Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

Phase 1

Completed

Brief Summary: This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.

Recruitment & Eligibility

Inclusion Criteria

Females with confirmed breast cancer
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
- At least one regimen must have been for locally advanced or metastatic disease
- Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
- Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
- Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
Documented progressive disease within 6 months of the last regimen
Adequate bone marrow, renal and liver function
Signed informed consent

Main

Exclusion Criteria

Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
Neuropathy > NCI-CTCAE Grade 1
Active brain metastases.
New York Heart Association class III or IV heart disease
Unstable angina
Uncontrolled arrhythmia
A marked baseline prolongation of QT/QTc interval
Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients	throughout the study
To determine the MTD of CR011-vcMMAE in breast cancer patients	throughout the study

Secondary Outcome Measures

Name	Time	Method
Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)	throughout the study

Locations (5): Florida Cancer Specialists
🇺🇸
Ft. Myers, Florida, United States
Hematology Oncology Associates
🇺🇸
Lake Worth, Florida, United States
Georgia Cancer Specialists
🇺🇸
Atlanta, Georgia, United States
Tennessee Oncology
🇺🇸
Nashville, Tennessee, United States
Cornell University
🇺🇸
New York, New York, United States