Evaluating SHR-4394 Injection for Prostate Cancer
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
This study is testing a new injection called SHR-4394 to see if it is safe and effective for men with advanced prostate cancer who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06783829 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-85 with confirmed metastatic prostate adenocarcinoma who have experienced disease progression on previous therapies.
Not a fit: Patients with uncontrolled tumor-related pain or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.