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A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

Phase 1
18 Years
Not Enrolling
Her2 Amplified Solid Tumors, Metastatic Breast Cancer

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Trial Information

A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and
tolerability of MM-111.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced cancer that is:

- HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation

- Heregulin positive based on a study required fresh biopsy sample performed at
screening and confirmed by central laboratory

- Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue
available for sectioning and immunohistochemical staining

- Patient's cancer must have recurred or progressed following standard therapy, have
not responded to standard therapy, or for which no standard therapy exists.

- Patients must be >= 18 years of age

- Patients or their legal representatives must be able to understand and sign an
informed consent

- Patients may have measurable or non-measurable tumor(s)

- Patients should have ECOG Performance Score (PS) 0 or 1

- Patients must have adequate bone marrow reserves as evidenced by:

- Absolute neutrophil count (ANC) >= 1,500/uL and

- Platelet count >= 100,000/uL

- Hemoglobin >= 9 g/dL

- Patients must have tumor tissue amenable to biopsy

- Patients must be willing to undergo biopsy prior to treatment to MM-111

Exclusion Criteria:

- Patients for whom potentially curative antineoplastic therapy is available

- Patients who are pregnant or lactating

- Patients with an active infection or with an unexplained fever greater than 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 and/or symptomatic primary or metastatic CNS malignancies
(patients with CNS metastases who have undergone surgery or radiotherapy, whose
disease is stable, and who have been on a stable dose of corticosteroids for at least
2 weeks prior to the first scheduled day of dosing will be eligible for the trial

- Patients with known hypersensitivity to any of the components of MM-111 or who have
had hypersensitivity reactions to fully human monoclonal antibodies (patients with a
history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)

- Patients with known HIV, hepatitis B or C (if patients have previously been treated
for C and have undetectable viral loads, they can be considered eligible for the

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: To determine the Phase 2 dose based either upon the maximum tolerated dose (MTD) or maximum feasible dose in patients with Her2 amplified, heregulin positive solid tumors

Outcome Time Frame:

December 2011

Safety Issue:


Principal Investigator

Muralidhar Beeram, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The START Center for Cancer Care


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

March 2012

Related Keywords:

  • Her2 Amplified Solid Tumors
  • Metastatic Breast Cancer
  • Her2 amplified solid tumors
  • Breast Cancer
  • Her3/ErbB3
  • Bispecific Antibody
  • Breast Neoplasms



University of Southern California Norris Comprehensive Cancer Center Los Angeles, California  90089
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229
Indiana University (IUPUI) Indianapolis, Indiana  46268
Fox Chase Center Philadelphia, Pennsylvania  19111