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

Jiangsu HengRui Medicine Co., Ltd.0 sites49 target enrollmentSeptember 30, 2023

ConditionsAdvanced Prostate Cancer

InterventionsHRS-4357 injection

DrugsHRS-4357 injection

Overview

Phase: Phase 1
Intervention: HRS-4357 injection
Conditions: Advanced Prostate Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 49
Primary Endpoint: Prog Dose limiting toxicity (DLT)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 30, 2023

End Date

October 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
•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.
•Active syphilis infection.
•Known hypersensitivity to components of the study drug or its analogues.

Arms & Interventions

HRS-4357 injection

Intervention: HRS-4357 injection

Outcomes

Primary Outcomes

Prog Dose limiting toxicity (DLT)

Time Frame: up to 9 months follow-up

PSA50 response rate

Time Frame: up to 12 weeks follow-up

recommended dosing cycle.

Time Frame: up to 9 months follow-up

recommended phase 2 dose (RP2D)

Time Frame: up to 9 months follow-up

Secondary Outcomes

cumulative urinary excretion of radioactive dose(up to 6 weeks follow-up)
Overall Response Rate (ORR)(up to 20 months follow-up)
volume of distribution (Vz)(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)
Maximum plasma concentration (Cmax)(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)
terminal half-life (t1/2)(up to 6 weeks follow-up)
time to PSA progression(up to 9 months follow-up)
Overall Survival (OS)(up to 20 months follow-up)
time to maximum plasma concentration (Tmax)(up to 6 weeks follow-up)
Incidence and severity of AEs and SAEs(up to 20 months follow-up)
PSA90 response rate(up to 12 weeks 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)