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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06934889
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (Recurrent)
    will receive ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after standard surgery.
  • Experimental: Cohort B (Recurrent)
    will receive ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after standard surgery
  • Experimental: Cohort C (Newly Diagnosed)
    will receive ABBV-637 in combination with standard radiation and chemotherapy drug temozolomide.
  • Experimental: Cohort D (Newly Diagnosed)
    will receive ABBV-155 in combination with standard radiation and chemotherapy drug temozolomide

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: 1 year ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (Data Collection Only)Los AngelesCalifornia90095
Phioanh Nghiemphu, MD
310-206-6909
University of Miami (Data collection only)MiamiFlorida33136
Macarena De La Fuente, MD
Indiana University (Data Collection Only)IndianapolisIndiana46202
Kathryn Nevel, MD
317-948-5450
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Thomas Kaley, MD
212-639-5122
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Thomas Kaley, MD
212-639-5122
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Thomas Kaley, MD
212-639-5122
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Thomas Kaley, MD
212-639-5122
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Thomas Kaley, MD
212-639-5122
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Thomas Kaley, MD
212-639-5122
Ingo Mellinghoff, MD
646-888-2766
Thomas Kaley, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Rockville CentreNew York11553
Thomas Kaley, MD
212-639-5122
University of Vermont Medical CenterBurlingtonVermont05401
Alissa Thomas, MD
802-847-8400

Find similar trials in Los Angeles, CA

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By specialty
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By research site
University of California, Los Angeles (Data Collection Only)· Los Angeles, CAUniversity of Miami (Data collection only)· Miami, FLIndiana University (Data Collection Only)· Indianapolis, INMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJ

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