Testing ERAS-601 for treating chordoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of ERAS-601, a SHP2 inhibitor, in patients with advanced and progressing chordoma. Participants must be at least 18 years old and have confirmed chordoma that is not dedifferentiated or poorly differentiated. The study aims to determine if ERAS-601 can provide a treatment option with minimal side effects for this challenging condition. Patients will be monitored for disease progression and treatment response according to established criteria.

Why it matters

Who can join: the full rules

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 prior to receiving the first dose of study medication.

* Female patients of childbearing potential must be willing to use an adequate method of contraception, as outlined in the protocol, for the course of the study through 120 days after last dose of study medication.
* Male patients of childbearing potential must agree to use an adequate method of contraception, as outlined in the protocol, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
* Willing to comply with all protocol required- visits, assessments, and procedures.
* Willing to participate in patient interviews for quality-of-life assessment and complete patient reported outcomes (PRO) questionnaires

Exclusion Criteria:

* Previous treatment with a SHP2 inhibitor.
* Documented PTPN11 mutations.
* Is currently receiving another treatment within 4 weeks of the first dose of ERAS-601 that may impact the outcome of this trial.
* Patients with prior antineoplastic therapy within \<21 days or 5 half-lives, whichever is shorter.
* Received radiation within 14 days of Cycle 1, Day 1.
* Received strong inhibitors or inducers of CYP3A4, including grapefruit, grapefruit juice, and herbal supplements from 7 days prior to the administration of study drug.
* History of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic soft tissue calcification.
* Gastrointestinal dysfunction that may affect drug absorption.
* Have an untreated, uncontrolled, active infection (bacterial, fungal, or viral) requiring treatment that will impact this protocol.
* History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO.
* Sight-limiting degenerative corneal opacity.
* Have any underlying medical condition (e.g. cardiac, pulmonary, hepatic, etc.), psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise patient safety and/or efficacy evaluation as per protocol.
* Incomplete recovery or ongoing complications from prior surgery that in the opinion of the principal investigator will compromise safety of patient and/or efficacy evaluation of protocol.
* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study therapy.
* Have a second malignancy that is active and in the opinion of the principal investigator will compromise safety of patient and/or efficacy evaluation of protocol.

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Mrinal Gounder, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Mrinal Gounder, MD
• Email: zzPDL_MED_Sarcoma_Clinical_Trials <zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org>
• Phone: 646-888-4167

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.