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RECRUITINGPHASE1

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

A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer

NCT06783829•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

January 22, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

February 27, 2025

Enrollment

240

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

SHR4394

DRUG

Contacts

Qi Shi

CONTACT

0518-82342973 qi.Shi.qs16@hengrui.com

Yueling Wang

CONTACT

021-60453139 yueling.wang@hengrui.com

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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