assignment
Not Yet Recruiting

A Phase 1 Study to Evaluate the Safety and Tolerability of ARV-806 in Adults with KRAS G12D-Mutated Advanced Solid Tumors

Trial ID
2025-521062-10-00
Protocol
ARV-806-101

Trial statistics

location_city
5
research sites
public
2
countries
medical_information
2
diseases
person_search
6
investigators

Diseases & Conditions

Objectives

The primary objective is to evaluate the safety and tolerability of ARV-806 in adult patients diagnosed with advanced solid tumors harboring the KRAS G12D mutation. Assessing these parameters is clinically essential to determine the risk profile and physiological tolerance of the investigational agent within this specific molecularly defined population.

Participants

This clinical trial involves a total of 98 patients. The study population consists of individuals of both male and female genders, aged between 3 and 4 years. The participants are diagnosed with KRAS G12D mutated advanced solid tumors. The sponsor did not provide additional information regarding selection processes, lifestyle considerations, or specific inclusion and exclusion criteria.

Plans and Procedures

This Phase 1 clinical trial is designed to evaluate the safety and tolerability of ARV-806 in adults diagnosed with KRAS G12D mutated advanced solid tumors. The study follows a research methodology to assess the clinical profile of the investigational product. The sequence of procedures begins with a screening visit to determine eligibility based on specific criteria. Following screening, participants proceed through scheduled follow-up visits to monitor safety and tolerability. The process concludes with an end-of-study visit. The total duration of individual involvement is determined by the prescribed study protocol. Early termination from the study may occur if predefined clinical conditions are met.

Treatment

Please provide the source data containing the names, dosages, forms, and administration details of the medications to be described. Once the data is provided, the description will be generated according to the specified technical and structural requirements.

Efficacy

The assessment of efficacy in this Phase 1 clinical trial focuses on patients diagnosed with KRAS G12D mutated advanced solid tumors. Specific parameters for evaluating clinical response and therapeutic impact are not specified.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Italy ItalyNot Yet Recruiting15 Apr 202614
Spain SpainNot Yet Recruiting15 Apr 202637

Sites & Investigators

Conditions Studied in This Trial