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.
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
Drug | Synonyms | Arms |
---|
CCW702 | | Part 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
Name | Type | Description | Interventions |
---|
Part 1: Dose Escalation | Experimental | CCW702 is administered subcutaneously with ascending dose levels to determine maximal tolerated dose (MTD). | |
Part 2: Dose Expansion | Experimental | CCW702 is administered subcutaneously at the recommended phase 2 dose (RP2D). Different dosing regimens will be compared. | |
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
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
September 1, 2021