A Study of SHR-4394 Injection in Subjects With Prostate Cancer

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SHR-4394, which is an injection designed to treat men with prostate cancer. The goal of the study is to learn about the safety and effectiveness of this medication, as well as how it is processed in the body. The trial is currently looking for male participants aged 18 to 85 who have been diagnosed with prostate cancer and have experienced disease progression despite previous treatments. To qualify, participants should be in good physical condition, have adequate organ function, and not have received certain other cancer treatments in the past month.

If you or someone you know is interested in joining, participants can expect to receive the SHR-4394 injection and will be closely monitored for any side effects or improvements in their condition. This study is taking place at multiple centers, meaning there are various locations where men can participate. It’s important to talk to a healthcare provider to see if this study is a good fit and to understand what being part of a clinical trial entails.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age range: 18-85 years old, male;
• • 2. ECOG score for physical condition is 0-1 points;
• • 3. Expected survival period ≥ 6 months;
• • 4. Prostate adenocarcinoma confirmed by histological or cytological examination;
• • 5. Patients with at least one metastasis lesion;
• • 6. Disease progression on or after the most-recent prior regimen;
• • 7. Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
• • 8. Testosterone was at castration level;
• • 9. Adequate organ function.
• Exclusion Criteria:
• • 1. Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
• • 2. Unresolved to CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy;
• • 3. Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
• • 4. Uncontrollable tumor-related pain;
• • 5. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
• • 6. Other serious concomitant disease;
• • 7. Previous or co-existing malignancies;
• • 8. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
• • 9. Active hepatitis B or active hepatitis C;
• • 10. Other inappropriate situation considered by the investigator.