Evaluation of HDM201 and Pazopanib in P53 Wild-Type Advanced/Metastatic Soft Tissue Sarcomas

The primary objective of this study is to evaluate the clinical impact of **HDM201** in combination with **Pazopanib** in patients diagnosed with **P53 wild-type advanced/metastatic soft tissue sarcomas**. This investigation is clinically relevant as it aims to assess the potential therapeutic benefits and efficacy of this combination treatment in a patient population with limited options, potentially improving outcomes and providing new insights into treatment strategies for this aggressive form of cancer.

The clinical trial involves participants diagnosed with **advanced/metastatic soft tissue sarcomas**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the impact of a combination therapy involving **HDM201** and **Pazopanib** in patients diagnosed with **advanced/metastatic soft tissue sarcomas**. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thereby minimizing bias. The trial commenced on May 16, 2022, and is projected to conclude by November 15, 2026, encompassing a total duration of approximately four and a half years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed to confirm the suitability of participants for the trial. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor the efficacy and safety of the treatment regimen. These visits will include assessments such as physical examinations, laboratory tests, and imaging studies to evaluate the progression of the disease and any potential side effects of the treatment. The end-of-study visit marks the final assessment, where comprehensive data is collected to analyze the overall outcomes of the trial.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and the overall study timeline. Participants may be subject to early termination from the study if they experience significant adverse effects, demonstrate disease progression that necessitates alternative treatment, or withdraw consent. The trial is conducted in accordance with ethical standards and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

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 through a structured evaluation process. The trial is scheduled to conclude on November 15, 2026, with recruitment having commenced on May 16, 2022. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the study duration. The trial's efficacy assessment will be conducted in accordance with established clinical trial protocols, ensuring rigorous and objective evaluation of the investigational product's therapeutic potential.