Phase 1 Study of Subcutaneous Trastuzumab Deruxtecan in Patients with Advanced Solid Tumors

The primary objective of this Phase 1 trial is to evaluate the safety and pharmacokinetics of subcutaneous trastuzumab deruxtecan in patients with advanced solid tumors. This investigation is clinically relevant for determining the tolerability and systemic exposure profiles of this subcutaneous administration route compared to intravenous methods. Secondary objectives include the assessment of efficacy through tumor response measurements and the monitoring of safety markers to identify potential adverse events associated with the treatment regimen.

This clinical trial involves a total of 51 patients. The study population consists of both male and female individuals. The participants are categorized within the vulnerable population group. The age range for the subjects corresponds to the specific clinical classifications of 3 and 4. All participants are diagnosed with advanced solid tumor.

This Phase 1 clinical trial evaluates the efficacy and safety of subcutaneous trastuzumab deruxtecan in patients diagnosed with advanced solid tumor. The study design involves a sequence of clinical assessments starting with a screening visit to determine eligibility. Following enrollment, participants undergo scheduled follow-up visits to monitor clinical response and safety parameters. The process concludes with an end-of-study visit. The total duration of participant involvement is determined by individual clinical progression and protocol requirements. Early termination from the study may occur due to specific clinical criteria or safety concerns as defined by the protocol.

The assessment of efficacy in this phase 3 clinical trial focuses on the management of advanced solid tumor. Specific parameters for evaluating therapeutic response and clinical outcomes are to be determined through standardized evaluation protocols.