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MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
HER2 Amplified Breast Cancer, Metastatic or Advanced Breast Cancer

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Trial Information

MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer


Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and
the recommended Phase 2 dose will be determined.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed advanced breast cancer
that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)

- Patients must have histologically or cytologically confirmed advanced breast cancer
that is heregulin positive based on fresh tumor tissue biopsy

- The patient's cancer must have recurred, progressed or not responded to standard
chemotherapy or other standard treatment. Prior therapies may include but are not
limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes

- 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 (per RECIST 1.1) or non-measurable tumor(s) (for Phase
1)

- Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).

- Patients should have a life expectancy of at least 12 weeks

- Patients must have adequate bone marrow reserves

- Patients must have adequate hepatic function

- Patients must have adequate renal function

- Patients must be recovered from the effects of any prior surgery, radiotherapy or
other antineoplastic therapy.

- Women of childbearing potential as well as fertile men and their partners must agree
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 MM-111.

Exclusion Criteria:

- Patients who are pregnant or lactating

- Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F)
during screening visits or on the first scheduled day of dosing.

- Patients with untreated and/or symptomatic metastatic CNS malignancies.

- Patients with known hypersensitivity to any of the components of MM-111 or who have
had hypersensitivity reactions to fully human monoclonal antibodies, including
Herceptin.

- Patients who have received other recent antitumor therapy including:

- Treatment with Herceptin within the 28 days prior to the first scheduled day of
dosing with MM-111

- Investigational therapy administered within the 28 days prior to the first
scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving
investigational therapy is acceptable once a time interval equal to at least
five half-lives of the investigational agent has passed.)

- Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and
having passed the time of any actual or anticipated toxicities) prior to the
first scheduled dose of MM-111

- Patients who have previously received MM-111

- Patients with NYHA Class III or IV congestive heart failure or LVEF < 50%

- Patients with a history of allogeneic transplant

- Patients with known HIV, hepatitis B or C

- Patients with any other medical or psychological condition deemed by the Investigator
to be likely to interfere with a patient's ability to sign informed consent,
cooperate and participate in the study, or interfere with the interpretation of the
results

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the safety of MM-111 + Herceptin in combination

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Michaela Higgins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

MM-111-02-12-02

NCT ID:

NCT01097460

Start Date:

March 2010

Completion Date:

December 2012

Related Keywords:

  • HER2 Amplified Breast Cancer
  • Metastatic or Advanced Breast Cancer
  • HER2/HER3
  • Bispecific Antibody
  • Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • HER2 Positive Breast Cancer
  • Trastuzumab
  • Herceptin
  • Breast Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Indiana University (IUPUI)Indianapolis, Indiana  46268