Actively Recruiting
Study of ABBV-637 or ABBV-155 With ERAS-801 for People With Glioblastoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
60
Participants Needed
10
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether the drugs ABBV-637 and ABBV-155 are safe treatments that cause few or mild side effects when given alone or in combination with ERAS-801 in people with recurrent GBM.
CONDITIONS
Official Title
Study of ABBV-637 or ABBV-155 With ERAS-801 for People With Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older at the time of consent signing.
- Patients must have WHO Grade IV Glioblastoma or Gliosarcoma according to WHO 2021 criteria.
- Recurrent patients must have progressive or recurrent disease after radiation therapy with or without chemotherapy.
- Patients must have IDH wild type confirmed by a certified laboratory.
- Patients must have evidence of EGFR gene amplification by a certified laboratory.
- Patients in Cohorts A/B must have measurable disease before surgery per RANO criteria.
- Patients must be able to tolerate MRI scans.
- Patients in Cohorts A/B must have no more than two prior therapy regimens.
- Patients must have recovered from severe toxicity of prior therapies with required waiting periods from previous treatments.
- Patients in Cohorts A/B must be eligible for surgical resection with expected removal of at least 500 mg of tumor tissue without high risk of neurological injury.
- Paraffin embedded tissue must be available from initial surgical resection.
- Patients must have Karnofsky Performance Status of 60% or higher.
- Patients must have adequate organ and marrow function as specified.
- Patients must have an echocardiogram with ejection fraction of 50% or higher and no significant cardiac risk.
- Patients in certain cohorts must have a recent ECG with QTc below 450 msec and no significant abnormalities.
- Women of childbearing potential must have negative pregnancy tests and agree to use contraception during and after study.
- Male participants sexually active with women of childbearing potential must agree to use contraception during and after study.
- Patients must not have active viral hepatitis or HIV infection unless considered cured or controlled.
- Patients must have no concurrent malignancy requiring active therapy.
- Patients must be able to swallow oral medication.
You will not qualify if you...
- Patients receiving other investigational agents.
- Patients with allergic reactions to similar compounds as the study drugs.
- Patients previously treated with EGFR targeting agents unless EGFR alteration persists after such therapy.
- Patients on enzyme-inducing anti-epileptic drugs unless off for 10 days before study.
- Patients with significant blood, kidney, or liver dysfunction.
- Patients with significant intracranial hemorrhage affecting tissue quality.
- Patients with uncontrolled illnesses such as hypertension, active infection, heart failure, unstable angina, arrhythmia, or psychiatric conditions interfering with study compliance.
- Patients with recent significant cardiovascular events or abnormalities increasing risk of QT prolongation.
- Patients with medical or psychiatric conditions making study participation unsuitable.
- Pregnant or breastfeeding women.
- HIV-positive patients on strong CYP3A4 inducers or inhibitors.
- Patients with active or requiring antiviral therapy for liver or biliary disease, except specific exceptions.
- Patients receiving drugs that risk QTc prolongation with QTc ≥ 460 msec.
- Patients who have used moderate or strong CYP3A inhibitors within 10 days before study drug.
- Patients who received live vaccines within 2 weeks before study or expect to need live vaccines during study and 4 weeks after.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Miami (Data collection only)
Miami, Florida, United States, 33136
Actively Recruiting
2
Indiana University (Data Collection Only)
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
10
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
T
Thomas Kaley, MD
CONTACT
I
Ingo Mellinghoff, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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