Evaluation of Tuvusertib (M1774) Combined with DNA Damage Response or Immune Checkpoint Inhibitors in Metastatic or Locally Advanced Unresectable Solid Tumors

The primary objective of this study is to evaluate the efficacy and safety of **tuvusertib** (M1774) when used in combination with DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in patients with **metastatic or locally advanced unresectable solid tumors**. This is clinically relevant as it aims to explore potential therapeutic options for patients with advanced-stage tumors, where current treatment options may be limited or ineffective.

The clinical trial involves a total of **73 participants** diagnosed with **metastatic or locally advanced unresectable solid tumors**. The study population includes both male and female subjects, encompassing an age range that includes adults and older adults. Participants were selected to include a vulnerable population, although specific selection criteria were not disclosed by the sponsor. 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 the principal inclusion criteria.

The clinical trial is designed to evaluate the efficacy and safety of **tuvusertib** in combination with DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in patients with **metastatic or locally advanced unresectable solid tumors**. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date was July 29, 2022, with an anticipated end date of March 31, 2026. The trial involves a series of structured study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants who meet the inclusion criteria will be randomized to receive either the investigational treatment or a control. Follow-up visits will be scheduled at regular intervals to monitor the participants' response to treatment and to assess any adverse events. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the primary and secondary endpoints of the trial.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Participants may be withdrawn from the study early if they experience significant adverse effects, if the disease progresses, or if they withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants. The study aims to provide valuable data on the potential benefits and risks associated with the combination therapy in the specified patient population.

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 in a Phase 3 study. The trial is scheduled to commence recruitment on July 29, 2022, with an estimated completion date of March 31, 2026. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The methodology for measuring and analyzing efficacy will be aligned with the trial's objectives, ensuring that the results are scientifically valid and reliable. The trial's design will incorporate appropriate tools and instruments to facilitate accurate efficacy assessments, although specific tools are not mentioned in the provided information.