Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

Merrimack Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Breast Cancer

Treatments: Drug: MM-302 Monotherapy; Drug: MM-302 in combination with trastuzumab; Drug: MM-302 in combination with trastuzumab and cyclophosphamide; Drug: MM-302 in combination with trastuzumab q3w

Study type: Interventional

Funder types: Industry

Identifiers

NCT01304797

MM-302-02-01-01

Details and patient eligibility

About

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced/unresectable or metastatic breast cancer
• Eighteen years of age or above
• Able to understand and sign an informed consent (or have a legal representative who is able to do so)
• Measurable disease according to RECIST v1.1
• ECOG Performance Score of 0 or 1
• Adequate bone marrow, hepatic, renal and cardiac function
• 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 MM-302

Exclusion criteria

• Patients for whom potentially curative anticancer therapy is available
• Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
• Symptomatic CNS disease
• Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
• Received other recent antitumor therapy
• Pregnant or breast feeding
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 4 patient groups

MM-302

Experimental group

Treatment:

Drug: MM-302 Monotherapy

MM-302 in Combination with Trastuzumab

Experimental group

Treatment:

Drug: MM-302 in combination with trastuzumab

MM-302 in Combination with Trastuzumab q3w

Experimental group

Treatment:

Drug: MM-302 in combination with trastuzumab q3w

MM-302 in Combination with Trastuzumab and Cyclophosphamide

Experimental group

Treatment:

Drug: MM-302 in combination with trastuzumab and cyclophosphamide