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Clinical Trials in China / NCT06783829
Recruiting Phase 1

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

NCT06783829 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 1
Started
2025-01-22
Last updated
2025-02-27

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SHR4394

SHR4394: SHR4394

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan Recruiting

More Jiangsu HengRui Medicine Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06783829 on ClinicalTrials.gov ↗ ← All trials in China