Phase I Study of [177Lu]Lu-DFC413 and [68Ga]Ga-NNS309 in Patients with Advanced or Metastatic Solid Tumors

The primary objective of this phase I study is to evaluate the safety, tolerability, and dosimetry of [177Lu]Lu-DFC413 in patients presenting with various solid tumors, including colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer, soft tissue sarcoma, breast cancer, and triple negative breast cancer. Assessment of the preliminary activity of [177Lu]Lu-DFC413 is also conducted to determine potential therapeutic benefit. Additionally, the study aims to evaluate the imaging properties of [68Ga]Ga-NNS309. 4, 5, 6

This study involves a total of 83 patients. The study population includes both male and female participants. The age range for these subjects is categorized under codes 3 and 4. The cohort consists of individuals diagnosed with various forms of locally advanced unresectable or metastatic cancer. Specific malignancies represented in this population include colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer, and soft tissue sarcoma. Additionally, the study includes patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer or triple negative breast cancer. The population is identified as containing vulnerable individuals.

This Phase I, open-label, multi-center study is designed to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413, alongside the safety and imaging properties of [68Ga]Ga-NNS309 in patients presenting with specific solid tumors. The target conditions include colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer, soft tissue sarcoma, HR+/HER2- breast cancer, and triple negative breast cancer. The research methodology involves a sequence of study visits, beginning with a screening visit to determine eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor clinical outcomes and therapeutic effects. The total duration of the study is estimated to continue until March 2029, though individual involvement may be subject to early termination based on predefined clinical criteria.

The clinical trial is designed to evaluate efficacy in patients with locally advanced unresectable or metastatic colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer, soft tissue sarcoma, HR+/HER2- ductal or lobular breast cancer, or triple negative breast cancer.