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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Castration-Resistant Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: CCW702


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1a: Dose Escalation QOD<br>CCW702 administered subcutaneously QOD, dose escalating cohorts. | Drug: CCW702<br>* Investigational immunotherapy for prostate cancer<br>|
| Experimental: Part 1b: Dose Escalation Q7D<br>CCW702 administered subcutaneously Q7D, dose escalating cohorts. | Drug: CCW702<br>* Investigational immunotherapy for prostate cancer<br>|
| Experimental: Part 2: Dose Expansion<br>CCW702 administered subcutaneously Q7D at RP2D. | Drug: CCW702<br>* Investigational immunotherapy for prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities | Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0 | up to day 28 | 
| Part 1a and 1b: Select recommended phase/part 2 dose | Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts | up to 2 years | 
| Part 2: to assess clinical efficacy at the RP2D | Responses will be measured using prostate cancer working group 3 (PCWG3) criteria | up to 2 years |