Actively Recruiting
A Phase 1/2 Trial of CBL0137 in Patients With 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
N/A
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
Researchers are studying CBL0137, an experimental drug given intravenously, to find the best dose, side effects, and possible benefits for children and young adults aged 1 year to 21 years with relapsed or refractory solid tumors, including central nervous system tumors, lymphoma, and specific brain tumors like diffuse intrinsic pontine glioma (DIPG) and other H3 K27-altered diffuse midline gliomas (DMG). This phase I/II trial aims to estimate the maximum tolerated dose and assess the drug's anti-tumor effects and safety in these patients. Participants receive CBL0137 by intravenous infusion over 30 minutes on days 1 and 8 of each 21-day cycle, for up to 17 cycles if their disease does not progress or they do not experience unacceptable side effects. Patients may continue treatment despite pseudoprogression if their doctor agrees. Alongside treatment, patients undergo echocardiograms and blood sample collections regularly, and may have bone marrow aspirates or biopsies if needed. During the study, researchers monitor treatment effects through scans, blood tests, heart function tests, and biological markers in tumor and blood samples. Follow-up visits occur at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months after treatment ends to check long-term outcomes. The study measures include determining the best dose, observing tumor responses, tracking side effects, and analyzing drug levels over time.
CONDITIONS
Brief 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 aged between 12 months and 21 years at study enrollment
- Histologic verification of malignancy at original diagnosis or relapse, except certain brain tumors diagnosed by imaging or tumor markers
- Relapsed or refractory solid tumors or lymphoma, including CNS tumors or known CNS metastases
- Progressive or recurrent DIPG and other H3 K27-altered diffuse midline gliomas previously treated with radiation
- Measurable or evaluable disease (measurable disease required for certain subgroups)
- Disease state without known curative therapy or proven life-prolonging treatment
- Performance status score (Karnofsky or Lansky) of 50% or higher
- Full recovery from acute toxic effects of prior anti-cancer therapy with required waiting periods
- Adequate blood counts and organ function as specified
- Consent to receive a central venous catheter for drug administration
You will not qualify if you...
- Pregnant or breastfeeding women; pregnancy tests required for post-menarchal girls
- Unstable corticosteroid use within 7 days prior to enrollment
- Current use of investigational drugs or other anti-cancer agents (with exceptions for leukemia patients on hydroxyurea)
- Use of drugs to prevent graft-versus-host disease or strong enzyme inducers/inhibitors affecting drug metabolism
- Use of drugs with known risk of Torsades de Pointes arrhythmia
- Known peripheral vascular disease or history of pro-thrombotic disorders
- Uncontrolled infections
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 cycles of 21 days each
Participants receive CBL0137 intravenously over 30 minutes on days 1 and 8 of each 21-day cycle. Treatment repeats every 21 days for up to 17 cycles unless there is disease progression or unacceptable toxicity. Participants also undergo echocardiography and blood sample collection throughout treatment. Bone marrow aspirate and/or biopsy may be performed as clinically indicated.
2 visits per cycle (Days 1 and 8) plus additional visits for echocardiography and blood sample collection
Duration - Up to 60 months
After completing treatment, participants are followed up to monitor health and any long-term effects at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.
9 scheduled follow-up visits over 5 years
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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