Dose-Escalation Study of XmAb24306 Alone and with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **XmAb24306** as a single agent and in combination with **Atezolizumab** in patients with **locally advanced or metastatic solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and adverse effects of these treatments, which could inform future therapeutic strategies for managing advanced solid tumors.

The clinical trial involves a total of **176 participants** diagnosed with **locally advanced or metastatic solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to ensure a diverse representation of the general population, including vulnerable groups. 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 or specific inclusion and exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and efficacy of **XmAb24306** as a single agent and in combination with **Atezolizumab** in patients with **locally advanced or metastatic solid tumors**. This is a Phase 1, open-label, dose-escalation study. The trial is expected to commence recruitment on June 20, 2021, and is estimated to conclude by September 14, 2025. The study employs a randomized, controlled design to ensure the reliability of the results. Participants will be involved in the trial for a duration that aligns with the study's objectives and dosing schedule, with specific timelines determined by individual response and tolerance to the treatment.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will undergo a series of follow-up visits, which are scheduled to monitor the safety, tolerability, and preliminary efficacy of the investigational treatment. These visits will include clinical assessments, laboratory tests, and imaging studies as required. The end-of-study visit will occur after the final treatment cycle, where comprehensive evaluations will be conducted to gather data on the long-term effects of the treatment.

Participant involvement is expected to last until the completion of the treatment cycles, with the possibility of early termination if adverse events occur or if the participant withdraws consent. Other conditions for early termination include non-compliance with the study protocol or if the investigator determines that continued participation is not in the participant's best interest. The study is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 the administration of other medicinal products or their role in the trial.

Furthermore, the documentation lacks information on the **participant compliance monitoring** procedures, dosing schedules, and any additional relevant information about drug administration. The absence of these details limits the ability to provide a comprehensive description of the treatments used in this 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 assessment of the investigational product's safety and potential efficacy. The trial is scheduled to commence recruitment on June 20, 2021, with an estimated completion date of September 14, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 1 trials typically focus on safety and pharmacokinetics, with preliminary efficacy data being collected. The trial will likely involve regular assessments at predetermined intervals to monitor the investigational product's effects. Data collection methods and analysis plans are expected to adhere to standard clinical trial protocols, ensuring the reliability and validity of the findings. The trial's design will incorporate appropriate tools and instruments to measure efficacy, although these are not specified in the available data.