MM-151

Drug: MM-141
MM-141

Experimental: MM-151+trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
Drug: MM-151
MM-151

Drug: trametinib
trametininb
Other Name: MEKINIST

Experimental: Colorectal cancer Expansion
Doses established in part 1 of the study
Drug: MM-151
MM-151

Drug: MM-121
MM-121

Drug: MM-141
MM-141

Drug: trametinib
trametininb
Other Name: MEKINIST

Experimental: Head and neck Expansion
Doses established in part 1 of the study
Drug: MM-151
MM-151

Drug: MM-121
MM-121

Drug: MM-141
MM-141

Drug: trametinib
trametininb
Other Name: MEKINIST




Primary Outcome Measures :
  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 [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Number of dose limiting toxicities (DLTs) within a group [ Time Frame: 1.5 years ]
  2. Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib [ Time Frame: 1.5 years ]
  3. Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST [ Time Frame: 1.5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538627


Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Northside Hospital
Sandy Springs, Georgia, United States, 30342
United States, Illinois
Northwestern
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Merrimack Pharmaceuticals

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02538627     History of Changes
Other Study ID Numbers: MM-151-01-01-02
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Keywords provided by Merrimack Pharmaceuticals:
Heregulin-positive
EGFR
ErbB3
Phase I
Oncology
Cancer
IGF-1
MEKinhibitor
IGF-1R inhibitor
KRAS
NRAS

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Trametinib
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors