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A Study of ARV-806 for Advanced Cancer with KRAS G12D Mutation

This study is testing a new investigational drug called ARV-806 in adults with advanced solid cancers that have a specific genetic change called a KRAS G12D mutation. Researchers believe ARV-806 works by breaking down a mutated protein that helps tumors grow. This is the first time ARV-806 will be given to people. You would receive ARV-806 through an intravenous (IV) infusion, meaning it goes directly into your vein. The study aims to understand how safe ARV-806 is and if it can shrink tumors or stop them from growing. To join, you must have advanced solid cancer with the KRAS G12D mutation and have already tried standard treatments. The study plans to enroll about 159 participants.

Study design
This is an open-label study, meaning both you and the study staff will know you are receiving ARV-806. It is designed to evaluate safety and potential anti-tumor activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for at least 28 days after your last dose of ARV-806. Overall response to treatment will be measured for approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07023731

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Arvinas Inc.
~159 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:ARV-806

At a glance

Recruiting sites
0 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-806
Measured over 28 days from first ARV-806 administration
+2 more outcomes measured

Conditions

KRAS G12D Mutation
Advanced Solid Cancer

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NCT07023731

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Trial Site

    Phoenix, Arizonano site contact published

  • Clinical Trial Site

    Phoenix, Arizonano site contact published

  • Clinical Trial Site

    New Haven, Connecticutno site contact published

  • Clinical Trial Site

    Tampa, Floridano site contact published

  • Clinical Trial Site

    Indianapolis, Indianano site contact published

  • Clinical Trial Site

    Grand Rapids, Michiganno site contact published

  • Clinical Trial Site

    New York, New Yorkno site contact published

  • Clinical Trial Site

    New York, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
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
Eastern Cooperative Oncology Group performance status of 0 or 1,
Participants with adequate organ function,
Participants must accept and follow pregnancy prevention guidance.

Exclusion

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

What this trial measures

  • Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-80628 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 AEsFrom 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.