NCT06006104Not yet recruitingPhase 1
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 enrollmentStarted: September 30, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 49
- Primary Endpoint
- Prog Dose limiting toxicity (DLT)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: HRS-4357 injection (Drug)
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)
Investigators
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