Phase 1 Study of PF-07985045 in Patients with KRAS Mutated Advanced Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **PF-07985045** in participants with **KRAS mutated advanced solid tumors**. This is clinically relevant as it aims to determine the potential of PF-07985045 as a therapeutic option for patients with these specific genetic mutations, which are often associated with poor prognosis and limited treatment options. The study will provide insights into the drug's safety profile, which is crucial for further clinical development.

The clinical trial involves a total of **169 participants** diagnosed with **KRAS mutated advanced solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria. The selection process aimed to encompass a diverse group within the specified age and health condition parameters.

The clinical trial is a **Phase 1** study designed to evaluate the investigational product PF-07985045 in participants with **KRAS mutated advanced solid tumors**. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The estimated duration of the trial spans from September 2025, with the commencement of recruitment, to June 2028, marking the anticipated end date. Participants will be involved in the study for a period that aligns with the trial's overall timeline, subject to individual response and tolerability.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following successful screening, participants will undergo a series of follow-up visits at regular intervals. These visits are designed to monitor the safety and efficacy of the investigational product, collect data on pharmacokinetics and pharmacodynamics, and assess any adverse events. The end-of-study visit marks the conclusion of a participant's involvement, where final assessments are conducted to gather comprehensive data on the long-term effects of the treatment.

Participant involvement is expected to last throughout the trial duration unless specific conditions necessitate early termination. Such conditions may include the occurrence of significant adverse events, lack of therapeutic benefit, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants. The study's design and procedures are meticulously planned to achieve the primary objective of evaluating the investigational product's safety profile and preliminary efficacy in the target population.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the study may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, it is not possible to provide further details on the **active substances** involved in the trial, their origin, or the product's authorization status. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

The clinical trial is designed to assess the efficacy of the investigational product through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage determination, with preliminary efficacy assessments. The trial is scheduled to commence recruitment on September 1, 2025, and is estimated to conclude by June 1, 2028. Although specific efficacy endpoints are not detailed, typical Phase 1 trials may involve the collection of data related to pharmacokinetics and pharmacodynamics, as well as initial observations of therapeutic effects. The efficacy assessments will likely involve the use of validated scales and laboratory tests to measure relevant biomarkers or clinical outcomes. Data collection will be systematically conducted at predetermined intervals throughout the trial duration to ensure comprehensive analysis. The results will be analyzed to determine the investigational product's potential efficacy, guiding further clinical development in subsequent trial phases.