Clinical trial NCT06809426: Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer
Official title: Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PSMA PET-Positive Castration-Resistant Prostate Cancer
Keywords: PSMA
mCRPC
prostate cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluating the safety and antitumor efficacy of 177Lu-LNC1011

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old, male.
2. histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
3. meet the Prostate Cancer Working Group 3 (PCWG3) diagnosis of metastatic desmoplasia-resistant prostate cancer (mCRPC), including: a) the presence of a desmoplasia level of serum testosterone (serum testosterone \<50 ng/dL or 1.7 nmol/L); b) and the presence of one of the following: - serum PSA progression: PSA \>1 ng/mL and 2 consecutive rises in PSA 1 week apart, 2 greater than 50% of the nadir; or a bone scan suggestive of ≥2 new bone lesions; or CT or MRI suggestive of progression of soft tissue lesions (RECIST 1.1).
4. a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
5. PSMA positivity confirmed by 68Ga -PSMA PET/CT.

Exclusion Criteria:

Patients who did not meet the requirements as assessed by the investigator.

Primary outcomes:
measure: To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment
timeFrame: 2-12 weeks
measure: Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011
timeFrame: 2-12 weeks
Secondary outcomes:
measure: The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM
timeFrame: 1 day
measure: 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
timeFrame: 1 day
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References: