ChordomaPhase 1/2NCT06957327
A Study of ERAS-601 in People With Chordoma
A Phase 1/2 study testing ERAS-601 in people with Chordoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma
- What is being tested?
- ERAS-601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Apr 2025to Apr 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- Non-English speaking patients will not be required to complete patient reported outcomes.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: A Phase 1b/2 Study of ERAS-601 SHP2 Inhibitor as a Monotherapy in Patients With Advanced and Progressing Chordoma
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.
- Conditions
- Chordoma
- Being tested
- ERAS-601
- Keywords
- Advanced and Progressing Chordoma, ERAS-601 SHP2 Inhibitor, 25-071
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-601Drug
ERAS-601 40mg BID, 3-weeks on 1-week off (3/1), as monotherapy
| Study group | Role | What they receive |
|---|---|---|
| ERAS-601 | Experimental | All patients on the single-arm Phase 1b study will take ERAS-601 40mg BID, 3-weeks on 1-week off (3/1), as monotherapy. Each treatment cycle consists of a 4-week (28-day) treatment period. Receives: Drug: ERAS-601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (Phase Ib)
proportion of patients with CR or PR at any time or SD ≥ 6 months per RECIST 1.1)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start25 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChordomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Phase 1b portion is a single-arm, single-center pilot study to evaluate the efficacy and safety of SHP2 inhibitor ERAS-601 for the treatment of advanced and progressing chordoma.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinal Gounder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957327
- Sponsor's protocol ID
- 25-071
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.