Glioblastoma Multiforme
Conditions
Keywords
GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1
Brief summary
* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801. * To evaluate the antitumor activity of ERAS-801. * To evaluate the PK profile of ERAS-801.
Detailed description
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).
Interventions
DRUGERAS-801
Administered orally
Sponsors
Erasca, Inc.
Katmai Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Willing and able to give written informed consent * Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria * Adequate organ function * Willing to comply with all protocol-required visits, assessments, and procedures * Able to swallow oral medication
Exclusion criteria
* Prior treatment with an EGFR inhibitor for Glioblastoma * Currently enrolled in another therapeutic study * History of clinically significant cardiovascular disease * Gastrointestinal conditions that may affect administration/absorption of oral medications * Have an active infection (bacterial, fungal, or viral) requiring systemic therapy * Pregnant or breastfeeding women * Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study * Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT) | Study Day 1 up to Day 29 | Based on adverse events observed during dose escalation |
| Maximum Tolerated Dose (MTD) | Study Day 1 up to Day 29 | Based on adverse events observed during dose escalation |
| Recommended Dose (RD) | Study Day 1 up to Day 29 | Based on adverse events observed during dose escalation |
| Adverse Events | Assessed up to 24 months from time of first dose | Incidence and severity of treatment-emergent AEs and serious AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Assessed up to 24 months from time of first dose | Based on assessment of radiographic imaging per modified RANO response assessment |
| Plasma concentration (Cmax) | Study Day 1 up to Day 29 | Maximum plasma or serum concentration of ERAS-801 |
| Time to Response (TTR) | Assessed up to 24 months from time of first dose | Based on assessment of radiographic imaging per modified RANO response assessment |
| Duration of Response (DOR) | Assessed up to 24 months from time of first dose | Based on assessment of radiographic imaging per modified RANO response assessment |
| Time to achieve Cmax (Tmax) | Study Day 1 up to Day 29 | Time to achieve maximum plasma or serum concentration of ERAS-801 |
| Area under the curve | Study Day 1 up to Day 29 | Area under the plasma concentration-time curve of ERAS-801 |
| Half-life | Study Day 1 up to Day 29 | Half-life of ERAS-801 |
Countries
United States
Outcome results
None listed