Phase I Evaluation of NI-1801 Monotherapy and Combination with Anti-PD-1 or Paclitaxel in Advanced Mesothelin-Expressing Solid Tumors

The primary objective of this phase I study is to evaluate the safety and tolerability of the **mesothelin** x CD47 antibody NI-1801, both as a monotherapy and in combination with an Anti-PD-1 antibody or paclitaxel, in patients with advanced, metastatic, or recurrent solid mesothelin-expressing malignancies. This is clinically relevant as it aims to determine the potential therapeutic benefits and adverse effects of NI-1801, which could inform future treatment strategies for these challenging cancer types.

The clinical trial involves participants diagnosed with **advanced, metastatic, or recurrent solid mesothelin-expressing malignancies**. The study population includes both male and female subjects, encompassing an age range that includes adults and older adults. The trial population selection criteria include individuals from a vulnerable population, although specific inclusion or exclusion criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. Information regarding lifestyle considerations such as diet, physical activity, or habits is not available. The sponsor has not provided further details on the general health status of the participants.

The clinical trial is designed to evaluate the safety and efficacy of the **mesothelin** x CD47 antibody NI-1801, both as a monotherapy and in combination with an Anti-PD-1 antibody or paclitaxel, in patients with advanced, metastatic, or recurrent solid mesothelin-expressing malignancies. This is a Phase I trial, which is typically the first stage of testing in human subjects, primarily focused on assessing safety, dosage tolerance, and pharmacokinetics. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to compare the effects of the investigational drug against a control group.

The trial is expected to run from May 31, 2022, to September 30, 2025, with participant involvement lasting until the end of the study or until early termination criteria are met. Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled and randomized into different treatment arms. Regular follow-up visits will be scheduled to monitor safety, collect data on drug efficacy, and manage any adverse events. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the trial's outcomes.

Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study protocols, or if the investigator deems it necessary for their safety. The trial's design and procedures are structured to ensure the collection of high-quality data while maintaining the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date is May 31, 2022, with an anticipated end date of September 30, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the intervention's effect on the disease. The trial will likely employ standard methods for measuring and analyzing efficacy, which may include validated scales, laboratory tests, or patient-reported outcomes, depending on the nature of the intervention and the disease being studied. The schedule for these assessments is typically aligned with the trial's timeline, ensuring systematic data collection at predefined intervals. The results will contribute to understanding the intervention's potential benefits and inform subsequent trial phases.