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

NCT ID: NCT07023731

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2029-04-02

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 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.

Conditions

KRAS G12D Mutation; Advanced Solid Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1/Part A (Dose Escalation)

Participants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).

Group Type: EXPERIMENTAL

ARV-806

Intervention Type: DRUG

Intravenous infusion at assigned dose and dosing schedule

Phase 2/Part B (Dose Expansion)

Participants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)

Group Type: EXPERIMENTAL

ARV-806

Intervention Type: DRUG

Intravenous infusion at assigned dose and dosing schedule

Interventions

ARV-806

Intravenous infusion at assigned dose and dosing schedule

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arvinas Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Grand Rapids, Michigan, United States

Site Status: RECRUITING

Clinical Trial Site

Huntersville, North Carolina, United States

Site Status: RECRUITING

Clinical Trial Site

San Antonio, Texas, United States

Site Status: RECRUITING

Clinical Trial Site

Fairfax, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Arvinas, Inc.

Role: CONTACT

clinicaltrialsARV-806@arvinas.com

+14752245787

Other Identifiers

2025-521062-10-00

Identifier Type: CTIS

Identifier Source: secondary_id

ARV-806-101

Identifier Type: -

Identifier Source: org_study_id