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RECRUITINGPHASE1/PHASE2

A Study of ERAS-601 in People With Chordoma

A Phase 1b/2 Study of ERAS-601 SHP2 Inhibitor as a Monotherapy in Patients With Advanced and Progressing Chordoma

NCT06957327•Memorial Sloan Kettering Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

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.
+5 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

April 25, 2025

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2027

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Chordoma

Interventions

ERAS-601

DRUG

Contacts

Mrinal Gounder, MD

CONTACT

646-888-4167 zzPDL_MED_Sarcoma_Clinical_Trials <zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org>

Robert Maki, MD, PhD

CONTACT

646-888-5059 zzPDL_MED_Sarcoma_Clinical_Trials <zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org>

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ERAS-601 in People With Chordoma

Inclusion Criteria

Exclusion Criteria

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