Actively Recruiting
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
Led by Arvinas Inc. · Updated on 2026-02-19
159
Participants Needed
14
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with unresectable or metastatic solid tumor malignancy confirmed by histology or cytology
- Evidence of KRAS G12D mutation in tumor tissue or blood (ctDNA)
- Prior standard-of-care therapy received with no available curative options or unlikely benefit from further standard therapy
- At least 1 measurable lesion
- For pancreatic cancer participants: diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma with confirmed KRAS G12D mutation
- Willingness to provide archival tumor tissue or undergo pretreatment biopsy
- At least one prior standard systemic therapy for pancreatic cancer
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function
- Agreement to follow pregnancy prevention guidance
You will not qualify if you...
- Active brain metastases
- Carcinomatous meningitis
- Uncontrolled hypertension despite optimal treatment
- Prior treatment targeting KRAS G12D or KRAS G12C mutations
- Inability to comply with prohibited treatments
- Systemic anticancer therapy or radiation therapy within 2 weeks prior to study treatment (longer interval if antibody-based agent used)
- Clinically relevant abnormalities on 12-lead electrocardiogram affecting safety or study results
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Clinical Trial Site
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
Clinical Trial Site
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Clinical Trial Site
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Clinical Trial Site
Tampa, Florida, United States, 33612
Actively Recruiting
5
Clinical Trial Site
Indianapolis, Indiana, United States, 46250
Not Yet Recruiting
6
Clinical Trial Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Clinical Trial Site
New York, New York, United States, 10032
Actively Recruiting
8
Clinical Trial Site
New York, New York, United States, 10065
Actively Recruiting
9
Clinical Trial Site
Huntersville, North Carolina, United States, 28078
Actively Recruiting
10
Clinical Trial Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Clinical Trial Site
Houston, Texas, United States, 77030-7009
Actively Recruiting
12
Clinical Trial Site
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Clinical Trial Site
Salt Lake City, Utah, United States, 84112
Actively Recruiting
14
Clinical Trial Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Arvinas, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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