Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With … (NCT07683013) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer
South Korea18 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
19 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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).
* 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.
Exclusion Criteria:
* 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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended Phase 2 Dose (RP2D) Based on Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT)
Timeframe: Up to 12 weeks after the first dose of the combination therapy