Recruiting PHASE1 Glioblastoma

New treatment option for Glioblastoma

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

ClinicalTrials.gov ID: NCT06934889

What this study is testing

What is ERAS-801?

ERAS-801 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 1: an early, usually small safety study
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

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...
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...

You likely can't join if

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...
Patients with prior therapy with EGFR targeting agents are ineligible because treatment with EGFR kinase inhibitors or other EGFR-targeted agents has...
Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing...
Patients must not have evidence of significant hematologic, renal, or hepatic dysfunctioPatients must not have evidence of significant intracranial...
Patients with uncontrolled intercurrent illness including, but not limited to, hypertension, ongoing or active infection, symptomatic congestive...

See the full eligibility criteria

Who can 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 +/-...
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
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: a...
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...
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 people 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. a. If ECHO cannot be...
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...
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...
A negative serum pregnancy test for all female people (except postmenopausal) at the screening visit and a negative urine pregnancy test for all female people (except postmenopausal) at baseline before the first dose of...
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...
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...
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:
people with a history of hepatitis B that is considered cured may be enrolled at the discretion of the treating investigator.
people with a history of hepatitis C that is considered cured with definitive therapy may be enrolled at the discretion of the treating investigator.
people 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.

What rules you out

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...
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...
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...
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...
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...
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...
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...
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...
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.
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...

The study team makes the final eligibility decision.

Where it's taking place

Los Angeles, California, United States
Miami, Florida, United States
Indianapolis, Indiana, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Rockville Centre, New York, United States
Burlington, Vermont, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States; Miami, Florida, United States; Indianapolis, Indiana, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.