ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Phase 2

Completed

Brief Summary: This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.

Recruitment & Eligibility

Inclusion Criteria

≥ 18 years old
Breast cancer
Recurrent brain metastases from breast cancer
At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
Neurologically stable
Karnofsky Performance Status (KPS) score ≥ 70
Adequate hematology and serum chemistry laboratory test results
Expected survival of ≥ 3 months

Exclusion Criteria

Prior treatment with ANG1005/GRN1005
Evidence of symptomatic intracranial hemorrhage
Pregnancy or lactation
Inadequate bone marrow reserve
Any evidence of severe or uncontrolled diseases
Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
History of interstitial lung disease or evidence of clinically significant interstitial lung disease
Severe cardiac conduction disturbance
Central nervous system (CNS) disease requiring immediate neurosurgery intervention
Known severe hypersensitivity or allergy to paclitaxel or any of its components

Arm && Interventions

Group	Intervention	Description
ANG1005	ANG1005	Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.

Primary Outcome Measures

Name	Time	Method
Intracranial objective response rate (iORR)	Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcome Measures

Name	Time	Method
Duration of intracranial objective response	Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate	Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response	Upon enrollment through end of study period (1 year after last patient is enrolled
Number of Patients with adverse events	Upon enrollment through end of study period (1 year after last patient is enrolled
Plasma pharmacokinetics of ANG1005	On Day 1 of Cycles 1 and 3	To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Median intracranial progression-free survival (PFS)	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria	Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit rate (iCBR) at 3 and 6 months	Upon enrollment through end of study period (1 year after last patient is enrolled)
Potential immunogenicity of ANG1005	Upon enrollment through end of study period (1 year after last patient is enrolled)

Locations (19): University of Arizona Cancer Center
🇺🇸
Tucson, Arizona, United States
UC San Diego Moores Cancer Center
🇺🇸
La Jolla, California, United States
University of California - LAC Medical Center
🇺🇸
Los Angeles, California, United States
University of Southern California - Norris Comprehensive Cancer Center
🇺🇸
Los Angeles, California, United States
UC - Irvine Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
University of Colorado Cancer Center
🇺🇸
Aurora, Colorado, United States
GRU Cancer Center - Georgia Regents University
🇺🇸
Augusta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Maryland - Greenebaum Cancer Center
🇺🇸
Baltimore, Maryland, United States
National Cancer Institute
🇺🇸
Bethesda, Maryland, United States
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University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States