Clinical trial
Phase 1 Trial Assessing Safety, Maximum Tolerated Dose, and Patient-Specific Dosimetry of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate
Name
PUMCH-NM-PSMA1011
Description
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).
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-04-01
Trial end
2024-10-01
Status
Recruiting
Treatment
177Lu-LNC1011
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Arms:
LNC1011 Dose escalation
Size
9
Primary endpoint
Dosimetry of normal organs and tumors
through study completion, an average of 4 weeks
Hematologic adverse events collection
through study completion, an average of 6 months
Liver and renal toxic events collection
through study completion, an average of 6 months
Eligibility criteria
Inclusion Criteria:
* progressive metastatic castration-resistant prostate cancer
* tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT
Exclusion Criteria:
* a serum creatinine level of more than 150 μmol per liter
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ESTIMATED'}}
Updated at
2024-02-09
1 organization
1 product
1 indication
Organization
Peking Union Medical College HospitalProduct
177Lu-LNC1011