ESP359 / Novartis, Mariana Oncology - LARVOL DELTA

Phase I study of [225Ac]Ac-ETN029, a DLL3-targeted radioligand therapy, in patients with advanced DLL3-expressing solid tumors. (ASCO 2026) - P1 | "Patients with prior DLL3-targeted therapy (except for SCLC) or prior RLT (except for NEPC) will be excluded. Patient enrollment began in October 2025."

Clinical • First-in-human • Metastases • P1 data • Endocrine Cancer • Gastrointestinal Neuroendocrine Carcinoma • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Gastrointestinal Neuroendocrine Carcinoma • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

ETN029: Discovery and development of a DLL3-targeting radioligand therapy for the treatment of SCLC and beyond (ACS-Fall 2025) - "Structural insights from co-crystal analysis guided additional refinements, ultimately leading to the development candidate ETN029 (also known as MC339). In CDX models (NCI-H69, SHP-77), a single dose of [225Ac]Ac-ETN029 (0.35-1.4 µCi) resulted in robust tumor regression and prolonged survival. These studies support further investigation of the novel therapeutic ETN029 as a treatment for patients with DLL3-expressing solid tumors."

Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=116 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2031 ➔ Jun 2031 | Trial primary completion date: Mar 2031 ➔ Jun 2031

Trial completion date • Trial primary completion date • Endocrine Cancer • Gastrointestinal Neuroendocrine Carcinoma • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=116 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Initiation date: Jul 2025 ➔ Oct 2025

Trial initiation date • Endocrine Cancer • Gastrointestinal Neuroendocrine Carcinoma • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=116 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Endocrine Cancer • Genito-urinary Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor