A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma

The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.

Study Overview

• Status: Terminated
• Conditions: Relapsed Ewing Sarcoma
• Intervention / Treatment: Drug: INCB059872

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola-Malpighi
  • Rome, Italy, 00146
    • Ospedale Pediatrico Bambino Gesù IRCCS
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Jonsson Comprehensive Cancer
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville - PPDS
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
• Must not be a candidate for potentially curative therapy or standard-of-care approved therapy.
• Measurable disease by computed tomography or magnetic resonance imaging based on RECIST 1.1 as determined by site radiology.
• Eastern Cooperative Oncology Group performance status 0 to 2.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
• Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
• Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
• Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
• Laboratory values outside the protocol-defined range at screening.
• History or evidence of bleeding disorder or active clinically significant bleeding requiring medical intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCB059872	Drug: INCB059872; Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria. Part 2: Expansion with the recommended dose from Part 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related.	Screening through 30 days after last dose of study treatment, up to approximately 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Defined as the percentage of participants who have a complete response or partial response as determined by investigator assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to approximately 6 months.
Cmax of INCB059872	Defined as maximum observed plasma concentration.	Up to approximately 2 weeks.
tmax of INCB059872	Defined as time to maximum concentration.	Up to approximately 2 weeks.
t½ of INCB059872	Defined as apparent terminal-phase disposition half-life.	Up to approximately 2 weeks.
Cl/F of INCB059872	Defined as apparent oral dose clearance.	Up to approximately 2 weeks.

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Fred Zheng, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Relapsed Ewing sarcoma; bromodomain-containing protein (BRD) inhibitor; lysine demethylase 1 (LSD1) inhibitor
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma, Ewing; INCB059872
• Other Study ID Numbers: INCB 59872-103; 2018-000062-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No