A Study to Evaluate ARV-806 in 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
2 other identifiers
interventional
159
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2025
CompletedFirst Submitted
Initial submission to the registry
June 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 2, 2029
February 19, 2026
February 1, 2026
2.5 years
June 9, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part A (Phase 1): Number of dose-limiting toxicities of ARV-806
Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).
28 days from first ARV-806 administration
Part A (Phase 1): Number of participants with AEs
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
From the study baseline to at least 28 days after last dose of ARV-806
Part B (Phase 2): Overall Response Rate (ORR)
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.
Approximately 2 years
Secondary Outcomes (16)
Pharmacokinetics (PK) of ARV-806 (Part A): Area under the plasma or blood concentration-time profile during a dosing interval (AUC0-tau)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
PK of ARV-806 (Part A): Area under the plasma or blood concentration time profile from time zero to the time of the last quantifiable concentration (Clast) (AUC0-last)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806
PK of ARV-806 (Part A): Maximum plasma or blood concentration (Cmax)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
PK of ARV-806 (Part A): Minimum observed concentration (Cmin)
Timeframe: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
PK of ARV-806 (Part A): Plasma or blood clearance (CL)
At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806.
- +11 more secondary outcomes
Study Arms (2)
Phase 1/Part A (Dose Escalation)
EXPERIMENTALParticipants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).
Phase 2/Part B (Dose Expansion)
EXPERIMENTALParticipants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)
Interventions
Intravenous infusion at assigned dose and dosing schedule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arvinas Inc.lead
Study Sites (14)
Clinical Trial Site
Phoenix, Arizona, 85004, United States
Clinical Trial Site
Phoenix, Arizona, 85054, United States
Clinical Trial Site
New Haven, Connecticut, 06510, United States
Clinical Trial Site
Tampa, Florida, 33612, United States
Clinical Trial Site
Indianapolis, Indiana, 46250, United States
Clinical Trial Site
Grand Rapids, Michigan, 49546, United States
Clinical Trial Site
New York, New York, 10032, United States
Clinical Trial Site
New York, New York, 10065, United States
Clinical Trial Site
Huntersville, North Carolina, 28078, United States
Clinical Trial Site
Cleveland, Ohio, 44106, United States
Clinical Trial Site
Houston, Texas, 77030-7009, United States
Clinical Trial Site
San Antonio, Texas, 78229, United States
Clinical Trial Site
Salt Lake City, Utah, 84112, United States
Clinical Trial Site
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2025
First Posted
June 17, 2025
Study Start
May 29, 2025
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
April 2, 2029
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share