Phase 1 Combination Study of MM-151 and MM-121



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2015

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A Phase 1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 and MM-121 in Heregulin Positive Cancer Patients

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151
co-administration with MM-121 at varying dose levels.

This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121 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 until a maximum tolerated combination dose is identified.
In part 2 of the study, patients with be treated with combination dose identified in part 1
of the study.

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 heregulin-positive 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.
We found this trial at
4
sites
Aurora, Colorado 80045
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Aurora, CO
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Chicago, Illinois 49201
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Chicago, IL
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Nashville, Tennessee 37212
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Nashville, TN
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Sandy Springs, Georgia 30342
Phone: 404-256-4777
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Sandy Springs, GA
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