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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Prostate Cancer
• Intervention / Treatment: Drug: HRS-4357 injection

• Study Type: Interventional
• Enrollment (Estimated): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xueying Zheng; Phone Number: +0518-82342973; Email: xueying.zheng.xz17@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-4357 injection	Drug: HRS-4357 injection; HRS-4357 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prog Dose limiting toxicity (DLT)	up to 9 months follow-up
recommended phase 2 dose (RP2D)	up to 9 months follow-up
recommended dosing cycle.	up to 9 months follow-up
PSA50 response rate	up to 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax)	up to 6 weeks follow-up
time to maximum plasma concentration (Tmax)	up to 6 weeks follow-up
area under the plasma concentration-time curve (AUC)	up to 6 weeks follow-up
clearance (Cl)	up to 6 weeks follow-up
volume of distribution (Vz)	up to 6 weeks follow-up
terminal half-life (t1/2)	up to 6 weeks follow-up
cumulative urinary excretion of radioactive dose	up to 6 weeks follow-up
Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;	up to 6 weeks follow-up
PSA90 response rate	up to 12 weeks follow-up]
time to PSA progression	up to 9 months follow-up
Overall Response Rate (ORR)	up to 20 months follow-up
Disease control Rate (DCR)	up to 20 months follow-up
Duration of Response (DoR)	up to 20 months follow-up
Radiographic Progression-free Survival (rPFS)	up to 9 months follow-up
Overall Survival (OS)	up to 20 months follow-up
Incidence and severity of AEs and SAEs	up to 20 months follow-up

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HRS-4357-101

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