Clinical trial · Interventional
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
NCT06006104CI-TRIAL-00069020unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-4357 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-4357 injection
- interventionNames
- Drug: HRS-4357 injection
Primary outcomes (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.