Clinical trial · Interventional
177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer
A Dosimetry Study and Dose-escalation and of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate Cancer Patients
- 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)
This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).
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 |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-LNC1011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LNC1011 Dose escalation
- description
- Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.
- interventionNames
- Drug: 177Lu-LNC1011
Primary outcomes (3)
- measure
- Dosimetry of normal organs and tumors
- timeFrame
- through study completion, an average of 4 weeks
- description
- The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-LNC1011. The dose delivered to normal organs and tumors will be recorded.
- measure
- Hematologic adverse events collection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * progressive metastatic castration-resistant prostate cancer * tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT Exclusion Criteria: * a serum creatinine level of more than 150 μmol per liter * a hemoglobin level of less than 10.0 g/dl * a white-cell count of less than 4.0× 109/L * a platelet count of less than 100 × 109/L * a total bilirubin level of more than 3 times the upper limit of the normal range * a serum albumin level of more than 3.0 g per deciliter * cardiac insufficiency
References
Publications (1)
- DERIVEDYang H, Wang J, Wen X, Guo H, Jakobsson V, Zhao T, Zeng F, Shen H, Zhang H, Liu X, Qin Y, Li X, Xiong H, Zhou Z, Zhang J, Chen X. Dansylated Amino Acid-Modified Long-Acting PSMA Derivatives 68Ga/177Lu-LNC1011 as Prostate Cancer Theranostics. J Nucl Med. 2025 May 1;66(5):739-747. doi: 10.2967/jnumed.124.268959. PMID 40113222