A Study of ERAS-601 in People With Chordoma (NCT06957327) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of ERAS-601 in People With Chordoma
United States12 participantsStarted 2025-04-25
Plain-language summary
The researchers are doing this study is to find out whether ERAS-601 is a safe and effective treatment that causes few or mild side effects in people with advanced and progressing chordoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years.
* Have histologically confirmed chordoma that is not dedifferentiated or poorly differentiated subtype.
* Have progressive disease per RECIST 1.1 defined by +20% change between any two scans in the 9 months prior to enrollment.
* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
* Recovered from acute, clinically significant toxicities associated with current/recent treatments to acceptable baseline status
* Screening laboratory values must meet the following criteria and should be obtained within 30 days prior to study treatment:
* Absolute neutrophil count (ANC) ≥ 1.5 x 103/m
* Platelet count ≥ 75 × 103/mL without symptomatic bleeding
* Hemoglobin \> 9 g/dL
* Serum electrolytes (sodium, potassium, magnesium, phosphorus, calcium) Grade ≤1 or within the institutional ranges of normal. If clinically appropriate, electrolytes may be corrected, and values reassessed prior to enrollment.
* AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases
* Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL)
* Serum creatinine clearance \<1.5 times ULN or ≥ 50 mL/min as determined by Cockcroft-Gault (Appendix 7) (creatinine clearance need not be calculated if serum creatinine is within normal limits).
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days p…