Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
Rena McKay

Description

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. In part I, patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702. In part II of the study, patients will be given the recommended phase 2 dose (RP2D) evaluating two regimens of CCW702 to determine which regimen is most efficacious. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.

Official Title

A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma

Keywords

Castration-Resistant Prostatic Cancer Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant CCW702

Eligibility

You can join if…

Open to males ages 18 years and up

  • Men ≥ 18 years of age at Screening
  • 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). One prior chemotherapy agent for mCRPC will be allowed
  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Diego accepting new patients
    San Diego California 92093 United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee Wisconsin 53226 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calibr, a division of Scripps Research
ID
NCT04077021
Phase
Phase 1
Study Type
Interventional
Last Updated