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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT04077021

Recruitment Status:

Active, not recruiting

Sponsor:

Calibr, a division of Scripps Research

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There are 5 Locations for this study

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University of California at San Diego
San Diego California, 92093, United States
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT04077021

Recruitment Status:

Active, not recruiting

Sponsor:


Calibr, a division of Scripps Research

How clear is this clinincal trial information?

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