Prostate Cancer
Conditions
Brief 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.
Interventions
DRUGSHR4394
SHR4394
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended phase II dose (RP2D) | Screening up to study completion, an average of 1 year. |
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to approximately 2 years. |
| Duration of response (DOR) | Up to approximately 2 years. |
| Disease control rate (DCR) | Up to approximately 2 years. |
| overall survival (OS) | Up to approximately 2 years. |
Countries
China
Contacts
Primary ContactQi Shi
Backup ContactYueling Wang
Outcome results
None listed