Evaluation of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Patients with Advanced Solid Tumors

The primary objective of the study titled "Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors" is to evaluate the efficacy and safety of the investigational drug **Anti-CEACAM5 ADC M9140** in patients with **advanced solid tumors**. This is clinically relevant as it aims to address the therapeutic needs of patients with these challenging malignancies, potentially offering a new treatment option. The study does not specify any secondary objectives.

The clinical trial involves a total of **136 participants** diagnosed with **advanced solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to ensure a diverse representation of the general population, including vulnerable groups. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective or specific inclusion and exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and efficacy of **Anti-CEACAM5 ADC M9140** in patients with **advanced solid tumors**. This is a Phase 1 trial, which is typically the first stage of testing in human subjects and focuses on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational product. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from the recruitment start date on September 1, 2022, to the estimated end date on November 29, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a control. Regular follow-up visits will be scheduled to monitor the participants' health, assess the investigational product's effects, and collect data on any adverse events. The end-of-study visit will conclude 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 throughout the trial's duration unless early termination is warranted. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration 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 September 1, 2022, with an estimated completion date of November 29, 2026. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize a range of parameters such as biomarker levels, symptom improvement scores, or other relevant clinical measures to evaluate efficacy. These parameters are typically measured at predefined intervals throughout the trial to monitor changes over time. The data collected will be analyzed using appropriate statistical methods to determine the efficacy of the investigational product. The trial will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.