Clinical trial · Interventional
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
NCT06809426CI-TRIAL-00085513completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluating the safety and antitumor efficacy of 177Lu-LNC1011
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PSMA PET-Positive Castration-Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-LNC1011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-LNC1011
- description
- 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.
- interventionNames
- Drug: 177Lu-LNC1011
Primary outcomes (2)
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHou 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