Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 16, 2026
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Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07023731). This is a study registration, not published results. Lead sponsor: Arvinas Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 76 participants (ACTUAL). Conditions: KRAS G12D Mutation, Advanced Solid Cancer. Interventions: DRUG: ARV-806. Primary outcome measures: Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-806 , 28 days from first ARV-806 administration; Part A (Phase 1): Number of participants with AEs , From the study baseline to at least 28 days after last dose of ARV-806; Part B (Phase 2): Overall Response Rate (ORR) , Approximately 2 years. Brief 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 Kirsten rat sarcoma viral oncogene homolog (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.