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

Recruiting now · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06783829

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

240

Starts

2025-01-22

Expected to finish

2027-03-01

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age range: 18-85 years old, male;
• ECOG score for physical condition is 0-1 points;
• Expected survival period ≥ 6 months;
• Prostate adenocarcinoma confirmed by histological or cytological examination;
• Patients with at least one metastasis lesion;
• Disease progression on or after the most-recent prior regimen;
• Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
• Testosterone was at castration level;
• Adequate organ function.

You may not qualify if…

• Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
• Unresolved to CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy;
• Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
• Uncontrollable tumor-related pain;
• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
• Other serious concomitant disease;
• Previous or co-existing malignancies;
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
• Active hepatitis B or active hepatitis C;
• Other inappropriate situation considered by the investigator.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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