Health TrialsbyHealthPanel

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

ConditionsGlioblastomaGliosarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • ERAS-801

    Drug

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

  • ABBV-637

    Drug

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

  • ABBV-155

    Drug

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

  • Temozolomide

    Drug

    Temozolomide will be continued for 6 cycles after radiation.

  • Radiotherapy

    Radiation

    will be given as per standard of care radiation for GBM

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Cohort A (Recurrent)Experimental treatment 2 interventions
Group B: Cohort B (Recurrent)Experimental treatment 2 interventions
Group C: Cohort C (Newly Diagnosed)Experimental treatment 3 interventions
Group D: Cohort D (Newly Diagnosed)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Time frame
1 year

Secondary outcomes

1

Overall survival

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

Time frame
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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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