Clinical Trials /

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

NCT04077021

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CBR-CCW702-3001
  • NCT ID: NCT04077021

Conditions

  • Castration-Resistant Prostatic Cancer

Interventions

DrugSynonymsArms
CCW702Part 1: Dose Escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalCCW702 is administered subcutaneously with ascending dose levels to determine maximal tolerated dose (MTD).
  • CCW702
Part 2: Dose ExpansionExperimentalCCW702 is administered subcutaneously at the recommended phase 2 dose (RP2D). Different dosing regimens will be compared.
  • CCW702

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Measure the number of first cycle dose limiting toxicities

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Calibr, a division of Scripps Research

Last Updated

January 22, 2020