New drug combo targets brain tumor fuel in early trial
NCT ID NCT03343197
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested two experimental drugs, AG-120 and AG-881, in 49 adults with a recurrent, slow-growing brain tumor (low grade glioma) that has a specific IDH1 gene mutation. The goal was to see if these drugs could lower a substance called 2-HG in the tumor tissue before surgery. The study focused on safety and how the drugs work in the body, not on curing the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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49 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be ≥18 years of age. 2. Have histologically or cytologically confirmed recurrent Grade 2 or 3 LGG (oligodendroglioma or astrocytoma according to World Health Organization 2016 classification). 3. Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing. 4. Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR, with at least 1 non-enhancing tumor measuring 1×1×1 cm. 5. Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate). 6. Have KPS of ≥60% 7. Have expected survival of ≥12 months. Exclusion Criteria: 1. Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent \<14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ≥5 half-lives of the investigational agent has elapsed. 2. Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.) 3. Have received any prior treatment with an IDH inhibitor. 4. Have received any prior treatment with bevacizumab (Avastin).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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United States, California
Los Angeles, California, 90024, United States
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United States, California
San Francisco, California, 94143, United States
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United States, Massachusetts
Boston, Massachusetts, 02215, United States
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United States, New York
New York, New York, 10065, United States
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United States, North Carolina
Durham, North Carolina, 27710, United States
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United States, Texas
Dallas, Texas, 75390, United States
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