XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects may result from blocking the growth of new blood vessels that help the tumors survive.
This is an open-label, ascending-dose study of XMT-1107 administered intravenously over 90 minutes every 21 days (1 cycle). Blood sampling for PK analyses will be performed immediately prior to dosing and after dosing. Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 4.0 (CTCAE v4.0)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
6 mg XMT-1107 administered by I.V. (in the vein) administered over 90 min, once every 21 days : until progression or unacceptable toxicity develops
University of MD Greenbaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States
The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks.
Time frame: Adverse events are assessed during each treatment cycle.
Assess the pharmacokinetics (PK) of XMT-1107 and its release product
Time frame: Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle
Determine the recommended Phase 2 dose of XMT-1107
Time frame: Throughout Cycle 1
Assess the safety of XMT-1107.
Time frame: Throughout Cycle 1
Observe for evidence of anti-tumor activity by XMT-1107.
Time frame: Course of study
Monitor the effect of XMT-1107 on MetAP2 inhibition in leukocytes from patients
Time frame: Cycle 1 and Cycle 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.