Evaluation of Safety and Antineoplastic Activity of OATD-02 in Patients with Advanced or Metastatic Solid Tumours: A Multicentre Rollover Study

The primary objective of this study is to evaluate the **safety** and **antineoplastic activity** of OATD-02 in patients with selected advanced and/or metastatic solid tumors, specifically colorectal cancer, ovarian cancer, pancreatic cancer, or renal cell carcinoma. This evaluation is clinically relevant as it aims to determine the therapeutic potential and safety profile of OATD-02 in a population that has completed a prior first-in-human study, potentially offering new treatment avenues for these challenging cancer types.

The clinical trial involves participants diagnosed with **advanced and/or metastatic solid tumors**, specifically colorectal cancer, ovarian cancer, pancreatic cancer, or renal cell carcinoma. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial population was selected to include a vulnerable population, although specific selection criteria have not been disclosed. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits have not been specified in the available data.

The clinical trial is designed as an **open-label**, multicentre, rollover study to evaluate the safety and antineoplastic activity of OATD-02 in patients with selected advanced and/or metastatic solid tumours, including colorectal cancer, ovarian cancer, pancreatic cancer, and renal cell carcinoma. The trial is in Phase 3 and is expected to commence recruitment on August 23, 2023, with an estimated completion date of May 23, 2027. Participants will be involved in the study for its entire duration unless early termination criteria are met. Such criteria may include adverse events, withdrawal of consent, or any condition that, in the opinion of the investigator, warrants discontinuation for the safety of the participant.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on predefined criteria. Following successful screening, participants will undergo regular follow-up visits to monitor safety and efficacy parameters. These visits will include clinical assessments, laboratory tests, and imaging studies as required by the protocol. The end-of-study visit will occur upon completion of the treatment period or upon early termination, where final evaluations will be conducted to assess the overall outcomes of the intervention. The trial's design ensures comprehensive data collection to evaluate the primary and secondary endpoints, although specific endpoints are not detailed in the available 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 treatment. 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 in a Phase 3 study. The trial is scheduled to commence recruitment on August 23, 2023, with an estimated completion date of May 23, 2027. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters at predetermined timepoints throughout the study duration. The trial's design and execution will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.