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GlioblastomaPhase 1NCT06934889

Study of ABBV-637 or ABBV-155 With ERAS-801 for People With Glioblastoma

A Phase 1 study testing ERAS-801, ABBV-637 and ABBV-155 in people with Glioblastoma and Gliosarcoma, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Gliosarcoma
What is being tested?
ERAS-801, ABBV-637 and ABBV-155
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
11 sitesUnited States
Study dates
7 Apr 2025to Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be 18 years of age or older at the time of consent signing.
  • All Patients must have WHO Grade IV Glioblastoma/Gliosarcoma using WHO 2021 criteria and include the diagnosis of molecular GBM, recurrent patients must be progressive or recurrent following radiation therapy +/- chemotherapy
  • Patients must be IDH wild type by CLIA-certified laboratory assay available at time of consent.
  • Patients must have evidence of EGFR gene amplification by CLIA-certified laboratory assay at time of consent.
  • Patients must have measurable disease as per RANO criteria pre-operatively (there is no requirement for post-operative disease to be present or absent). [cohort A/B only]
  • Patients must be able to tolerate MRIs
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  • Patients may have no more than 2 prior therapy regimens. [cohort A/B only]
  • Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:
  • 12 weeks from the completion of radiation
  • 6 weeks from a nitrosourea chemotherapy
  • 3 weeks from a non-nitrosourea chemotherapy
  • 4 weeks from any investigational (not FDA-approved) agents
  • 6 months from the last treatment with bevacizumab
  • 2 weeks or 5 half-lives from administration of a non-cytotoxic, Chemotherapies other than bevacizumab, whichever is shorter
  • Patients must be undergoing surgery that is clinically indicated as determined by their care providers. [cohort A/B only] Patients must be eligible for surgical resection according to the following criteria:
  • Expectation that the surgeon is able to resect at least 500 mg of tumor from enhancing tumor with low risk of inducing neurological injury.
  • Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment). The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5µm thick).
  • Patients must have a Karnofsky Performance Status (KPS) ≥60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
  • Patients must have the following organ and marrow function:
  • Absolute neutrophil count >1,200/mcL
  • Platelets >100,000/mcL
  • Hemoglobin > 9 g/dL .
  • Total bilirubin ≤ institutional upper limit of normal, or ≤ 3.0 mg/dL for subjects with Gilbert's syndrome
  • AST (SGOT) and ALT (SGPT) ≤ 3 × institutional upper limit of normal
  • Creatinine ≤ institutional upper limit of normal OR Creatinine clearance >60 ml/min/1.73m2 for patients with creatinine levels above institutional normal
  • APTT/PTT ≤ 1.5 x institutional upper limit of normal
  • Echocardiogram with ejection fraction ≥ 50% and no other clinically significant finding that, in the opinion of the investigator, would increase the subject's susceptibility to cardiac toxicity.
  • If ECHO cannot be performed for structural or safety reasons, a MUGA may be obtained instead after discussion with treating investigator.
  • Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QT interval corrected for heart rate (QTc) < 450 msec (using Fridericia's correction), and no clinically significant abnormalities. (Cohorts A, B, E \& F only)
  • Women of childbearing potential must have a negative serum pregnancy test prior to study entry. Women of childbearing potential and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of treatment administration. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A negative serum pregnancy test for all female subjects (except postmenopausal) at the screening visit and a negative urine pregnancy test for all female subjects (except postmenopausal) at baseline before the first dose of study drug.
  • If female, subject must be either postmenopausal, OR permanently surgically sterile OR, for women of childbearing potential, practicing at least 1 protocol-specified method of birth control that is effective from study Day 1 through at least 4 months after the last dose of study drug.
  • If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree from study Day 1 through 4 months after the last dose of study drug to practice the protocol-specified contraception.
  • If female, subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study while receiving study drug and for at least 4 months after the last dose of study drug.
  • If male, subject must not be considering fathering a child or donating sperm during the study or for 4 months after the last dose of study drug.
  • No known active viral hepatitis infection (including hepatitis B and C) or human immunodeficiency virus (HIV) with the following exceptions:
  • Subjects with a history of hepatitis B that is considered cured may be enrolled at the discretion of the treating investigator.
  • Subjects with a history of hepatitis C that is considered cured with definitive therapy may be enrolled at the discretion of the treating investigator.
  • Subjects with HIV and undetectable viral load, so long as ongoing antiretroviral therapy does not pose risk of adverse drug-drug interactions, at the discretion of the treating investigator.
  • Patients must have no concurrent malignancy that requires active therapy.
  • Patients must be able to swallow medication by mouth, either tablets or dispersed in solution.

