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

Calibr, a division of Scripps Research

Status and phase: Terminated; Phase 1

Conditions: Metastatic Castration-Resistant Prostate Adenocarcinoma

Treatments: Drug: CCW702

Study type: Interventional

Funder types: Other

Identifiers

NCT04077021

CBR-CCW702-3001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Part 1a: Dose Escalation QOD

Experimental group

Description:

CCW702 administered subcutaneously QOD, dose escalating cohorts.

Treatment:

Drug: CCW702

Part 1b: Dose Escalation Q7D

Experimental group

Description:

CCW702 administered subcutaneously Q7D, dose escalating cohorts.

Treatment:

Drug: CCW702

Part 2: Dose Expansion

Experimental group

Description:

CCW702 administered subcutaneously Q7D at RP2D.

Treatment:

Drug: CCW702