60 Participants Needed

ABBV-637 + ERAS-801 for Glioblastoma

Recruiting at 6 trial locations
TK
Overseen ByThomas Kaley, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment 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 specific mutations in the tumor, leading to improved survival rates. Additionally, oncolytic virus therapies have shown potential in creating strong immune responses against glioblastoma, suggesting that innovative approaches can be effective.12345

Who Is on the Research Team?

TK

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
See 14 more

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
See 13 more

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?
4Treatment groups
Experimental Treatment
Group I: Cohort D (Newly Diagnosed)Experimental Treatment3 Interventions
will receive ABBV-155 in combination with standard radiation and chemotherapy drug temozolomide
Group II: Cohort C (Newly Diagnosed)Experimental Treatment3 Interventions
will receive ABBV-637 in combination with standard radiation and chemotherapy drug temozolomide.
Group III: Cohort B (Recurrent)Experimental Treatment2 Interventions
will receive ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after standard surgery
Group IV: Cohort A (Recurrent)Experimental Treatment2 Interventions
will receive ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after standard surgery.

Find a Clinic Near You

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

Citations

A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. [2023]
CD137 and PD-L1 targeting with immunovirotherapy induces a potent and durable antitumor immune response in glioblastoma models. [2022]
Personalizing Oncolytic Virotherapy for Glioblastoma: In Search of Biomarkers for Response. [2021]
Genetic modification of neurons to express bevacizumab for local anti-angiogenesis treatment of glioblastoma. [2018]
Rindopepimut: an evidence-based review of its therapeutic potential in the treatment of EGFRvIII-positive glioblastoma. [2021]
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