Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

NCT ID: NCT06006104

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRS-4357 injection

Group Type EXPERIMENTAL

HRS-4357 injection

Intervention Type DRUG

HRS-4357 injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRS-4357 injection

HRS-4357 injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
2. Male, age ≥18 years;
3. ECOG score 0 - 1;
4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;

Exclusion Criteria

1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
2. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
3. Active syphilis infection.
4. Known hypersensitivity to components of the study drug or its analogues.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xueying Zheng

Role: CONTACT

+0518-82342973

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRS-4357-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of HRS-2189 Combined HRS-5041 in Prostate Cancer
NCT06738745 NOT_YET_RECRUITING PHASE2