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Clinical Trials in the USA / NCT07023731
Active, not recruiting Phase 1/2

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

NCT07023731 · tracked via the Priya Life Science USA tracker
Sponsor
Arvinas Inc
Phase
Phase 1/2
Started
2025-05-29
Last updated
2026-09-16

Condition(s) studied

KRAS G12D MutationAdvanced Solid Cancer

Investigational drug(s) / intervention(s)

ARV-806

ARV-806: Intravenous infusion at assigned dose and dosing schedule

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Part A: * Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND * Must have evidence of KRAS G12D mutation in tumor tissue or blood (circulating tumor deoxyribonucleic acid \[ctDNA\]), AND * 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, AND * Must have at least 1 measurable lesion Part B: * Histological or cytological diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation status confirmed by local testing of tumor tissue using a validated molecular or next-generation sequencing (NGS) testing, AND * Must be willing to provide archival tumor tissue or willing to undergo pretreatment biopsy, AND * 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), AND * Participants must have at least 1 measurable lesion Part A / Part B: * Eastern Cooperative Oncology Group performance status of 0 or 1, * Participants with adequate organ function, * Participants must accept and follow pregnancy prevention guidance. Exclusion Criteria: Part A / Part B: * Active brain metastases * Carcinomatous meningitis * Uncontrolled hypertension despite optimal medical therapy * Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included) * Participants with an inability to comply with listed prohibited treatments * Systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) or radiation therapy (excluding palliative radiation) within 2 weeks prior to the study intervention treatment. If the last immediate anticancer treatment contained an antibody-based agent(s), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) is required prior to receiving the study intervention treatment. * Standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results

Primary outcome measure(s)

  • Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-806 — 28 days from first ARV-806 administration
    Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).
  • Part A (Phase 1): Number of participants with AEs — From the study baseline to at least 28 days after last dose of ARV-806
    AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability
  • Part B (Phase 2): Overall Response Rate (ORR) — Approximately 2 years
    ORR is a parameter measuring the anti-tumor activity of ARV-806. ORR is the percentage of participants for whom the study treatment resulted in a complete response or partial response of the disease under study. It is measured using CT/MRI and RECIST 1.1 criteria per investigator assessment.

Trial sites (14)

FacilityCityRegionStatus
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
Clinical Trial Site Grand Rapids Michigan
Clinical Trial Site New York New York
Clinical Trial Site New York New York
Clinical Trial Site Huntersville North Carolina
Clinical Trial Site Cleveland Ohio
Clinical Trial Site Houston Texas
Clinical Trial Site San Antonio Texas
Clinical Trial Site Salt Lake City Utah
Clinical Trial Site Fairfax Virginia

More Arvinas Inc. trials in the USA

A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Recruiting
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma. Recruiting

Other trials for the same condition

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023731 on ClinicalTrials.gov ↗ ← All trials in the USA