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RECRUITINGPhase 1INTERVENTIONAL

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

A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.

Who May Be Eligible (Plain English)

Who May Qualify: 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. your organs (liver, kidneys, etc.) are working well enough based on blood tests. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SHR4394

SHR4394

Locations (1)

West China Hospital of Sichuan University
Chengdu, Sichuan, China