Phase 1 Evaluation of JNJ-87890387 in Patients with Advanced Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **JNJ-87890387** in patients with **advanced solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and adverse effects of the investigational drug, which could inform future treatment strategies for patients with these malignancies. No secondary objectives are provided in the available data.

The clinical trial involves a total of **44 participants** diagnosed with **advanced solid tumors**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the investigational product JNJ-87890387 in patients with **advanced solid tumors**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The estimated duration of the trial spans from the recruitment start date on April 1, 2024, to the anticipated end date on September 11, 2026.

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 comprehensive evaluation, including medical history, physical examination, and necessary laboratory tests. Following successful screening, participants will be randomized and commence treatment as per the study protocol. Regular follow-up visits will be scheduled to monitor safety, tolerability, and any potential adverse events. These visits will also include assessments to evaluate the pharmacokinetics and pharmacodynamics of the investigational product.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. This visit will involve a final assessment to gather data on the long-term effects of the treatment. The expected length of participant involvement will vary depending on individual response and tolerability, but it is anticipated to last until the end of the study period. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available in the provided data.

The clinical trial is designed to assess efficacy through a structured evaluation process. As the trial progresses, efficacy will be measured using specific parameters or endpoints, although these have not been explicitly detailed in the provided data. 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 April 1, 2024, with an anticipated end date of September 11, 2026. Throughout the trial, data collection and analysis will adhere to rigorous scientific standards to ensure the reliability and validity of the findings. The absence of specific endpoints or measurement tools in the provided data suggests that these details will be defined in the full trial protocol, which will guide the systematic assessment of efficacy.