Evaluating the safety and antitumor efficacy of 177Lu-LNC1011
This is a prospective, single-center, single-arm, open IIT clinical study evaluating the safety and anti-tumor efficacy of 177Lu-LNC1011 Injection in patients with PSMA-positive metastatic desmoplasia-resistant prostate cancer (mCRPC). Thirteen patients are expected to be enrolled. Subjects will be required to sign an informed consent form prior to screening, and successful screened subjects will be treated with 177Lu-LNC1011 Injection as 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses during the treatment period. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
75 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections.
Affiated Hospital of Jiangnan University
Wuxi, Jiangsu, China
To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment
Time frame: 2-12 weeks
Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011
Time frame: 2-12 weeks
The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM
Time frame: 1 day
The change of SUV (SUVmax, SUVmean) in 68Ga-PSMA PET/CT imaging before and after receiving 177Lu-LNC1011 treatment as assess by PMOD version 4.3
Time frame: 1 day
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