Status:
TERMINATED
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Calibr, a division of Scripps Research
Conditions:
Metastatic Castration-Resistant Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04077021
Start Date
July 17 2020
End Date
October 21 2022
Last Update
May 12 2023
Active Locations (5)
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1
University of California at San Diego
San Diego, California, United States, 92093
2
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
University of Virginia
Charlottesville, Virginia, United States, 22908