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
- Sponsor
- Arvinas Operations Inc.
Trial statistics
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
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 | Not Yet Recruiting | 15 Apr 2026 | 14 |
Spain | Not Yet Recruiting | 15 Apr 2026 | 37 |


