RecruitingPhase 1NCT06066138

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing


Sponsor

National Cancer Institute (NCI)

Enrollment

30 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects. Objective: To test different doses and timing of atezolizumab for people with cancer. Eligibility: People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug. Design: Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor. Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care. The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later. For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change. Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months. Study treatment may last up to 2 years.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adjusting the dose of atezolizumab (an immunotherapy drug) based on blood drug levels — called therapeutic drug monitoring — can improve how well it works and reduce side effects in patients with advanced cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed locally advanced or metastatic cancer that your doctor believes may respond to atezolizumab (e.g., tumors with high mutation burden, PD-L1 positive cancers, or other cancer types that respond to immune checkpoint therapy) - Your cancer is measurable on scans - You have a good performance status (ECOG 0–2) - Your organ function meets the study's minimum requirements **You may NOT be eligible if...** - Your cancer type is not known to respond to atezolizumab or PD-1/PD-L1 immunotherapy - Your performance status or organ function is too poor for systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab administered via IV at either 1,200 mg q3 weeks, or 1,680 mg q4 weeks for the first 2 doses followed by 840mg q2 weeks or q6 weeks.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06066138


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