177Lu-LNC1010 / Xiamen University, Dongcheng Pharma - LARVOL DELTA

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