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A Phase 1, Open-Label Study In Two Parts, Evaluating The Safety, Tolerability, Pharmacokinetics, And Clinical Activity Of CCW702 In Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma

Protocol No
CALIBR-CBR-CCW702-3001
Principal Investigator
Deepak Kilari
Phase
I
Summary
In this part of the study, increasing doses of CCW702 will be given to patients. Each patient will be assigned to a particular cohort, starting with the lowest dose cohort. Initially, the study will enroll one patient starting with the lowest dose of 0.1 µg/kg. The patient will be observed to determine if it is safe to proceed to the next higher dose. If so, the next patient will receive the next higher dose. Doses will increase by a maximum of 3 times the dose level before, for example 0.1, 0.3, 1.0, 3.0, and 10 µg/kg. CCW702 will be injected under your skin (subcutaneously) every other day for two weeks for a total of 6 doses in a 28-day cycle.
Description
The purpose of the study is to assess the safety, tolerability, the time course of the drug in your body known as pharmacokinetics, and the observed effects produced by the drug called pharmacodynamics of CCW702 (study drug) when given as an injection under your skin (subcutaneous injection) every other day for two weeks for a total of 6 doses in a twenty-eight (28) day cycle of dosing in patients like yourself who have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL