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

Advanced Prostate Cancer Clinical Trial

Official title:

A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06006104
• Other study ID #: HRS-4357-101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 30, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xueying Zheng
• Phone: +0518-82342973
• Email: xueying.zheng.xz17[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 49
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• HRS-4357 injection
HRS-4357 injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prog Dose limiting toxicity (DLT)		up to 9 months follow-up
Primary	recommended phase 2 dose (RP2D)		up to 9 months follow-up
Primary	recommended dosing cycle.		up to 9 months follow-up
Primary	PSA50 response rate		up to 12 weeks follow-up
Secondary	Maximum plasma concentration (Cmax)		up to 6 weeks follow-up
Secondary	time to maximum plasma concentration (Tmax)		up to 6 weeks follow-up
Secondary	area under the plasma concentration-time curve (AUC)		up to 6 weeks follow-up
Secondary	clearance (Cl)		up to 6 weeks follow-up
Secondary	volume of distribution (Vz)		up to 6 weeks follow-up
Secondary	terminal half-life (t1/2)		up to 6 weeks follow-up
Secondary	cumulative urinary excretion of radioactive dose		up to 6 weeks follow-up
Secondary	Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;		up to 6 weeks follow-up
Secondary	PSA90 response rate		up to 12 weeks follow-up]
Secondary	time to PSA progression		up to 9 months follow-up
Secondary	Overall Response Rate (ORR)		up to 20 months follow-up
Secondary	Disease control Rate (DCR)		up to 20 months follow-up
Secondary	Duration of Response (DoR)		up to 20 months follow-up
Secondary	Radiographic Progression-free Survival (rPFS)		up to 9 months follow-up
Secondary	Overall Survival (OS)		up to 20 months follow-up
Secondary	Incidence and severity of AEs and SAEs		up to 20 months follow-up