MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

NCT01097460 | Completed Phase 1 Results

• 1 other identifier: MM-111-02-12-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Conditions

Breast Neoplasms

Keywords

HER2/HER3; Bispecific Antibody; Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; HER2 Positive Breast Cancer; Trastuzumab; Herceptin

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent AE's

  2 years

Secondary Outcomes (1)

• To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination

  2 years

Study Arms (1)

MM-111 + Herceptin

EXPERIMENTAL

MM-111 will be combined with Herceptin

Drug: MM-111 + Herceptin

Interventions

MM-111 + Herceptin DRUG

For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV

Also known as: Trastuzumab

MM-111 + Herceptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial)
• 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

Sponsors & Collaborators

• Merrimack Pharmaceuticals: lead

Study Sites (3)

Indiana University (IUPUI)

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MM-111; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Victor Moyo
• Organization: Merrimack Pharmaceuticals

vmoyo@merrimackpharma.com

1-617-441-1094

Study Officials

• Michaela Higgins, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 7, 2015
• Results First Posted: December 4, 2014

Record last verified: 2014-12

Locations

US (3)