RECRUITING

A Study of ERAS-601 in People With Chordoma

Conditions

Chordoma Advanced and Progressing Chordoma ERAS-601 SHP2 Inhibitor 25-071

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-25

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06957327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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.

Inclusion Criteria

Exclusion 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 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

* 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.

Contacts and Locations

Study Contact

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>

Principal Investigator

Mrinal Gounder, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

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

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Mrinal Gounder, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-25

Study Completion Date2027-04

Study Record Updates

Study Start Date2025-04-25

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Advanced and Progressing Chordoma
ERAS-601 SHP2 Inhibitor
25-071

Additional Relevant MeSH Terms

Chordoma