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

Not Applicable

Completed

• Conditions: PSMA PET-Positive Castration-Resistant Prostate Cancer
• Interventions: Drug: 177Lu-LNC1011

• Registration Number: NCT06809426
• Lead Sponsor: Affiliated Hospital of Jiangnan University

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.

Study Timeline

• Study Start: 2023-08-21
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-24
• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
177Lu-LNC1011	177Lu-LNC1011	Successfully screened subjects will be treated with 177Lu-LNC1011 Injection during the treatment period with 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.

Primary Outcome Measures

Name	Time	Method
To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment	2-12 weeks
Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011	2-12 weeks

Secondary Outcome Measures

Name	Time	Method
The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM	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	1 day

Trial Locations

Locations (1)

Affiated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China