Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called HRS-4357 for men with advanced prostate cancer. The main goals are to see how safe the treatment is, how the body processes it, and whether it shows any signs of being effective in fighting the cancer. The study is not yet recruiting participants, but when it starts, it will focus on adult men aged 18 and older who have been diagnosed with prostate cancer.

To join the trial, participants will need to agree to be part of the study and be able to sign a consent form. They should have a good performance status, meaning they are generally well enough to participate. However, men with certain health issues, like severe urinary problems or active infections, will not be eligible. If you qualify and decide to participate, you can expect to receive the HRS-4357 injection and undergo regular check-ups to monitor your health and how the treatment is working. This trial is an important step in finding new options for men facing advanced prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
• • 2. Male, age ≥18 years;
• • 3. ECOG score 0 - 1;
• • 4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;
• Exclusion Criteria:
• • 1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
• • 2. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
• • 3. Active syphilis infection.
• • 4. Known hypersensitivity to components of the study drug or its analogues.