Actively Recruiting
A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-09-03
66
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.
CONDITIONS
Official Title
A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male aged 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Confirmed metastatic lesions by CT, MRI, or radionuclide bone scan
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Male participants with female partners of childbearing potential must use effective contraception from consent until 120 days after last dose
You will not qualify if you...
- Received systemic antitumor therapy within 4 weeks before study treatment
- Currently participating in another clinical trial or within 4 weeks since last dose of previous trial or five half-lives of investigational drug
- Prior or co-existing malignancies except certain treated and cured cancers with no recurrence for at least 3 years
- Cancerous meningitis or untreated central nervous system metastases
- Tumor invading or closely bordering large blood vessels with high bleeding risk
- Cancerous ascites or pleural effusion requiring recent drainage
- Severe bone injury from metastasis causing pain, fractures, or spinal cord compression within last 6 months
- Pneumonia with interstitial lung disease needing glucocorticoids or severe lung impairment
- Systemic corticosteroids or immunosuppressants within 2 weeks before first dose
- Active pulmonary tuberculosis or recent treatment less than 3 months ago
- Poorly controlled high blood pressure or history of hypertensive crisis
- Uncontrolled heart symptoms or diseases
- Arterial or venous thrombosis events within 6 months before first dose
- Difficulty swallowing pills or gastrointestinal dysfunction affecting drug absorption
- Severe infection within 1 month before first dose
- Known HIV positive or active hepatitis
- Unresolved toxicity from prior antitumor therapy worse than grade 1
- Live vaccine administered within 4 weeks before first dose or during study
- Any other condition judged by investigator to affect study results or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
K
Ke Liu, M.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here