Phase 1 Evaluation of Intratumoral JNJ-87704916 in Patients with Advanced Solid Tumors

The primary objective of this Phase 1 study is to evaluate the safety and tolerability of **JNJ-87704916**, a tumor-targeting virus, when injected directly into tumors in patients with advanced solid tumors. This investigation is clinically relevant as it aims to determine the potential of JNJ-87704916 to provide a novel therapeutic approach for individuals with advanced cancer, where current treatment options may be limited. The study will focus on assessing adverse events and establishing a safe dosage range for future clinical trials.

The clinical trial involves a total of **58 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 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 main objective of the trial or specific inclusion and exclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of JNJ-87704916, a tumor-targeting virus, administered via injection directly into tumors in patients with **advanced solid tumors**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from the recruitment start date on June 28, 2024, to the anticipated end date on November 30, 2029.

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 randomized and receive the investigational product or control. Subsequent follow-up visits will be scheduled to monitor the participants' response to the treatment, assess safety, and collect data on any adverse events. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the study is contingent upon the individual's response to the treatment and the occurrence of any adverse events. 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.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and 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, indicating an initial investigation into the safety and potential efficacy of the intervention. The estimated recruitment start date is June 28, 2024, with an anticipated completion by November 30, 2029. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically focus on safety and dosage, with preliminary efficacy assessments often included. The trial will likely involve regular assessments at predetermined intervals to monitor the intervention's impact on the condition under study. Data collection and analysis will adhere to rigorous scientific standards to ensure the reliability and validity of the findings. The trial's methodology will be aligned with regulatory requirements and best practices in clinical research.