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Trial Title:
177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT ID:
NCT06250244
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
PSMA
177Lu
mCRPC
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-LNC1011
Description:
[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe.
Arm group label:
LNC1011 Dose escalation
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).
Detailed description:
[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 underwent sequential 50% dose escalations until the
observation of dose-limiting toxicity (DLT).
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
86-13611093752
Email:
13611093752@163.com
Contact backup:
Last name:
Jiarou Wang, MD
Phone:
86-13269163729
Email:
ChristinaWang97@163.com
Start date:
October 1, 2023
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250244
