Evaluating SHR-4394 Injection for Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center Phase I study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-4394 injection in male subjects diagnosed with prostate cancer. Participants will receive multiple doses of the treatment while being monitored for any adverse effects and overall response to the therapy. The study focuses on patients who have experienced disease progression after prior treatments and have confirmed metastatic prostate adenocarcinoma.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Qi Shi
• Email: qi.Shi.qs16@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.