ABBV-637 + ERAS-801 for Glioblastoma

Recruiting at 6 trial locations

Overseen By Thomas Kaley, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: EGFR-targeting agents, EIAEDs

Disqualifiers: Uncontrolled illness, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of two experimental drugs, ABBV-637 and ABBV-155, either alone or combined with ERAS-801, for treating glioblastoma, an aggressive brain cancer. Researchers aim to determine if these treatments cause only mild or few side effects, particularly for those whose cancer has returned after previous treatments. Participants may receive different combinations of these drugs before and after surgery or alongside standard treatments like radiation and chemotherapy. The trial seeks individuals with glioblastoma that has returned or is newly diagnosed and who are planning to undergo surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot be on enzyme-inducing anti-epileptic drugs or certain other medications that interact with the study drugs. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ABBV-155 is promising in terms of safety. Early data from studies indicate that this drug is safe for humans, as no maximum tolerated dose (the highest dose without severe side effects) has been reached yet. This suggests the treatment is generally well-tolerated. Additionally, ABBV-155 has effectively shrunk tumors and improved survival rates when combined with radiation in lab tests before human trials.

For ABBV-637, specific safety data from past studies is not available. However, as this is a Phase 1 study, the main focus is on safety and determining the right dose. Researchers are closely monitoring for any side effects to ensure the treatment is safe for people.

Both treatments are being tested with other therapies for glioblastoma, a type of brain cancer. This study is an important step in confirming the safety and proper dosage of these drugs for future use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-637 and ABBV-155 for glioblastoma because they offer a fresh approach to tackling this aggressive brain cancer. Unlike standard treatments that primarily involve surgery, radiation, and temozolomide chemotherapy, ABBV-637 and ABBV-155 introduce new mechanisms. ABBV-637 is being tested in combination with ERAS-801, potentially enhancing the efficacy of post-surgery treatments. ABBV-155, meanwhile, brings a novel twist by being trialed both before and after surgery, possibly improving tumor reduction and patient outcomes. These innovative approaches could complement existing therapies, offering hope for better management of glioblastoma.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

Research has shown that ABBV-637, one of the treatments in this trial, appears promising when combined with ERAS-801, as it targets specific proteins in cancer cells. Participants in Cohort A will receive ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after surgery. ABBV-155, another treatment option in this trial, has also demonstrated potential. Studies suggest it can shrink tumors and extend patient survival, especially when combined with radiation. Participants in Cohort B will receive ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after surgery. ERAS-801 blocks a protein that aids cancer cell growth and spread, potentially enhancing the effects of both ABBV-637 and ABBV-155. These findings suggest these drugs could effectively treat glioblastoma. ^{1 6 7 8 9}

Who Is on the Research Team?

Thomas Kaley, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent glioblastoma, a type of brain cancer. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have tried standard treatments first.

Inclusion Criteria

Patients must have Echocardiogram with ejection fraction ≥ 50%

Patients must have measurable disease as per RANO criteria pre-operatively

Patients must be able to tolerate MRIs

Exclusion Criteria

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 must not have evidence of significant intracranial hemorrhage

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABBV-637 or ABBV-155 in combination with ERAS-801, with additional standard treatments for newly diagnosed patients

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-155
• ABBV-637
• ERAS-801

Trial Overview The study is testing the safety and side effects of two drugs, ABBV-637 and ABBV-155, alone or combined with ERAS-801 in treating recurrent glioblastoma. The trial will likely include radiotherapy and Temozolomide as part of the treatment regimen.

How Is the Trial Designed?

Group I: Cohort D (Newly Diagnosed) Experimental Treatment 3 Interventions

will receive ABBV-155 in combination with standard radiation and chemotherapy drug temozolomide

Group II: Cohort C (Newly Diagnosed) Experimental Treatment 3 Interventions

will receive ABBV-637 in combination with standard radiation and chemotherapy drug temozolomide.

Group III: Cohort B (Recurrent) Experimental Treatment 2 Interventions

will receive ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after standard surgery

Group IV: Cohort A (Recurrent) Experimental Treatment 2 Interventions

will receive ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after standard surgery.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

AAV-mediated gene therapy successfully delivered the anti-VEGF monoclonal antibody bevacizumab directly to glioblastoma tumors in mice, leading to reduced tumor volume and increased survival rates.

This method effectively circumvents the blood-brain barrier, demonstrating potential for localized and persistent treatment of glioblastoma multiforme, which typically has a median survival of only 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic modification of neurons to express bevacizumab for local anti-angiogenesis treatment of glioblastoma. Hicks, MJ., Funato, K., Wang, L., et al.[2018]

Rindopepimut, a peptide vaccine targeting the EGFRvIII mutation found in 20-30% of glioblastoma multiforme (GBM) cases, has shown significantly improved progression-free and overall survival rates in patients, making it a promising treatment option.

The vaccine has minimal side effects, primarily hypersensitivity reactions, indicating a favorable safety profile compared to current non-specific therapies for GBM, which often result in toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rindopepimut: an evidence-based review of its therapeutic potential in the treatment of EGFRvIII-positive glioblastoma. Babu, R., Adamson, DC.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06934889

NCT06934889 | Study of ABBV-637 or ABBV-155 With ... Study Overview​​ 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 ...

2. mskcc.org mskcc.org/cancer-care/clinical-trials/24-409

A Phase 1b Study of ABBV-637 or ABBV-155 With ERAS- ... This study is assessing ABBV-637 and ABBV-155 with ERAS-801 or standard treatment in people with glioblastoma.

3. withpower.com withpower.com/trial/phase-1-glioblastoma-3-2025-ee808

ABBV-637 + ERAS-801 for Glioblastoma While there is no direct data on ABBV-637 + ERAS-801, research on similar treatments like rindopepimut shows promising results in glioblastoma by targeting ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-03083

Study of ABBV-637 or ABBV-155 With ERAS-801 for ... This phase Ib trial studies the side effects of ABBV-637 or ABBV-155 in combination with ERAS-801 and to see how well they work in treating patients with ...

5. synapse.patsnap.com synapse.patsnap.com/drug/a30e624c1a214fae8c923eec1b4c7240

ABBV-637 - Drug Targets, Indications, Patents A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With ...

6. braintumor.org braintumor.org/news/turning-resistance-into-vulnerability-nbts-funded-discovery-drives-new-glioblastoma-clinical-trial%EF%BF%BC/

NBTS-Funded Discovery Drives New Glioblastoma Clinical ... In preclinical models, ABBV-155 caused dramatic tumor cell death, shrank tumors, and improved survival — especially when paired with radiation ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11582606/

Integrated molecular and functional characterization of the ... Notably, early clinical data indicate ABBV-155 is safe in humans with a maximum tolerated dose (MTD) not reached and, unlike previous ...

8. ddw-online.com ddw-online.com/ml-study-identifies-new-glioblastoma-treatment-strategy-32668-202411/

ML study identifies new glioblastoma treatment strategy “We found that combining standard therapies with ABBV-155 successfully induced tumour shrinkage, which is something we rarely observe in ...

9. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1595642/full

Comparative safety analysis of bevacizumab and alkylating ... Our results indicate that glioblastoma patients treated with bevacizumab may have a higher risk of adverse events in specific System Organ ...