First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calibr, a division of Scripps Research

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