A Study of SHR-4394 Injection in Subjects With Prostate Cancer

Phase 1

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: SHR4394

• Registration Number: NCT06783829
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR4394	SHR4394	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 ChengDu, Sichuan, China