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)
Dose-limiting toxicity (DLT) — 3 weeks.
Maximal tolerable dose (MTD) — 3 weeks.
Adverse events (AEs) — Screening up to study completion, an average of 1 year.
Recommended phase II dose (RP2D) — Screening up to study completion, an average of 1 year.
Trial sites (1)
Facility
City
Region
Status
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
More Jiangsu HengRui Medicine Co., Ltd. trials in China
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.
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