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ARV-806 for adults with advanced cancer that has the KRAS G12D mutation

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors

Phase1; Phase2 Interventional Arvinas Inc. · NCT07023731

This trial will try ARV-806, an investigational IV drug that breaks down the KRAS G12D mutant protein, in adults with advanced solid tumors carrying the KRAS G12D mutation to see if it is safe and can shrink or slow tumor growth.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment159 (estimated)
Ages18 Years and up
SexAll
SponsorArvinas Inc. Industry-sponsored
Drugs / interventionsradiation
Locations14 sites (Phoenix, Arizona and 13 other locations)
Trial IDNCT07023731 on ClinicalTrials.gov

What this trial studies

ARV-806 is a first-in-human investigational protein degrader given by intravenous infusion that targets the KRAS G12D mutant protein found in some advanced solid tumors. The open-label study has a Phase 1 dose-escalation portion (Part A) to find safe dose levels and a Phase 2 expansion (Part B) that will enroll patients with KRAS G12D-mutant pancreatic ductal adenocarcinoma at selected dose(s). Key measures include safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity such as objective response and progression-free survival. Participants must have confirmed KRAS G12D mutation and generally will have exhausted or be unsuitable for standard treatment options.

Who should consider this trial

Good fit: Adults with unresectable or metastatic solid tumors—and in the Phase 2 portion specifically those with KRAS G12D-mutant pancreatic ductal adenocarcinoma—who have confirmed KRAS G12D mutation and have limited or no remaining standard therapy options are ideal candidates.

Not a fit: Patients without the KRAS G12D mutation, those with disease controllable by standard therapies, or individuals unable to receive intravenous infusions or tolerate experimental treatments are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, ARV-806 could provide a new targeted treatment option that reduces tumor burden or slows progression in patients with KRAS G12D–mutant cancers.

How similar studies have performed: Direct targeting of KRAS G12D with a protein degrader is novel and first-in-human, while separate KRAS G12C inhibitors have shown clinical benefit, so this specific approach remains unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions KRAS G12D MutationAdvanced Solid CancerAdvanced Solid TumorsKRAS G12D Mutated Advanced Solid TumorsKRAS G12D Mutated Pancreatic Ductal AdenocarcinomaPancreatic CancerPDACNon-Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.