A Phase 1 interventional study of ERAS-801 in Glioblastoma Multiforme, sponsored by Katmai Pharmaceuticals Inc.. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Katmai Pharmaceuticals Inc. · Phase 1, Interventional, and Treatment
This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).
1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 52 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →This is the only study on the registry with Katmai Pharmaceuticals Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
Drug: ERAS-801
ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR.
Drug: ERAS-801
Administered orally
Dose Limiting Toxicities (DLT)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Maximum Tolerated Dose (MTD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Recommended Dose (RD)
Based on adverse events observed during dose escalation
Time frame: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma or serum concentration of ERAS-801
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma or serum concentration of ERAS-801
Time frame: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-801
Time frame: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-801
Time frame: Study Day 1 up to Day 29
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per modified RANO response assessment
Time frame: Assessed up to 24 months from time of first dose
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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