Actively Recruiting
A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Led by National Cancer Institute (NCI) · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a drug called atezolizumab, a type of monoclonal antibody immune checkpoint inhibitor used in cancer treatment. The study aims to find out if lower doses of atezolizumab can provide the same benefit while reducing side effects for people with locally advanced or metastatic cancer. This is a phase I feasibility study focused on therapeutic drug monitoring-based dosing to maintain effective drug levels. Participants will receive atezolizumab through a vein in the arm. The first two doses will follow the FDA-approved dosing schedule, which could be 1,200 mg every 3 weeks, 1,680 mg every 4 weeks, or 840 mg every 2 weeks, as chosen by their doctor. Before the third dose, drug levels in the blood will be checked to adjust timing, and from the third dose onward, the dose will switch to 840 mg with timing personalized for each participant. During the study, blood tests and imaging scans will be performed, and tumor tissue samples collected. Drug levels will be monitored before each dose for the first 16 weeks, then every three months thereafter. Treatment may last up to two years. Researchers will assess the feasibility of maintaining target drug levels while reducing exposure and monitor dosing frequency needed to keep effective drug concentrations.
CONDITIONS
Brief Title
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with locally advanced or metastatic pathologically confirmed cancer eligible for atezolizumab treatment alone or with other FDA-approved drugs
- Age 18 years or older
- Measurable disease according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including ANC \u22651,200/microliter, hemoglobin >9.0 g/dL, platelets \u226575,000/microliter, total bilirubin \u22641.5 mg/dL (or <3.0 mg/dL for Gilbert's Syndrome), AST/ALT \u22642.5 times upper limit
- Creatinine clearance \u226530 mL/min/1.73 m2
- Serum albumin >3 g/dL
- Willingness to use effective contraception during treatment and for 5 months after last dose if of child-bearing potential
- Willingness to discontinue nursing during treatment and for 5 months after last dose
- Participants with HIV, HBV, or HCV infection must have undetectable viral load on appropriate therapy
- Participants with treated brain metastases must have no evidence of progression
- Prior or concurrent malignancies allowed if not interfering with study safety or efficacy
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of investigational agents for cancer treatment within 28 days prior to study start
- Use of immunostimulatory or immunosuppressive agents including IFN-alpha, IFN-gamma, IL-2, or herbal medicines within 1 month prior (except low-dose systemic steroids or local steroids)
- Prior treatment with CD137 agonists
- Prior immune checkpoint therapies including atezolizumab within 28 days prior
- History or risk of autoimmune disease except controlled hypothyroidism, controlled type 1 diabetes, or limited controlled dermatologic autoimmune conditions
- Persisting toxicity > Grade 1 from prior therapy (except alopecia or sensory neuropathy Grade \u22642)
- Prior allogeneic bone marrow or solid organ transplantation
- History of severe allergic reactions to chimeric or humanized antibodies
- Known hypersensitivity to components of atezolizumab
- Live attenuated vaccine within 4 weeks prior to treatment
- Active tuberculosis
- History of certain lung diseases or active pneumonitis
- Significant cardiovascular disease within 3 months prior
- Pregnancy
- Uncontrolled illness or conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive atezolizumab starting with the FDA approved dose for the first two doses, followed by dosing adjustments based on therapeutic drug monitoring to maintain target drug levels during the first 16 weeks.
Visits prior to each dose for blood draws and drug administration every 2 to 4 weeks
Duration - Up to 2 years after initial treatment
After 16 weeks of treatment, participants continue monitoring and dose adjustments every 3 months to maintain target drug levels until 2 years.
Visits every 3 months for drug level monitoring and possible dose adjustments
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
J
James L Gulley, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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