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
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
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
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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