Phase 1/1b Evaluation of IAM1363 in Patients with Relapsed/Refractory HER2-Altered Malignancies

The primary objective of this study is to evaluate the safety and tolerability of **IAM1363** in patients with relapsed or refractory malignancies characterized by documented alterations in **human epidermal growth factor receptor 2 (HER2)**. This is clinically relevant as HER2 alterations are associated with aggressive tumor behavior and poor prognosis, necessitating the development of targeted therapies to improve patient outcomes.

The clinical trial involves a total of **136 participants** diagnosed with **relapsed/refractory malignancy** characterized by alterations in the human epidermal growth factor receptor 2 (**HER2**). The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected based on their documented diagnosis of HER2 alterations, without any indication of vulnerability in the population. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the principal inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and efficacy of a novel investigational product in patients with **relapsed/refractory malignancy** characterized by documented alterations in the human epidermal growth factor receptor 2 (**HER2**). This study is a Phase 1/1b trial, which will be conducted as a randomized, double-blind, controlled trial. The estimated duration of the trial spans from October 1, 2025, to July 28, 2027, 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 and diagnostic tests to confirm the presence of HER2 alterations. Following successful screening, participants will be randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' response to the investigational product and to assess any adverse events. These visits will include physical examinations, laboratory tests, and imaging studies as necessary. 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 in the trial is approximately 22 months, contingent upon individual response and tolerance to the treatment. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any medical condition that, in the opinion of the investigator, warrants discontinuation for the safety of the participant. The trial aims to gather critical data on the investigational product's safety profile and therapeutic potential in the targeted patient population.

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 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.

Due to the lack of specific information, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

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 October 1, 2025, with an estimated completion date of July 28, 2027. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize various parameters such as **biomarker** levels or symptom improvement scores to gauge initial efficacy signals. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or patient-reported outcomes at predetermined timepoints. The trial's efficacy assessments will be conducted in accordance with standard clinical trial protocols, ensuring rigorous data collection and analysis to evaluate the investigational product's potential therapeutic effects.