Who cannot join

  • Patients may not be receiving any other investigational agents.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the investigational agents are ineligible.
  • Patients with prior therapy with EGFR targeting agents are ineligible because treatment with EGFR kinase inhibitors or other EGFR-targeted agents has the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of the investigational regimen. Patients would only be eligible if surgery on a recurrence after the EGFR-targeted therapy confirmed persistence of an EGFR alteration.
  • Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of study drug(s).
  • Patients must not have evidence of significant hematologic, renal, or hepatic dysfunctioPatients must not have evidence of significant intracranial hemorrhage (For example, in the recurrent setting, circumstances where the intracranial hemorrhage would obscure the amount and quality of tissue obtained at the time of the on-treatment surgery).
  • Patients with uncontrolled intercurrent illness including, but not limited to, hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements, are ineligible.
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  • Participants with clinically significant cardiovascular disease including, but not limited to:
  • No recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, second- or third-degree heart block, PR-interval > 250 ms.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, or any concomitant medication know to prolong the QT interval.
  • No history of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug
  • Pregnant women are excluded from this study because the investigational regimens have potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on this study.
  • HIV-positive patients on strong CYP3A4 inducers or inhibitors are ineligible because of the potential for pharmacokinetic interactions.
  • Patients who have acute or currently active/requiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment).
  • Patients receiving P-gp inhibitors/P-gp substrates with narrow therapeutic index are ineligible.
  • Patients who are receiving a drug that has a risk of QTc prolongation with known risk of if QTc is ≥ 460 msec. are ineligible. (Temozolomide is allowed for cohorts C,D, E and F)
  • Subject must not have systemically used known moderate or strong cytochrome P450 (CYP)3A inhibitors within 10 days before the first dose of study drug and throughout the study. Subjects may be approved to start within 7 days of discontinuation of known moderate or strong herbal supplements cytochrome P450 (CYP)3A inhibitors with PI approval. Note: Herbal supplements; oregano, black seed, dandelion, and soursop have been approved for 7 day washout.
  • Subject must not have received any live vaccine within 2 weeks before the first dose of study drug, or be expected to need a live vaccination during study participation including at least 4 weeks after the last dose of study drug.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Kaley, MD contact

212-639-5122

kaleyt@mskcc.org

Ingo Mellinghoff, MD contact

646-888-2766

11 sites in 1 country

United States11 sites, 11 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Thomas Kaley, MD, 212-639-5122

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Alissa Thomas, MD, 802-847-8400

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Thomas Kaley, MD, 212-639-5122

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

    Thomas Kaley, MD, 212-639-5122

    Recruiting

  • Indiana University (Data Collection Only)

    Indianapolis, Indiana, 46202

    Kathryn Nevel, MD, 317-948-5450

    Recruiting

  • University of California, Los Angeles (Data Collection Only)

    Los Angeles, California, 90095

    Phioanh Nghiemphu, MD, 310-206-6909

    Recruiting

  • University of Miami (Data collection only)

    Miami, Florida, 33136

    Macarena De La Fuente, MD

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Thomas Kaley, MD, 212-639-5122

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Thomas Kaley, MD, 212-639-5122

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Thomas Kaley, MD, 212-639-5122

    Ingo Mellinghoff, MD, 646-888-2766

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Rockville Centre, New York, 11553

    Thomas Kaley, MD, 212-639-5122

    Recruiting

Other trials in United States

About this study

Official title: Phase Ib Trial of ABBV-637 or ABBV-155 in Combination With ERAS-801 for Glioblastoma With Amplification of the Epidermal Growth Factor Receptor

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.

Read the detailed description

Stage 1 will run first, during which patients will be randomized to either Cohort A or B if recurrent GBM, and Cohort C or D if newly diagnosed. After these 4 cohorts are complete, and if the combinations have been safe and tolerable, the combination will be further evaluated in Stage 2.

Being tested
ERAS-801, ABBV-637, ABBV-155, Temozolomide, Radiotherapy
Keywords
WHO grade IV, ABBV-637, ABBV-155, ERAS-801, 24-409
Medical subject headings
Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS-801Drug

    will be administered orally at the assigned dose once daily starting on Cycle 1 Day 1.

  • ABBV-637Drug

    will be administered intravenously over one hour (+/- 10 min) once every 28 days on the first day of the new cycle.

  • ABBV-155Drug

    will be administered intravenously over at least 30 minutes once every 21 days on the first day of the new cycle.

  • TemozolomideDrug

    Temozolomide will be continued for 6 cycles after radiation.

  • RadiotherapyRadiation

    will be given as per standard of care radiation for GBM

Study groups in NCT06934889
Study groupRoleWhat they receive
Cohort A (Recurrent)Experimentalwill receive ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after standard surgery.
Receives: Drug: ERAS-801; Drug: ABBV-637
Cohort B (Recurrent)Experimentalwill receive ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after standard surgery
Receives: Drug: ERAS-801; Drug: ABBV-155
Cohort C (Newly Diagnosed)Experimentalwill receive ABBV-637 in combination with standard radiation and chemotherapy drug temozolomide.
Receives: Drug: ABBV-637; Drug: Temozolomide; Radiation: Radiotherapy
Cohort D (Newly Diagnosed)Experimentalwill receive ABBV-155 in combination with standard radiation and chemotherapy drug temozolomide
Receives: Drug: ABBV-155; Drug: Temozolomide; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

    All patients who receive a single dose of investigational drug will be included in the primary endpoint analysis. Will be measured descriptively using CTCAE v5.0

    Measured: 1 year

Secondary outcomes (2)

  1. Overall survival

    Overall survival will be defined from pre-surgical treatment start date to date of death due to any cause.

    Measured: 1 year

  2. Progression-free survival (PFS)

    Progression-free survival will be defined from pre-surgical treatment start date to date of progression or death due to any cause.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start7 Apr 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase Ib Trial of ABBV-637 or ABBV-155 in Combination with ERAS-801. The first eight patients were randomized 1:1 to: ABBV-637 or ABBV-155 (6 to cohorts A/B and 2 to cohorts C/D) using the Randomization Module in the Clinical Research Database (CRDB). Due to drug viability and impending expiration dates, the trial will no longer use randomization going forward beginning with patient 9. Participants will be assigned.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934889
Sponsor's protocol ID
24-409
Status last verified
Sep 2026
First submitted
11 Apr 2025
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ERAS-801, ABBV-637 and ABBV-155 in people with Glioblastoma and Gliosarcoma, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas Kaley, MD (212-639-5122, kaleyt@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06934889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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