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First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT04077021•Calibr, a division of Scripps Research

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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
•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

Locations (5)

University of California at San Diego

San Diego, California, United States

Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Virginia

Charlottesville, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

July 17, 2020

Primary Completion Date

October 21, 2022

Completion Date

October 21, 2022

Last Updated

May 12, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-Resistant Prostate Adenocarcinoma

Interventions

CCW702

DRUG