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

NCT ID: NCT06783829

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2027-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR4394

Group Type: EXPERIMENTAL

SHR4394

Intervention Type: DRUG

SHR4394

Interventions

SHR4394

SHR4394

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Shi

Role: CONTACT

qi.Shi.qs16@hengrui.com

0518-82342973

Yueling Wang

Role: CONTACT

yueling.wang@hengrui.com

021-60453139

Facility Contacts

Qiang Wei

Role: primary

wq933@hotmail.com

18980601425

Other Identifiers

SHR-4394-101

Identifier Type: -

Identifier Source: org_study_id