A Study of ERAS-601 in People With Chordoma

NCT06957327 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-071
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Chordoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate (Phase Ib)

  proportion of patients with CR or PR at any time or SD ≥ 6 months per RECIST 1.1)

  1 year

Study Arms (1)

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.

Drug: ERAS-601

Interventions

ERAS-601 DRUG

ERAS-601 40mg BID, 3-weeks on 1-week off (3/1), as monotherapy

ERAS-601

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

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

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Mrinal Gounder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)