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

NCT06809426 | Completed

• 1 other identifier: LS2023057
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the safety and antitumor efficacy of 177Lu-LNC1011

Conditions

PSMA PET-Positive Castration-Resistant Prostate Cancer

Keywords

PSMA; mCRPC; prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

177Lu-LNC1011

EXPERIMENTAL

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.

Drug: 177Lu-LNC1011

Interventions

177Lu-LNC1011 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.

177Lu-LNC1011

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old, male.
• histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
• 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).
• a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
• PSMA positivity confirmed by 68Ga -PSMA PET/CT.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

Related Publications (1)

• 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.

  PMID: 40208314 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 5, 2025
• Study Start: August 21, 2023
• Primary Completion: October 14, 2024
• Study Completion: October 24, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

CN (1)