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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077021
Recruitment Status : Active, not recruiting
First Posted : September 4, 2019
Last Update Posted : October 3, 2022
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. 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.

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Adenocarcinoma Drug: CCW702 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 1a: Dose Escalation QOD
CCW702 administered subcutaneously QOD, dose escalating cohorts.
 Drug: CCW702
Investigational immunotherapy for prostate cancer
Experimental: Part 1b: Dose Escalation Q7D
CCW702 administered subcutaneously Q7D, dose escalating cohorts.
 Drug: CCW702
Investigational immunotherapy for prostate cancer
Experimental: Part 2: Dose Expansion
CCW702 administered subcutaneously Q7D at RP2D.
 Drug: CCW702
Investigational immunotherapy for prostate cancer


Outcome Measures
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Primary Outcome Measures :
  1. Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities [ Time Frame: up to day 28 ]
    Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0

  2. Part 1a and 1b: Select recommended phase/part 2 dose [ Time Frame: up to 2 years ]
    Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts

  3. Part 2: to assess clinical efficacy at the RP2D [ 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 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
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


Locations
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United States, California
University of California at San Diego
San Diego, California, United States, 92093
United States, Maryland
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Calibr, a division of Scripps Research
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: October 3, 2022
Last Verified: September 2022

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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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Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases