Actively Recruiting
A Phase 1/2 Trial to Evaluate Safety and Pharmacokinetics of ARV-806 in Adults With KRAS G12D Mutated Advanced Solid Tumors
Led by Arvinas Inc. · Updated on 2026-02-19
159
Participants Needed
14
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential anti-tumor effects of an investigational drug called ARV-806 in adults with advanced cancer that has a specific KRAS G12D mutation. This open-label trial will include participants with various advanced solid tumors in Phase 1 and specifically those with advanced pancreatic ductal adenocarcinoma in Phase 2. ARV-806 is thought to work by breaking down a mutated protein that may help slow or stop tumor growth. This is the first time ARV-806 is being tested in people. The study has two parts. In Part A (Phase 1), small groups of participants will receive increasing doses of ARV-806 given by intravenous infusion weekly or every two weeks to evaluate safety and dosing. In Part B (Phase 2), participants will be assigned to one of up to two dose levels determined from Part A results and will receive ARV-806 on a similar schedule. The drug is administered through a vein and dosing regimens depend on the phase and part of the study. Participants will undergo various assessments including monitoring for side effects and measuring tumor response over approximately two years. Pharmacokinetics of ARV-806 will be studied over about six months to understand how the drug behaves in the body. Safety will be closely watched through laboratory tests and physical exams. Participants must have measurable tumors and meet other health criteria. Follow-up includes evaluation of overall response rate, duration of response, and disease control rate.
CONDITIONS
Brief 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 aged 18 years or older
- Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy
- Evidence of KRAS G12D mutation in tumor tissue or blood
- Prior standard-of-care therapy received or unlikely to benefit from it
- At least 1 measurable lesion
- For pancreatic cancer participants: confirmed diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma with KRAS G12D mutation
- Willing to provide archival tumor tissue or undergo biopsy
- Received at least one prior systemic therapy for pancreatic cancer
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function
- Willingness to follow pregnancy prevention guidance
You will not qualify if you...
- Active brain metastases
- Carcinomatous meningitis
- Uncontrolled hypertension despite optimal treatment
- Prior treatment with KRAS G12D or KRAS G12C targeting therapies including pan-KRAS inhibitors/degraders
- Inability to comply with prohibited treatments
- Recent systemic anticancer therapy or radiation therapy within specified waiting periods
- Clinically relevant abnormalities on standard 12-lead electrocardiogram that may affect safety or study results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months or until discontinuation
Participants receive ARV-806 by intravenous infusion at assigned doses and schedules, either weekly or every 2 weeks, to evaluate safety and pharmacokinetics.
Weekly or biweekly visits depending on assigned dosing schedule
Duration - Approximately 2 years
Participants are monitored for safety and response for up to approximately 2 years after treatment.
Periodic visits during the follow-up period
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.
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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