A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers (Monotherapy)

Merrimack Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Metastatic Breast Cancer

Her2 Amplified Solid Tumors

Treatments

Drug: MM-111

Study type

Interventional

Funder types

Industry

Identifiers

MM-111-01-100

Details and patient eligibility

About

This study is an open-label Phase 1 trial of MM-111.

Full description

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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 trial)