177Lu-LNC1010 / Xiamen University, Lannacheng Biotechnology - LARVOL DELTA

A Prospective, Single-Center, Single-Arm, Exploratory Study of 177Lu-LNC1010 Peptide Receptor Radionuclide Therapy for Advanced Neuroendocrine Tumors. (PubMed, J Nucl Med) - "The objective response rate and disease control rate were high and positively correlated with improved PFS and OS. Appropriate patient selection and earlier intervention may further optimize the therapeutic benefit."

Journal • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor

A Prospective, Single-Center, Single-Arm, Exploratory Study of 177Lu-LNC1010 Peptide Receptor Radionuclide Therapy for Advanced Neuroendocrine Tumors (SNMMI 2026) - "PRRT with 3.3 GBq/cycle of 177Lu-LNC1010 was well tolerated and exhibited an acceptable safety profile. The ORR and DCR were high and positively correlated with improved PFS and OS. Appropriate patient selection and earlier intervention may optimize therapeutic benefit."

Clinical • Metastases • Neuroendocrine Tumor • Oncology • Solid Tumor

A Prospective, Single-Center, Single-Arm, Exploratory Study of 177Lu-LNC1010 Peptide Receptor Radionuclide Therapy for Advanced Neuroendocrine Tumors (SNMMI 2026) - "PRRT with 3.3 GBq/cycle of 177Lu-LNC1010 was well tolerated and exhibited an acceptable safety profile. The ORR and DCR were high and positively correlated with improved PFS and OS. Appropriate patient selection and earlier intervention may optimize therapeutic benefit."

Clinical • Metastases • Neuroendocrine Tumor • Oncology • Solid Tumor

Safety, dosimetry, and efficacy of an optimized long-acting somatostatin analog for peptide receptor radionuclide therapy in metastatic neuroendocrine tumors: From preclinical testing to first-in-human study. (PubMed, Acta Pharm Sin B) - "Previous studies have shown that an SSTR2 agonist combined with albumin binding moiety Evans blue (denoted as 177Lu-EB-TATE) is characterized by a higher tumor uptake and residence time in preclinical models and in patients with metastatic NETs. Preliminary PRRT efficacy results showed an 83% disease control rate and a 42% overall response rate after two 177Lu-LNC1010 treatment cycles. These encouraging findings warrant further investigations through multicenter, prospective, and randomized controlled trials."

Journal • P1 data • Preclinical • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR2

Evaluation of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: The First Affiliated Hospital of Xiamen University | Recruiting ➔ Completed

Trial completion • Oncology • SSTR

Safety, Dosimetry, and Efficacy of an Optimized Long-acting Somatostatin Analog for Peptide Receptor Radionuclide Therapy in Metastatic Neuroendocrine Tumors: from Preclinical Testing to First-in-Humans Study (EANM 2024) - "However, A potential disadvantage of 177Lu-DOTATATE is its rapid blood clearance, resulting in relatively short tumor retention...No significant difference in whole-body mean effective dose was observed between 177Lu-LNC1010 and 177Lu-EB-TATE (0.23±0.06 vs. 0.23±0.08 mSv/MBq, P=1.00), however ,177Lu-LNC1010 exhibited 2.7-, 4.0-, and 3.0-fold higher radiation doses in the metastatic lymph nodes, liver, and other metastases than those of 177Lu-EB-TATE, respectively... The first-in-human trial with 177Lu-LNC1010 is well tolerated in patients with advanced NETs, with high radiation doses delivered to the tumor lesions. In addition, the dose-escalation study identified 3.3 GBq/cycle as the optimal therapeutic dose for future trials. Further investigations through multicenter, prospective, and randomized controlled trials are needed."

Metastases • P1 data • Preclinical • Endocrine Cancer • Hematological Disorders • Hepatology • Neuroendocrine Tumor • Oncology • Solid Tumor • Thrombocytopenia • SSTR2

Preclinical and clinical evaluation of a radiolabeled LNC1010 as a theranostic agent for molecular imaging and therapy in nasopharyngeal carcinomas (EANM 2024) - "Compared to 177Lu-DOTATATE, 177Lu-LNC1010 demonstrated significantly increased tumor uptake and retention in NPCs, thereby improving the therapeutic efficacy and extending the clinical indication of PRRT, providing a promising treatment option in patients with advanced NPC."

Preclinical • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • SSTR • SSTR2

Evaluation of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University | Phase classification: P1 ➔ P1/2 | N=20 ➔ 30

Enrollment change • Phase classification • Oncology • SSTR

Development of 177Lu‑LNC1010 for Peptide Receptor Radionuclide Therapy in Patients with Metastatic Neuroendocrine Tumors: from preclinical research to First-in-Human, Dose-escalation Study (SNMMI 2024) - "However, A potential disadvantage of 177Lu-DOTATATE is its rapid blood clearance, resulting in relatively short tumor retention...However, A potential disadvantage of 177Lu-DOTATATE is its rapid blood clearance, resulting in relatively short tumor retention...G3 thrombocytopenia was recorded in one patient in Group D (EB-TATE, 3... The first-in-human trial with 177Lu-LNC1010 is well tolerated in patients with advanced NETs, with high radiation doses delivered to the tumor lesions. Further investigations through multicenter, prospective, and randomized controlled trials are needed."

Metastases • P1 data • Preclinical • Endocrine Cancer • Hematological Disorders • Hepatology • Neuroendocrine Tumor • Oncology • Solid Tumor • Thrombocytopenia • SSTR2

177Lu-EB-LM3 in Nasopharyngeal Carcinoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University | Not yet recruiting ➔ Recruiting

Enrollment open • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • SSTR

177Lu-EB-LM3 in Nasopharyngeal Carcinoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P1 trial • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • SSTR