177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer
NCT06250244 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-12-11
Summary
This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).
Conditions
Interventions
- DRUG
-
177Lu-LNC1011
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Zhaohui Zhu, MD · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2025-04-01
- Completion
- 2025-10-01
Countries
- China
Study Locations
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