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177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer

RECRUITINGPhase 1/2Sponsored by Peking Union Medical College Hospital
Actively Recruiting
PhasePhase 1/2
SponsorPeking Union Medical College Hospital
Started2023-05-01
Est. completion2025-04-01
Eligibility
Age18 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06250244

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).

Eligibility

Age: 18 Years – 80 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer

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