Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer

NCT07683013 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ADM-PC-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Castration-Resistant Prostate Cancer (CRPC)

Keywords

Castration-resistant prostate cancer; CRPC; CP-PCA07; Enzalutamide; Niclosamide; Phase 1; Dose escalation

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 12 weeks after the first dose of the combination therapy

Secondary Outcomes (5)

• Change From Baseline in Prostate-Specific Antigen (PSA) Levels

  Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 8 (Day 57), and Week 12 (Day 85)

• Maximum Observed Plasma Concentration (Cmax and Cmax,ss) of Niclosamide, Metabolite M1, and Enzalutamide

  Day 1 and Week 4 (Day 29): pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose

• Area Under the Plasma Concentration-Time Curve (AUCt and AUCtau) of Niclosamide, Metabolite M1, and Enzalutamide

  Day 1 and Week 4 (Day 29): pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose

• Time to Maximum Observed Plasma Concentration (Tmax and Tmax,ss) of Niclosamide, Metabolite M1, and Enzalutamide

  Day 1 and Week 4 (Day 29): pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose

• Elimination Half-life (t1/2) of Niclosamide, Metabolite M1, and Enzalutamide

  Day 1 and Week 4 (Day 29): pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours post-dose

Other Outcomes (3)

• Objective Response Rate (ORR)

  At 4, 8, and 12 weeks after the first dose of combination therapy

• Disease Control Rate (DCR)

  At 12 weeks after the first dose of combination therapy

• Incidence of New Metastases

  Before administration (Baseline) and at 12 weeks after the first dose of combination therapy

Study Arms (1)

Enzalutamide + CP-PCA07

EXPERIMENTAL

Patients will receive combination therapy with CP-PCA07 and Enzalutamide. Enzalutamide will be administered orally once daily at a fixed dose of 160 mg. CP-PCA07 will be administered orally three times daily, starting at 600 mg/day, with planned dose escalation to 900 mg/day and 1,200 mg/day according to the protocol-specified 3+3 dose-escalation criteria and dose-limiting toxicity evaluation.

Drug: CP-PCA07; Drug: Enzalutamide 40 mg capsule

Interventions

CP-PCA07 DRUG

CP-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.

Also known as: Niclosamide

Enzalutamide + CP-PCA07

Enzalutamide 40 mg capsule DRUG

Enzalutamide will be administered orally once daily at a fixed dose of 160 mg, with or without food, in combination with CP-PCA07.

Also known as: Xtandi

Enzalutamide + CP-PCA07

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male patients aged ≥19 years at the time of providing written informed consent.
• \. 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.
• \. Patients with a serum testosterone level \< 50 ng/dL at screening.
• \. 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).
• \. Patients with PSA levels ≥ 2 ng/mL both prior to the date of written informed consent and at screening.
• \. Patients with an ECOG performance status ≤ 2 and an expected survival of at least 6 months.
• \. Patients whose spouse or partner is a woman of childbearing potential must agree to use one of the protocol-specified highly effective methods of contraception from the time of study participation consent until 3 months after the last administration of the investigational product.
• \. Patients who voluntarily agree to participate in this study and provide written informed consent.

You may not qualify if:

• \. 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).
• \. Patients diagnosed with immunodeficiency or who are in an immune-suppressed condition.
• \. Patients with autoimmune diseases.
• \. 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).
• \. Patients with a history of chronic liver disease or evidence of cirrhosis.
• \. Patients with a history of gastrectomy or other conditions that may affect drug absorption.
• \. Patients with a history of deep vein thrombosis, pulmonary embolism, acute coronary syndrome, or major cerebrovascular disease within 6 months prior to screening.
• \. Patients with a history of major surgery requiring general anesthesia or assisted ventilation within 4 weeks prior to screening.
• \. Patients with active hepatitis B, a history of hepatitis B, or known active hepatitis C virus infection at screening.
• \. Patients who meet any of the following laboratory criteria at screening:
• ① Absolute neutrophil count (ANC) \< 1,500/uL without G-CSF administration within 2 weeks prior to screening
• ② Platelet \< 100,000/uL without transfusion within 2 weeks prior to screening
• ③ Hemoglobin \< 9.0 g/dL without transfusion within 2 weeks prior to screening
• ④ Serum creatinine \> 1.8 mg/dL or eGFR (or GFR) \< 40 mL/min/1.73 m2
• ⑤ AST and ALT \> 2.5 x ULN

Sponsors & Collaborators

• Hyundai Bioscience Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Niclosamide; enzalutamide

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Central Study Contacts

Hyundai Bioscience Clinical Trial Inquiries

CONTACT

+82-1544-3194; clinical@hyundaibio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-arm, multicenter, 3+3 dose-escalation Phase 1 study.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)