Phase 1 Evaluation of ORIC-944 in Patients with Metastatic Prostate Cancer

The primary objective of this study is to evaluate the safety and tolerability of **ORIC-944** in patients with metastatic **prostate cancer**. This is clinically relevant as it aims to determine the potential of ORIC-944 as a therapeutic option for individuals with advanced stages of this prevalent malignancy, which could lead to improved management and outcomes for patients suffering from this condition.

The clinical trial involves a total of **202 participants** diagnosed with **prostate cancer**. The study population consists exclusively of male subjects, with an age range that includes both middle-aged and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial does not include a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits were not specified. The selection process aimed to ensure a representative sample of the target demographic, focusing on individuals who meet the general health status requirements for participation in a prostate cancer study.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of a new investigational drug in patients with **metastatic prostate cancer**. The trial is structured as a randomized, double-blind, and controlled study, ensuring that neither the participants nor the researchers know who is receiving the investigational drug or the placebo, thus minimizing bias. The estimated duration of the trial is from March 5, 2025, to April 28, 2028, allowing for comprehensive data collection and analysis over this period.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for determining whether potential participants meet the necessary conditions to partake in the study. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor their health status, assess the drug's effects, and ensure adherence to the study protocol. These visits are integral to collecting consistent data and ensuring participant safety throughout the trial. The study will conclude with an end-of-study visit, where final assessments are conducted, and participants are debriefed on their involvement in the trial.

The expected length of participant involvement is aligned with the overall trial duration, although individual participation may vary based on specific study requirements or personal health conditions. Participants may be subject to early termination from the study if they experience adverse effects, fail to comply with the study protocol, or choose to withdraw consent. Such conditions are in place to prioritize participant safety and maintain the integrity of the trial data.

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 trial 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.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on March 5, 2025, with an estimated completion date of April 28, 2028. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize various parameters such as biomarker levels, symptom improvement scores, or patient-reported outcomes to gather initial efficacy data. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or other standardized instruments. The trial will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy data collected.