Actively Recruiting
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
Led by Children's Oncology Group · Updated on 2026-05-05
63
Participants Needed
35
Research Sites
256 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
I
Incuron LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.
CONDITIONS
Official Title
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 12 months to 21 years old at enrollment
- Histologic verification of malignancy at diagnosis or relapse, except for certain brain stem or pineal tumors with specific markers
- Part A: Patients with relapsed or refractory solid tumors or lymphoma, including CNS tumors or metastases
- Part B: Patients with progressive or recurrent DIPG and other H3 K27-altered DMG previously treated with radiation
- Part A: Measurable or evaluable disease required
- Part B: Measurable disease required
- No known curative therapy or proven survival-prolonging therapy available
- Performance status ECOG 0, 1, or 2 with Karnofsky or Lansky score ≥ 50%
- Fully recovered from toxic effects of prior anti-cancer therapy, meeting specified waiting periods
- No prior exposure to CBL0137
- Adequate blood counts and organ function within defined limits
- Shortening fraction ≥ 27% by echocardiogram or ejection fraction ≥ 50%
- Corrected QT interval < 480 msec
- Seizures well controlled without enzyme-inducing anti-convulsants
- Neurologic disorders from prior therapy ≤ grade 2 except any grade of decreased tendon reflex
- Consent to receive a central venous catheter prior to CBL0137 administration
You will not qualify if you...
- Pregnant or breast-feeding women
- Patients not on stable or decreasing corticosteroid dose for at least 7 days prior to enrollment
- Currently receiving another investigational drug or other anti-cancer agents (except specified exceptions)
- Receiving drugs to prevent graft-versus-host disease post bone marrow transplant
- Taking strong inducers or inhibitors of CYP3A4, CYP2B6, CYP1A2, or drugs with TdP risk
- Known peripheral vascular disease or history of pro-thrombotic disorder
- Uncontrolled infection
- Prior solid organ transplantation
- Inability to comply with safety monitoring requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
5
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
9
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
10
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
11
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
12
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
13
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
16
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
17
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
18
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
19
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
20
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
21
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
22
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
23
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
24
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
25
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
26
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
27
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
28
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
29
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
30
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
32
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
33
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
34
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
35
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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