Evaluation of AMG 193 Combined with Additional Therapies in Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers with Homozygous MTAP-Deletion

The study titled "AMG 193 in Combination with Other Therapies in Subjects with Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion – Master Protocol" focuses on evaluating the efficacy and safety of AMG 193 when used in combination with other therapies. The primary objective is to assess the therapeutic potential of AMG 193 in patients with advanced **gastrointestinal tract**, **biliary tract**, or **pancreatic cancers** characterized by homozygous methylthioadenosine phosphorylase (MTAP)-deletion. This is clinically relevant as MTAP-deletion is associated with poor prognosis and limited treatment options, making it crucial to explore new therapeutic avenues for this patient population.

The clinical trial involves a total of **65 participants** diagnosed with **gastrointestinal tract, biliary tract, or pancreatic cancers** characterized by homozygous methylthioadenosine phosphorylase (MTAP)-deletion. The study population is exclusively male, with participants falling within the age categories of 18-64 years. The selection process for the trial population is not specified by the sponsor. Participants are not considered part of a vulnerable population. No specific lifestyle considerations such as diet, physical activity, or habits are provided. The sponsor has not disclosed detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the efficacy and safety of AMG 193 in combination with other therapies in subjects with advanced **gastrointestinal**, biliary tract, or pancreatic cancers characterized by homozygous methylthioadenosine phosphorylase (MTAP)-deletion. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is August 1, 2024, with an anticipated end date of November 1, 2029. The trial will involve multiple study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific inclusion and exclusion criteria. Participants will undergo regular follow-up visits to monitor treatment response and safety, with the frequency and number of visits determined by the study protocol. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted. The expected length of participant involvement will vary depending on individual response to treatment and overall health status. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial aims to provide comprehensive data on the therapeutic potential of AMG 193 in this specific patient population, contributing to the advancement of treatment options for these challenging cancer types.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date is August 1, 2024, with an anticipated end date of November 1, 2029. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically focus on confirming the effectiveness of a treatment, monitoring side effects, and collecting information that will allow the treatment to be used safely. The trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the disease, using scientifically validated methods and tools appropriate for the condition under investigation. The trial's design will ensure that efficacy assessments are conducted at predetermined intervals to provide comprehensive data on the treatment's performance over time.