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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 22
- Locations
- 5
- Primary Endpoint
- Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Part 1a: Dose Escalation QOD
CCW702 administered subcutaneously QOD, dose escalating cohorts.
Intervention: CCW702 (Drug)
Part 1b: Dose Escalation Q7D
CCW702 administered subcutaneously Q7D, dose escalating cohorts.
Intervention: CCW702 (Drug)
Part 2: Dose Expansion
CCW702 administered subcutaneously Q7D at RP2D.
Intervention: CCW702 (Drug)
Outcomes
Primary Outcomes
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
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
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
Secondary Outcomes
No secondary outcomes reported