A Study of SHR-4394 Injection in Subjects With Prostate Cancer
Recruiting · NCT06783829 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SHR4394
What this trial is about
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 can take part
Age range
18 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- West China Hospital of Sichuan University - Chengdu, Sichuan, China