Testing SHR-4394 Injection in People With Prostate Cancer
Tests the SHR-4394 injection's safety and effects in people with prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of SHR-4394 Injection in Subjects With Prostate Cancer
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06783829, who can take part
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT06783829
- Record updated
- 27 February 2025
- Original description
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.Read full original descriptionShow less
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
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.
Inclusion: 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.
Exclusion: 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; 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; 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 inappropriate situation considered by the investigator.