CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Investigational immunotherapy for prostate cancer
University of California at San Diego
San Diego, California, United States
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities
Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0
Time frame: up to day 28
Part 1a and 1b: Select recommended phase/part 2 dose
Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts
Time frame: up to 2 years
Part 2: to assess clinical efficacy at the RP2D
Responses will be measured using prostate cancer working group 3 (PCWG3) criteria
Time frame: up to 2 years
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