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A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor

A Phase II Study of Oral CHK1 Inhibitor LY2880070 in Combination With Low-Dose Gemcitabine in Patients With Relapsed or Refractory Ewing Sarcoma, Ewing-like Sarcoma, and Desmoplastic Small Round Cell Tumor

NCT05275426•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether LY2880070 combined with the chemotherapy drug gemcitabine is an effective treatment for Ewing sarcoma or Ewing-like sarcoma.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Consent/Assent: all patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
•Weight/Age: patients must be ≥40 kg at the time of study enrollment, but may be of any age
•Diagnosis: Patients must have histologically documented locally advanced or metastatic disease confirmed at MSK as follows:
•* Main cohort: Ewing sarcoma as molecularly defined by an EWSR1 fusion with an ETS-transcription factor family member including FLI1, ERG, ETV1, ETV4, and FEV
•* Pilot cohort: Ewing-like sarcomas including CIC-rearranged sarcoma, BCOR-rearranged sarcoma, and sarcomas with a rearrangement between EWSR1 and a non-ETS family gene or desmoplastic small round cell tumor as molecularly defined by an EWSR1-WT1 fusion
•Note: Any patient being enrolled into the pilot cohort that does not have a CIC, BCOR- rearranged sarcoma, or desmoplastic small round cell tumor will be reviewed with study pathologist, Dr. Cristina Antonescu, to ensure the categorization as Ewing-like sarcoma is appropriate
•Patients must be able to swallow capsules
•Therapeutic options: patient's current disease state must be one which has failed standard cytotoxic chemotherapy including cyclophosphamide/doxorubicin/vincristine and ifosfamide/etoposide
•Disease Status: patients must have measurable disease based on RECIST 1.1
•Performance level: Karnofsky ≥70% for patients \>16 years of age and Lansky ≥70 for patients ≤16 years of age
+24 more criteria

Exclusion Criteria

•Patients for whom the investigator deems that gemcitabine is not appropriate
•Patients who have an uncontrolled infection
•Central Nervous System (CNS) Metastases
•* Patients who have symptomatic central nervous system (CNS) metastases. Note: patients with treated and asymptomatic CNS metastases are eligible.
•* Patients with CNS metastases requiring corticosteroids for management
•* If the treatment of CNS disease requires anticonvulsants, the dose must have been stable for ≥ 4 weeks.
•Patients who are pregnant or breast feeding
•Patients who have a history of Torsades de Pointes, carry a diagnosis of congestive heart failure, or have a family history of prolonged QT syndrome
•Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
•Patients with known hypersensitivity to gemcitabine

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Key Dates

Start Date

March 2, 2022

Primary Completion Date

August 11, 2025

Completion Date

August 11, 2025

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Ewing SarcomaEwing-Like Sarcoma

Interventions

LY2880070

DRUG

Gemcitabine

DRUG

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

NCT03715933

Ewing Sarcoma

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RECRUITINGPHASE1/PHASE2

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

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NeuroblastomaEwing Sarcoma+3 more

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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: August 15, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor

Inclusion Criteria

Exclusion Criteria

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

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