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NCT07023731 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
A Phase 1 study of Advanced Solid Cancer and KRAS G12D Mutation, sponsored by Arvinas.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 159
- Enrollment target
- 14
- Study locations
NCT07023731: Recruiting Phase 1 study of Advanced Solid Cancer and KRAS G12D Mutation, sponsored by Arvinas.
NCT07023731 is a Phase 1 study of Advanced Solid Cancer and KRAS G12D Mutation that is actively recruiting participants, run by Arvinas. The registered enrollment target is 159 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (165% higher). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07023731, a Phase 1 study of Advanced Solid Cancer and KRAS G12D Mutation, is actively recruiting participants, sponsored by Arvinas.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 159 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806. Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is called intravenous (IV) infusion. This study will include 2 parts. In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included. In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.
Primary Outcome
Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).
Conditions Studied
Interventions
- DRUG ARV-806
Study Locations (14)
Arizona
- Clinical Trial Site - Phoenix
- Clinical Trial Site - Phoenix
New York
- Clinical Trial Site - New York
- Clinical Trial Site - New York
Texas
- Clinical Trial Site - Houston
- Clinical Trial Site - San Antonio
Connecticut
- Clinical Trial Site - New Haven
Florida
- Clinical Trial Site - Tampa
Indiana
- Clinical Trial Site - Indianapolis
Michigan
- Clinical Trial Site - Grand Rapids
North Carolina
- Clinical Trial Site - Huntersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2025-05-29 |
| Est. Completion | 2029-04-02 |
| Phase | Phase 1 |
What NCT07023731 shows while recruiting
NCT07023731 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (165% higher).
The record links to 2 conditions, with Advanced Solid Cancer appearing as the primary indexed condition, and to 1 intervention - of which ARV-806 is the first listed.
NCT07023731 lists 14 locations in 11 states (Arizona, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT07023731 about?
NCT07023731 is a clinical study titled "A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation". This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive A...
What is the current status of trial NCT07023731?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 159 participants. The study started on 2025-05-29. Estimated completion is 2029-04-02.
What conditions does trial NCT07023731 study?
This clinical trial studies the following conditions: Advanced Solid Cancer, KRAS G12D Mutation.
What interventions are being tested in trial NCT07023731?
The interventions under investigation include: ARV-806 (DRUG).
Who is sponsoring clinical trial NCT07023731?
This trial is sponsored by Arvinas, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07023731 being conducted?
This trial has 14 study locations across Arizona, Connecticut, Florida, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07023731's enrollment target sits among peer trials
159 347th of 2000 higher than 1,653 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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