The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CP-PCA07 in combination with enzalutamide in patients with castration-resistant prostate cancer (CRPC).
This is an open-label, dose-escalation, multicenter Phase 1 study. The primary objective is to assess the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) to determine the recommended Phase 2 dose (RP2D) of the combination therapy.
The secondary objective is to assess changes in Prostate-Specific Antigen (PSA) levels and pharmacokinetic characteristics.
Exploratory objectives include assessment of tumor response, disease control, progression-free survival, and biomarker analyses, including AR-V7 status, according to RECIST version 1.1 and other applicable criteria.
1. Male patients aged ≥19 years at the time of providing written informed consent.
2. Patients with histologically or cytologically confirmed castration-resistant prostate cancer without small-cell features, who have experienced treatment failure with monotherapy of Enzalutamide or Abiraterone.
3. Patients with a serum testosterone level < 50 ng/dL at screening.
4. Patients with an increase in PSA compared to baseline, confirmed by two consecutive measurements within 8 weeks prior to the date of written informed consent (with at least 1 week between measurements and an increase of ≥ 50% compared to baseline).
1. Patients who have received chemotherapy, chemoradiotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to the first administration of the investigational product (for docetaxel or cabazitaxel therapy, within 9 weeks prior to the screening date).
2. Patients diagnosed with immunodeficiency or who are in an immune-suppressed condition.
3. Patients with autoimmune diseases.
4. Patients with a pacemaker or severe heart failure [Class III or IV heart failure according to the New York Heart Association (NYHA) classification], or patients with uncontrolled arrhythmia (all patients with implanted medical devices other than a pacemaker are excluded).
Single group
CP-PCA07
DrugCP-PCA07 will be administered orally three times daily. The starting dose is 600 mg/day, with planned escalation to 900 mg/day and 1,200 mg/day based on protocol-specified 3+3 dose-escalation criteria and dose-limiting toxicity evaluation.
Enzalutamide 40 mg capsule
DrugEnzalutamide will be administered orally once daily at a fixed dose of 160 mg, with or without food, in combination with CP-PCA07.
Recommended Phase 2 Dose (RP2D) Based on Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT)
The recommended Phase 2 dose (RP2D) will be determined by assessing the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) using a 3+3 dose-escalation design. Safety and tolerability data collected during the first 12 weeks of treatment in each dose cohort will be evaluated by the Safety Review Committee (SRC)
Change From Baseline in Prostate-Specific Antigen (PSA) Levels
Descriptive statistics will be presented for the changes in Prostate-Specific Antigen (PSA) levels from baseline to each evaluated post-baseline time point.
Maximum Observed Plasma Concentration (Cmax and Cmax,ss) of Niclosamide, Metabolite M1, and Enzalutamide
To determine the peak plasma concentration (Cmax) at Day 1 and steady-state peak plasma concentration (Cmax,ss) at Day 29 for Niclosamide (administered as CP-PCA07), its metabolite M1, and Enzalutamide.
Area Under the Plasma Concentration-Time Curve (AUCt and AUCtau) of Niclosamide, Metabolite M1, and Enzalutamide
To evaluate the area under the plasma concentration-versus-time curve from time zero to the last quantifiable concentration (AUCt) at Day 1 and during a dosing interval at steady state (AUCtau) at Day 29 to assess systemic exposure.
Time to Maximum Observed Plasma Concentration (Tmax and Tmax,ss) of Niclosamide, Metabolite M1, and Enzalutamide
To measure the time to reach maximum plasma concentration (Tmax) at Day 1 and steady-state maximum plasma concentration (Tmax,ss) at Day 29.
Objective Response Rate (ORR)
The objective response rate is defined as the proportion of patients who achieve a Complete Response (CR) or Partial Response (PR) at the evaluated time points, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)
The Disease Control Rate is defined as the proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at 12 weeks after administration, assessed according to RECIST 1.1 criteria.
Incidence of New Metastases
Descriptive statistics will be presented for the incidence and evaluation of new tumor metastases using RECIST 1.1 criteria.
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