177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT06250244
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2023-05-01
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LNC1011 Dose escalation
Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.
177Lu-LNC1011
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Interventions
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177Lu-LNC1011
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Eligibility Criteria
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Inclusion Criteria
* tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT
Exclusion Criteria
* a hemoglobin level of less than 10.0 g/dl
* a white-cell count of less than 4.0× 109/L
* a platelet count of less than 100 × 109/L
* a total bilirubin level of more than 3 times the upper limit of the normal range
* a serum albumin level of more than 3.0 g per deciliter
* cardiac insufficiency
18 Years
80 Years
MALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhaohui Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhaohui Zhu, MD
Role: primary
Jiarou Wang, MD
Role: backup
Other Identifiers
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PUMCH-NM-PSMA1011
Identifier Type: -
Identifier Source: org_study_id