Actively Recruiting
Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma
Led by Children's Oncology Group · Updated on 2026-05-05
81
Participants Needed
21
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.
CONDITIONS
Official Title
Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase 1: Patients aged 1 to 21 years at enrollment
- Phase 2: Patients aged 1 to 39 years at enrollment
- Phase 1: Patients with recurrent or refractory solid tumors excluding primary central nervous system tumors
- Phase 2: Patients with fibrolamellar carcinoma confirmed by DNAJB1:PRKACA fusion test
- Phase 1: Patients must have measurable or evaluable disease
- Phase 2: Patients must have measurable disease
- Phase 1: Disease with no known curative therapy or proven survival-prolonging therapy
- Phase 2: Fibrolamellar carcinoma recurrent or refractory to at least one prior systemic therapy
- Patients must have ECOG performance status of 0, 1, or 2 (Karnofsky for >16 years, Lansky for ≤16 years)
- Patients must have recovered from prior anti-cancer therapy within specified time frames
- No prior Bcl-xL targeted therapy; prior irinotecan or non-Bcl-xL selective BH3 mimetics allowed
- Patients without known bone marrow involvement: ANC ≥ 1000/µL and platelets ≥ 100,000/µL without recent transfusions
- Patients with bone marrow disease may enroll if blood counts meet criteria
- Age and gender-specific creatinine limits or adequate kidney function measures
- Liver function tests within defined limits
- Patients with controlled seizure disorders are eligible
- Nervous system disorders from prior therapy must be grade ≤ 2 except for any grade of decreased tendon reflex
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients not using effective contraception if of reproductive potential
- Patients on unstable or recently changed corticosteroid doses
- Patients receiving other investigational or anti-cancer drugs
- Patients on cyclosporine, tacrolimus, or similar post bone marrow transplant agents
- Patients who took strong CYP3A4 inducers or inhibitors within 14 days before enrollment
- Patients with lymphoma
- Patients with uncontrolled infections
- Patients with grade ≥ 2 diarrhea at baseline
- Patients with prior solid organ transplant
- Patients unable to comply with study safety monitoring
- Patients with active central nervous system metastases
- Patients with corrected QT interval > 480 ms at baseline
- Recent surgeries or biopsies within defined time frames before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
4
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
16
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
17
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
19
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
20
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
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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