Actively Recruiting
A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Led by Hinova Pharmaceuticals Inc. · Updated on 2025-03-12
417
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.
CONDITIONS
Official Title
A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older who consents to participate
- Confirmed diagnosis of prostate adenocarcinoma without small cell features
- Evidence of disease progression after medical or surgical castration, including PSA progression, soft tissue lesion progression, or new bone lesions
- Confirmed metastatic disease by imaging during screening
- Androgen blockade therapy maintained with hormone agonists or antagonists and serum testosterone \u2264 1.73 nmol/L during screening
- Failed or intolerant to prior treatments with abiraterone acetate
- Failed or intolerant to prior chemotherapy with docetaxel or unsuitable for docetaxel treatment
- Expected survival of at least 3 months
- ECOG performance status score between 0 and 2
- Laboratory tests meeting specified blood, liver, and kidney function criteria
- Willingness to use reliable contraception and not donate sperm during the study and for 3 months after last dose
You will not qualify if you...
- Received any anti-prostate cancer treatment within 4 weeks before randomization (except maintained androgen blockade therapy)
- Prior use of novel androgen receptor inhibitors such as Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119
- Known brain or central nervous system metastases
- Serious cardiovascular diseases including recent myocardial infarction, unstable angina, severe heart failure, prolonged QT interval, or uncontrolled hypertension
- Unresolved toxicities from previous treatments of grade 2 or higher (except hair loss)
- Significant gastrointestinal issues affecting drug intake or absorption
- History of serious central nervous system diseases or epilepsy
- Diagnosis of other malignant tumors within the past 5 years except certain cured skin and bladder cancers
- History of allogeneic bone marrow or organ transplantation requiring ongoing treatment
- Known immunodeficiency, active hepatitis, tuberculosis, or other active infections
- Known allergy to androgen receptor inhibitors
- Investigator judgment deeming patient unfit for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yi Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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