A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Relapsed Ewing Sarcoma

Intervention / Treatment
-----------------
* Drug: INCB059872


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCB059872<br>INCB059872 | Drug: INCB059872<br>* 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.<br>|

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed Ewing sarcoma, bromodomain-containing protein (BRD) inhibitor, lysine demethylase 1 (LSD1) inhibitor