Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib
Phase 1
Terminated
- Conditions
- Colorectal CancerNon-small Cell Lung CancerSquamous Cell Carcinoma of the Head and Neck
- Interventions
- Registration Number
- NCT02538627
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colorectal cancer Expansion MM-141 Doses established in part 1 of the study MM-151+MM-121 Dose Escalation MM-121 MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers MM-151+ trametinib Dose Escalation MM-151 MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. MM-151+MM-141 Dose Escalation MM-151 MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers Head and neck Expansion MM-121 Doses established in part 1 of the study MM-151+MM-141 Dose Escalation MM-141 MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers MM-151+trametinib Dose Escalation MM-151 MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. Colorectal cancer Expansion MM-151 Doses established in part 1 of the study Colorectal cancer Expansion MM-121 Doses established in part 1 of the study Head and neck Expansion MM-141 Doses established in part 1 of the study Head and neck Expansion MM-151 Doses established in part 1 of the study MM-151+MM-121 Dose Escalation MM-151 MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers Colorectal cancer Expansion trametinib Doses established in part 1 of the study MM-151+ trametinib Dose Escalation trametinib MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. MM-151+trametinib Dose Escalation trametinib MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. Head and neck Expansion trametinib Doses established in part 1 of the study
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Washington University
🇺🇸Saint Louis, Missouri, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
Northside Hospital
🇺🇸Sandy Springs, Georgia, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Northwestern
🇺🇸Chicago, Illinois, United States