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

NCT07683013 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-06

No results posted yet for this study

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)

Interventions

DRUG

CP-PCA07

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.

DRUG

Enzalutamide 40 mg capsule

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

Sponsors & Collaborators

  • Hyundai Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683013 on ClinicalTrials.gov