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

NCT ID: NCT06809426

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2024-10-24

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.

Conditions

PSMA PET-Positive Castration-Resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

177Lu-LNC1011

Intervention Type: DRUG

75 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections.

Interventions

177Lu-LNC1011

75 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Chunjing Yu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Countries

China

References

Hou L, Wang Y, Fu H, Chen L, Yu C, Chen X, Zhang J. PSMA-targeted radioligand therapy with [177Lu]Lu-LNC1011 for metastatic castration-resistant prostate cancer: a pilot study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4033-4043. doi: 10.1007/s00259-025-07245-8. Epub 2025 Apr 10.

Reference Type: DERIVED

PMID: 40208314 (View on PubMed)

Other Identifiers

LS2023057

Identifier Type: -

Identifier Source: org_study_id