Phase I Study of XL092 Monotherapy and Combination Therapy in Advanced Solid Tumors: ccRCC, nccRCC, HR+ BC, mCRPC, and CRC

The primary objective of this study is to evaluate the **safety** and **pharmacokinetics** of XL092, both as a single-agent and in combination therapy, in subjects with inoperable locally advanced or metastatic solid tumors. This is clinically relevant as it aims to determine the tolerability and appropriate dosing of XL092, which could potentially lead to new therapeutic options for patients with limited treatment alternatives. The study focuses on several types of cancer, including advanced clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).

The clinical trial involves a total of **180 participants** diagnosed with various types of cancer, including **advanced clear cell renal cell carcinoma (ccRCC)**, non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC). The study population comprises both male and female subjects, with an age range that includes adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial does not focus on a vulnerable population. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. The selection process aimed to ensure a representative sample of the affected population, although detailed selection methods are not disclosed.

The clinical trial is designed as a **Phase 1** study to evaluate the safety and pharmacokinetics of XL092, both as a single-agent and in combination therapy, in subjects with inoperable locally advanced or metastatic solid tumors. The trial employs a **randomized**, **double-blind**, and **controlled** methodology to ensure the reliability and validity of the results. The estimated duration of the trial spans from March 20, 2019, to November 29, 2024, encompassing both the recruitment and follow-up phases.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve comprehensive medical evaluations to confirm the presence of conditions such as **advanced clear cell renal cell carcinoma**, **non-clear cell renal cell carcinoma**, **hormone receptor-positive breast cancer**, **metastatic castration-resistant prostate cancer**, and **colorectal cancer**. Following successful screening, participants will be enrolled in the trial and randomized to receive either the investigational drug or a control treatment.

Throughout the trial, participants will attend regular follow-up visits to monitor their response to the treatment and to assess any adverse effects. These visits will include physical examinations, laboratory tests, and imaging studies as necessary. The frequency and specific procedures of these visits will be determined by the study protocol and the individual needs of the participants. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to last until the end of the trial period. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial 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 additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment protocols accurately.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was March 20, 2019, with an anticipated end date of November 29, 2024. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the drug's effects, which may include biomarker levels or symptom improvement scores. The methods for measuring and analyzing these parameters are not specified, but Phase 1 trials generally employ validated scales and laboratory tests to ensure accurate and reliable data collection. The trial's efficacy assessments are expected to be conducted at predetermined intervals throughout the study duration, aligning with standard clinical trial practices.