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

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Prostate Cancer

Treatments: Drug: HRS-4357 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06006104

HRS-4357-101

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

HRS-4357 injection

Experimental group

Treatment:

Drug: HRS-4357 injection