Phase 1 Open-Label Study of CTPS1 Inhibitor STP938 in Advanced Solid Tumors and CTPS2 Null Ovarian Cancer

The primary objective of this study is to evaluate the safety and tolerability of the **CTPS1 inhibitor STP938** in adult subjects with advanced **solid tumors**. This is clinically relevant as it aims to determine the potential of STP938 as a therapeutic option for patients with limited treatment alternatives. The study includes a safety expansion specifically targeting advanced **ovarian cancer** cases that are CTPS2 null, which may provide insights into the drug's efficacy in a specific genetic subset of ovarian cancer.

The clinical trial involves a total of **50 participants** diagnosed with **solid tumors and ovarian cancer**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process aimed to encompass a diverse group of individuals to ensure comprehensive data collection and analysis.

The clinical trial is designed as an **open-label**, Phase 1 study to evaluate the safety and efficacy of the CTPS1 inhibitor STP938 in adult subjects with advanced **solid tumors** and a safety expansion in advanced CTPS2 null **ovarian cancer**. The trial is set to commence recruitment on November 25, 2024, and is estimated to conclude by May 30, 2028. Participants will be involved in a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. This is followed by multiple follow-up visits to monitor the participants' response to the treatment and assess any adverse effects. The trial will culminate in an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected duration of participant involvement will vary depending on individual response and the progression of the disease, but it is anticipated to span several months. 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's methodology is structured to ensure rigorous data collection and analysis, contributing to the understanding of the investigational drug's safety profile and therapeutic potential in the specified patient population.

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 involved in the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on November 25, 2024, with an estimated completion date of May 30, 2028. The efficacy of the investigational treatment will be evaluated through a series of predefined parameters, although specific endpoints and methods for measurement and analysis are not detailed in the available data. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that efficacy assessments are conducted systematically and in accordance with established clinical protocols. The trial's design will likely involve the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The results will be analyzed to determine the treatment's impact on the specified medical condition, contributing to the overall understanding of its therapeutic potential.