OncoMatch/Clinical Trials/NCT07023731
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
Is NCT07023731 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ARV-806 for kras g12d mutation.
Treatment: ARV-806 — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: KRAS g12d
Required: KRAS g12d
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard-of-care therapy — appropriate for their type and stage of disease
Must have received prior standard-of-care (SOC) therapy appropriate for their type and stage of disease and have no other available treatment options with curative intent, or, in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
Must have received: systemic therapy — for PDAC (systemic therapy received in the neoadjuvant or adjuvant setting is allowed)
Must have received at least one prior standard of care systemic therapy for PDAC (systemic therapy received in the neoadjuvant or adjuvant setting is allowed)
Cannot have received: KRAS G12D targeting therapy
Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
Cannot have received: KRAS G12C targeting therapy
Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
Cannot have received: pan-KRAS inhibitor/degrader
Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
Lab requirements
Blood counts
Kidney function
Liver function
Participants with adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clinical Trial Site · Phoenix, Arizona
- Clinical Trial Site · Phoenix, Arizona
- Clinical Trial Site · New Haven, Connecticut
- Clinical Trial Site · Tampa, Florida
- Clinical Trial Site · Indianapolis, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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