Phase 1 Evaluation of NDI-219216 in Advanced Solid Tumors with/without Microsatellite Instability and Deficient Mismatch Repair

The primary objective of this study is to evaluate the safety and tolerability of **NDI-219216** in patients with **advanced solid tumors**, both with and without **microsatellite instability** and/or **deficient mismatch repair**. This is clinically relevant as it aims to determine the potential of NDI-219216 as a therapeutic option for patients with these challenging cancer types, which often have limited treatment options and poor prognosis.

The clinical trial involves a total of **80 participants** diagnosed with **advanced solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to ensure a diverse representation of the general adult population, including those considered part of a vulnerable population. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria. The selection process aimed to encompass a broad demographic to accurately assess the treatment's efficacy across different segments of the population.

The clinical trial is designed as a **Phase 1** study to evaluate the investigational product in patients with **advanced solid tumors**. The trial employs a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The estimated duration of the trial extends from the recruitment start date on October 17, 2025, to the anticipated end date on December 31, 2031. Participants will be involved in the study for a period that aligns with the trial's objectives and protocol requirements.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following successful inclusion, participants will undergo a series of follow-up visits at specified intervals. These visits are designed to monitor the participants' health status, assess the investigational product's effects, and ensure adherence to the study protocol. The end-of-study visit marks the conclusion of a participant's involvement, where final assessments are conducted to gather comprehensive data on the investigational product's safety and efficacy.

Participant involvement is expected to last throughout the trial's duration unless specific conditions necessitate early termination. Such conditions may include adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design and procedures are structured to maintain scientific rigor while prioritizing participant safety and data integrity.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided dataset. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an initial investigation into the safety and potential efficacy of the intervention. The trial is scheduled to commence recruitment on October 17, 2025, with an estimated completion date of December 31, 2031. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 1 trials typically focus on safety and dosage, with preliminary efficacy data being collected. The trial will likely employ standard methods for data collection and analysis, consistent with Phase 1 objectives, to ensure the reliability and validity of the findings. The absence of detailed endpoints suggests that the trial may utilize exploratory measures to assess efficacy, potentially including biomarker analysis or patient-reported outcomes, depending on the investigational product and disease context. The trial's design will adhere to regulatory standards to ensure the integrity of the data collected throughout the study period.