Prostate Cancer Clinical Trial
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Men ≥ 18 years of age at time of informed consent
For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
Eastern Cooperative Oncology Group performance status of 0-1
Adequate liver function
Adequate hematopoietic function
Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L)
Patient has a life expectancy of greater than 12 weeks
Exclusion Criteria:
Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
Patients with peripheral neuropathy CTCAE Grade >/= 2
Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
Patients with untreated or imminent spinal cord compression
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There are 5 Locations for this study
San Diego California, 92093, United States
Baltimore Maryland, 21287, United States
Detroit Michigan, 48201, United States
Charlottesville Virginia, 22908, United States
Milwaukee Wisconsin, 53226, United States
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