Clinical trial NCT06006104: Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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