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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077021
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Calibr, a division of Scripps Research

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Castration-Resistant Prostatic Cancer Drug: CCW702 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 17, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
CCW702 is administered subcutaneously with ascending dose levels to determine maximal tolerated dose (MTD).
 Drug: CCW702
Investigational immunotherapy for prostate cancer
Experimental: Part 2: Dose Expansion
CCW702 is administered subcutaneously at the recommended phase 2 dose (RP2D). Different dosing regimens will be compared.
 Drug: CCW702
Investigational immunotherapy for prostate cancer


Outcome Measures
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Primary Outcome Measures :
  1. Part 1, Dose escalation: to assess the safety and tolerability of increasing doses of CCW702: number of first cycle dose limiting toxicities [ Time Frame: up to 4 weeks ]
    Measure the number of first cycle dose limiting toxicities

  2. Part 2, Dose expansion: to assess clinical efficacy at the recommended phase 2 dose. [ Time Frame: up to 2 years ]
    Responses will be measured using prostate cancer working group 3 (PCWG3) criteria


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077021


Contacts
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Contact: Pamela D Garzone, Ph.D 858-242-1072 pgarzone@scripps.edu

Locations
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United States, California
University of California at San Diego Recruiting
San Diego, California, United States, 92093
Contact: Arlene Araneta    858-822-5374    aaraneta@health.ucsd.edu   
Contact: Michelle Padilla    858-822-5223    Mlp002@health.ucsd.edu   
Principal Investigator: Rena McKay, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Zak    410-502-4910    rzak5@jhmi.edu   
Contact: Amber Michalik    410-502-0756    amichal2@jhmi.edu   
Principal Investigator: Mark Markowski, MD, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Victoria LaBush    313-576-8411    labushv@karmanos.org   
Principal Investigator: Elisabeth Heath, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jennifer Drake    434-297-7782    jd4cx@virginia.edu   
Contact: Milos Lesevic    434-243-0544    ml4ec@virginia.edu   
Principal Investigator: Robert Dreicer, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lauren Ekins    414-805-4767    lekins@mcw.edu   
Principal Investigator: Deepak Kilari, MD         
Sponsors and Collaborators
Calibr, a division of Scripps Research
Investigators
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Principal Investigator: Mark Markowski, MD Johns Hopkins University Hospital - Sidney Kimmel Comprehensive Cancer Center
More Information
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Publications:

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Responsible Party: Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier: NCT04077021    
Other Study ID Numbers: CBR-CCW702-3001
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases