Phase I Study of DS-1103a in Combination Therapy for Advanced HER2-Expressing or HER2-Mutated Solid Tumors

The primary objective of the study titled "DS-1103a Combination Therapy First-in-human (FIH) Study" is to evaluate the safety and tolerability of DS-1103a in patients with **advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors**. This is clinically relevant as it aims to determine the potential of DS-1103a as a therapeutic option for patients with these specific types of tumors, which are often associated with poor prognosis and limited treatment options.

The clinical trial involves a total of **62 participants** diagnosed with **advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. The selection process and any additional criteria for inclusion or exclusion are not detailed by the sponsor.

The clinical trial is designed to evaluate the safety and efficacy of a combination therapy in patients with **advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated 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, and pharmacokinetics of the investigational treatment. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is October 30, 2023, with an anticipated end date of October 1, 2026, indicating a total trial duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This initial visit will involve a comprehensive assessment, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either the investigational therapy or a control. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess treatment response, and record any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study.

The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes and any long-term effects of the therapy. The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. 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. Participants' safety and well-being are prioritized throughout the trial, with continuous monitoring and appropriate measures in place to address any concerns that arise during the study.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage, with preliminary efficacy assessments. The trial is scheduled to commence recruitment on October 30, 2023, and is estimated to conclude by October 1, 2026. Although specific efficacy endpoints and methods for measurement are not detailed, Phase 1 trials typically involve initial assessments of therapeutic effects, which may include biomarker analysis or preliminary symptom improvement evaluations. The data collection and analysis will adhere to standard clinical trial protocols, ensuring rigorous and systematic evaluation of the investigational product's efficacy. The trial's design will likely incorporate validated tools and instruments appropriate for the condition under investigation, although these are not specified in the available data.