177Lu-LNC1011 / Dongcheng Pharma - LARVOL DELTA

Dosimetry and Dose-escalation Study of a Novel Long-Acting Radiopharmaceutical [ 177 Lu]Lu-LNC1011 inMetastatic Castration-Resistant Prostate Cancer Patients (EANM 2025) - No abstract available

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PSMA-targeted radioligand therapy with [177Lu]Lu-LNC1011 for metastatic castration-resistant prostate cancer: a pilot study. (PubMed, Eur J Nucl Med Mol Imaging) - P=N/A | "[177Lu]Lu-LNC1011 was well tolerated and had acceptable side effects for PSMA-targeted radioligand therapy. Tumor lesions received high radiation doses and had excellent responses to the treatment. Dose escalation studies in a larger number of patients are worth pursuing and necessary to confirm these results. URL OF REGISTRY: https://clinicaltrials.gov/study/NCT06809426?term=NCT06809 ."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Leukopenia • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: The First Affiliated Hospital of Xiamen University | Recruiting ➔ Completed | N=20 ➔ 8 | Trial completion date: Dec 2026 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dansylated Amino Acid-Modified Long-Acting PSMA Derivatives 68Ga/177Lu-LNC1011 as Prostate Cancer Theranostics. (PubMed, J Nucl Med) - "Biodistribution studies confirmed the significantly higher tumor uptake of [177Lu]Lu-LNC1011 (127.36 ± 16.95 %ID/g) over [177Lu]Lu-PSMA-617 (17.44 ± 6.29 %ID/g) at 4 h after injection, and no decrease was measured for the [177Lu]Lu-LNC1011 at up to 72 h after injection, which was corroborated with SPECT imaging. [68Ga]Ga-LNC1011 PET/CT scans of patients with metastatic castration-resistant prostate cancer identified as many lesions as [68Ga]Ga-PSMA-11 did, confirming its diagnostic efficacy. 68Ga/177Lu-LNC1011, characterized by high tumor uptake and retention along with timely clearance from normal organs and tissues, thus emerges as a promising single-molecule theranostic radioligand."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatology • Oncology • Prostate Cancer • Solid Tumor

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 (clinicaltrials.gov) - P=N/A | N=13 | Completed | Sponsor: Affiliated Hospital of Jiangnan University

New trial • Castration-Resistant Prostate Cancer • Fibrosis • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PUMCH-NM-PSMA1011: 177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Peking Union Medical College Hospital | Phase classification: P=N/A ➔ P1/2 | Initiation date: Oct 2023 ➔ May 2023

Metastases • Phase classification • Trial initiation date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dansylated Amino Acid Derived 68Ga/177Lu-LNC1011 as Prostate Cancer Theranostics (EANM 2024) - "Biodistribution studies confirmed the significantly higher tumor uptake of 177Lu-LNC1011 (127.36 ± 16.95 %ID/g) over 177Lu-PSMA-617 (17.44 ± 6.29 %ID/g) at 4 h post-injection. 68Ga/177Lu-LNC1011, characterized by high tumor uptake and timely clearance from background organs, emerges as a promising candidate for a single-molecule theranostic radioligand in preclinical and clinical."

Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Theranostic Application of 68Ga/177Lu-LNC1011: A Novel Long-Circulating PSMA Probe for Metastatic Castration-Resistant Prostate Cancer (EANM 2024) - "[68Ga] Ga-LNC1011 demonstrated non-inferior diagnostic efficacy compared to [68Ga]Ga-PSMA-11, with early tumor uptake observed. Combined with [177Lu]Lu-LNC1011 SPECT, prolonged retention of the imaging agent in the tumor was suggested. Additionally, [177Lu]Lu-LNC1011 exhibited promising therapeutic efficacy after two cycles of treatment."

Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Targeted Alpha Therapy of Prostate Cancer with Actinium-225-labeled Novel Dansylated Amino Acid Derived PSMA-Targeted Radioconjugate 225Ac-LNC1011 (EANM 2024) - "Recently, albumin binders, such as p-iodophenyl, Evans blue, and ibuprofen-modified PSMA radioligands with prolonged blood circulation, have been developed to improve tumour uptake and therapeutic effectiveness...Radioligands' distribution and tumour uptake were evaluated using single-photon emission computed tomography (SPECT/CT) imaging with 37 MBq of 177Lu-LNC1011... LNC1011, characterised by a favourable improvement in tumour uptake and rapid clearance from background organs, is a promising candidate for PRLT and should be clinically evaluated. Targeted alpha therapy holds great promise to enhance its therapeutic effect."

Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

PUMCH-NM-PSMA1011: 177Lu-LNC1011 in Patients With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=9 | Recruiting | Sponsor: Peking Union Medical College Hospital | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Development of 68Ga/177Lu-LNC1011 for theranostics of prostate cancer (SNMMI 2024) - "95 %ID/g) over 177Lu-PSMA-617 (17. 68Ga/177Lu-LNC1011, characterized by significant improvement in tumor uptake and relatively fast clearance from normal organs, emerges as a promising candidate as prostate cancer radiotheranostics."

Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Maximum Tolerated Dose, and Patient-Specific Dosimetry of [177Lu]Lu-LNC1011 in metastatic Castration-Resistant Prostate Cancer Patients (SNMMI 2024) - "The administration of [177Lu]Lu-LNC1011 at a dose of 3. 7 GBq in the treatment of mCRPC patients is well tolerated and has minimal side effects. It exhibits low uptake in the salivary glands and achieves a high tumor absorbed dose."

Clinical • Metastases • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

Metastases • New P1 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor