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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).
[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).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 received a dose escalation of 0.925 GBq from the previous cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNC1011 Dose escalation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-LNC1011 | Drug | [177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry of normal organs and tumors | 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. | through study completion, an average of 4 weeks |
| Hematologic adverse events collection | Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Total white cell count less than 2.5 × 10^9/L,Platelet count less than 75 × 10^9/L | through study completion, an average of 6 months |
| Liver and renal toxic events collection | Liver and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0:Progressive deterioration of organ function (GFR <30 mL/min or creatinine > 2-fold upper limit of normal (ULN); liver enzymes > 5-fold ULN). | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response | The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-LNC1011. PSA response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%. | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, MD | Contact | 86-13611093752 | 13611093752@163.com | |
| Jiarou Wang, MD | Contact | 86-13269163729 | ChristinaWang97@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40113222 | Derived | Yang 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. |
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| Pharmacokinetics and dosimetry | Absorbed doses were measured in the brain, salivary glands, thyroid, cardiac content, lungs, liver, kidneys, spleen, pancreas, L2-L4 lumbar vertebrae, gastric content, and bladder content. | Whole-body (WB) scans were performed at 2, 4, 24, 48, 72, 120, and 168 hours following intravenous administration of [177Lu]Lu-LNC1011 |