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).
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).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 received a dose escalation of 0.925 GBq from the previous cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGDosimetry of normal organs and tumors
The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-LNC1011. The dose delivered to normal organs and tumors will be recorded.
Time frame: through study completion, an average of 4 weeks
Hematologic adverse events collection
Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Total white cell count less than 2.5 × 10\^9/L,Platelet count less than 75 × 10\^9/L
Time frame: through study completion, an average of 6 months
Liver and renal toxic events collection
Liver and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Progressive deterioration of organ function (GFR \<30 mL/min or creatinine \> 2-fold upper limit of normal (ULN); liver enzymes \> 5-fold ULN).
Time frame: through study completion, an average of 6 months
PSA Response
The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-LNC1011. PSA response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase \<25% or PSA decrease \<50%.
Time frame: through study completion, an average of 6 months
Pharmacokinetics and dosimetry
Absorbed doses were measured in the brain, salivary glands, thyroid, cardiac content, lungs, liver, kidneys, spleen, pancreas, L2-L4 lumbar vertebrae, gastric content, and bladder content.
Time frame: Whole-body (WB) scans were performed at 2, 4, 24, 48, 72, 120, and 168 hours following intravenous administration of [177Lu]Lu-LNC1011
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