Evaluation of Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Advanced Unresectable or Metastatic NSCLC, BC, PDAC, and CRC.

The primary objective of this Phase I open-label, multi-center study is to evaluate the **safety** and **tolerability** of [177Lu]Lu-NNS309 in patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC), breast cancer (BC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC). Assessing safety and tolerability is crucial to determine the potential of [177Lu]Lu-NNS309 as a therapeutic option for these malignancies, which are often associated with poor prognosis and limited treatment options.

The clinical trial involves a total of **48 participants** diagnosed with **locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC)**, **breast cancer (BC)**, **pancreatic ductal adenocarcinoma (PDAC)**, or **colorectal cancer (CRC)**. The study population includes both male and female subjects, with an age range spanning from young adults to older adults. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the principal inclusion or exclusion criteria for this study.

This clinical trial is a **Phase I** open-label, multi-center study designed to evaluate the safety, tolerability, dosimetry, and preliminary activity of **[177Lu]Lu-NNS309** in patients with specific types of cancer, including locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC), breast cancer (BC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC). The trial is expected to commence recruitment on December 29, 2024, and is projected to conclude by June 26, 2030. The study employs a non-randomized, open-label design, allowing for the collection of comprehensive safety and efficacy data in a real-world setting.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough medical evaluation, including a review of medical history and relevant diagnostic tests. Following successful screening, participants will enter the treatment phase, during which they will receive the investigational product. Regular follow-up visits will be scheduled to monitor safety, tolerability, and any potential adverse events. These visits will also include assessments of dosimetry and preliminary activity of the treatment. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement will vary depending on individual response and tolerability, with the possibility of early termination if significant adverse effects are observed or if the participant withdraws consent. The study is designed to ensure participant safety while gathering critical data to inform future research phases. Conditions that may lead to early termination include the occurrence of severe adverse events, non-compliance with study protocols, or any other factors deemed necessary by the study investigators to protect participant welfare.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used alongside the experimental medication. The absence of such information suggests that the focus is solely on the experimental treatment, although this cannot be confirmed without further details.

Details regarding the **participant compliance monitoring** and specific **dosing schedules** are not included in the provided data. The lack of this information indicates that the trial documentation may require additional input to ensure comprehensive understanding and adherence to the study protocol.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is December 29, 2024, with an anticipated end date of June 26, 2030. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy through various measures, which may include symptom improvement scores, biomarker levels, or other relevant clinical indicators. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, and possibly patient-reported outcomes at predetermined timepoints. The trial's focus on safety and dosage suggests that efficacy assessments will be integrated with these primary objectives, using appropriate tools and instruments to ensure accurate and reliable data collection.