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A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Final enrollment: 76 participants (planned 159)
    • Eligibility criteria expanded, about 18 words
  2. Primary completion moved earlier from Nov 30, 2027 to Nov 30, 2026
    • Study completion moved earlier from Apr 2, 2029 to Nov 30, 2026
    v6
  3. Primary endpoint(s) modified
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Secondary endpoints revised (16)
    • Site details revised at 14 of 14 sites
    v5
  4. Study sites: 4 to 14v4
  5. Re-verified, no change to tracked fieldsv3
  6. Primary endpoints revised (3)
    • Study sites: 1 to 4
    • Eligibility criteria expanded, about 7 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Arvinas Inc.
3 trials monitored
See all monitored trials
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 8 more diseases
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.
Trial Details
NCT Number NCT07023731
Lead Sponsor Arvinas Inc.
Conditions
(from sponsor)		 KRAS G12D Mutation, Advanced Solid Cancer
Related terms Adenocarcinoma Of Esophagus, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Colonic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Gallbladder Neoplasms, Melanoma, Ovarian Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Thyroid Neoplasms
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov