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

February 25, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • ChengDu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Ping Feng
        • Contact:
        • Principal Investigator:
          • Qiang Wei
        • Principal Investigator:
          • Qiang Dong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR4394
Drug: SHR4394
SHR4394

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recommended phase II dose (RP2D)
Time Frame: Screening up to study completion, an average of 1 year.
Screening up to study completion, an average of 1 year.
Adverse events (AEs)
Time Frame: Screening up to study completion, an average of 1 year.
Screening up to study completion, an average of 1 year.
Dose-limiting toxicity (DLT)
Time Frame: 3 weeks.
3 weeks.
Maximal tolerable dose (MTD)
Time Frame: 3 weeks.
3 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
Duration of response (DOR)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
Disease control rate (DCR)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.
overall survival (OS)
Time Frame: Up to approximately 2 years.
Up to approximately 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-4394-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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