Castration-Resistant Prostate Cancer (CRPC)Phase 1NCT07683013
Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer
A Phase 1 study testing CP-PCA07 and Enzalutamide 40 mg capsule in people with Castration-Resistant Prostate Cancer (CRPC), run by Hyundai Bioscience Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Castration-Resistant Prostate Cancer (CRPC)
- What is being tested?
- CP-PCA07 and Enzalutamide 40 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2026to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 5. Patients with PSA levels ≥ 2 ng/mL both prior to the date of written informed consent and at screening.
- 6. Patients with an ECOG performance status ≤ 2 and an expected survival of at least 6 months.
- 7. 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.
- 8. Patients who voluntarily agree to participate in this study and provide written informed consent.
Who cannot join
- 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).
- 5. Patients with a history of chronic liver disease or evidence of cirrhosis.
- 6. Patients with a history of gastrectomy or other conditions that may affect drug absorption.
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- 7. Patients with a history of deep vein thrombosis, pulmonary embolism, acute coronary syndrome, or major cerebrovascular disease within 6 months prior to screening.
- 8. Patients with a history of major surgery requiring general anesthesia or assisted ventilation within 4 weeks prior to screening.
- 9. Patients with active hepatitis B, a history of hepatitis B, or known active hepatitis C virus infection at screening.
- 10. 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
- ⑥ Total bilirubin > 2.0 x ULN
- 11. Patients expected to have hypersensitivity to the active ingredient or components of the investigational product.
- 12. Patients who have received another investigational drug or investigational medical device within 4 weeks prior to the first administration of the investigational product.
- 13. Patients deemed by the investigator to be unsuitable for participation in the study or unable to comply with the study requirements due to other diseases or conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Chang Wook Jeong, MD, PhD
About this study
Official title: An Open-Label, Dose-Escalation, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer
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.
Read more
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.
Read the detailed description
This is an open-label, single-arm, multicenter Phase 1, 3+3 dose-escalation study evaluating CP-PCA07 administered in combination with enzalutamide in patients with castration-resistant prostate cancer (CRPC). A 12-week dose-limiting toxicity (DLT) evaluation period will be implemented for each cohort. A Safety Review Committee (SRC) will function as the independent body for safety monitoring and dose-escalation decisions.
- Being tested
- CP-PCA07, Enzalutamide 40 mg capsule
- Keywords
- Castration-resistant prostate cancer, CRPC, CP-PCA07, Enzalutamide, Niclosamide, Phase 1, Dose escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-PCA07Drug
Also called Niclosamide
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.
Enzalutamide 40 mg capsuleDrug
Also called Xtandi
Enzalutamide will be administered orally once daily at a fixed dose of 160 mg, with or without food, in combination with CP-PCA07.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CP-PCA07; Drug: Enzalutamide 40 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 12 weeks after the first dose of the combination therapy
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
To measure the time to reach maximum plasma concentration (Tmax) at Day 1 and steady-state maximum plasma concentration (Tmax,ss) at Day 29.
Measured: 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
To estimate the terminal elimination half-life (t1/2) of Niclosamide, its metabolite M1, and Enzalutamide, where mathematically feasible based on the plasma concentration-time profile.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, multicenter, 3+3 dose-escalation Phase 1 study.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683013
- Sponsor's protocol ID
- ADM-PC-001
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No