Dose Escalation and Cohort Expansion Study of KB-0742 in Relapsed or Refractory Solid Tumors and Non-Hodgkin Lymphoma

The primary objective of this study is to evaluate the safety and tolerability of **KB-0742** in participants with **relapsed or refractory solid tumors** or **non-Hodgkin lymphoma**. This is clinically relevant as it aims to determine the appropriate dosage and potential adverse effects of the investigational drug, which is crucial for developing effective treatment options for these challenging conditions.

The clinical trial involves a total of **120 participants** diagnosed with **relapsed or refractory solid tumors** or **non-Hodgkin lymphoma**. The study population includes both male and female subjects, with an age range that encompasses both adults and adolescents. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial includes a vulnerable population, indicating that special considerations are in place for these individuals. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. The selection process ensures a diverse representation of the affected population, contributing to the robustness of the study findings.

The clinical trial is designed to evaluate the safety and efficacy of KB-0742 in participants with **relapsed or refractory solid tumors** or **non-Hodgkin lymphoma**. This study is structured as a Phase 1, dose escalation and cohort expansion trial. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from the recruitment start date on December 18, 2023, to the anticipated end date on February 28, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be enrolled and randomized into treatment groups. The study will include multiple follow-up visits to monitor safety, tolerability, and any adverse events associated with the investigational product. These visits will also involve assessments of the drug's pharmacokinetics and pharmacodynamics. The end-of-study visit will conclude 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 tolerance to the treatment, but it is anticipated to last throughout the trial's duration unless early termination criteria are met. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. Participants will be closely monitored throughout the trial to ensure their safety and well-being.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment is not available. Additionally, details about drug administration, dosing schedules, and participant compliance monitoring are not included in the source data. As such, no further information can be offered regarding the substances used in this study.

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 18, 2023, with an anticipated end date of February 28, 2026. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. The trial will likely employ standardized methods for measuring and collecting data, which may include validated scales, laboratory tests, or patient-reported outcomes, depending on the investigational product and disease context. The analysis of efficacy data will be conducted in accordance with the trial's protocol, ensuring rigorous and scientifically sound conclusions. The absence of detailed endpoints suggests that the trial's primary focus may be on establishing a foundation for further research in subsequent phases.