NCT06620302 · Children's Oncology Group
Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma
What this study 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).
View original scientific description
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.
Interventions
BIOLOGICAL
Bcl-XL Proteolysis Targeting Chimera DT2216
Given IV
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
DRUG
Irinotecan
Given IV
Primary outcome measures
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose of study drug
AEs will be assessed and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. A descriptive summary of all toxicities will be reported.
Dose-limiting toxicity (DLT)
Time frame: Up to 21 days
AEs will be assessed and graded using NCI CTCAE v5.0. A descriptive summary of all toxicities will be reported.
Maximum tolerated dose (MTD)/ recommended phase 2 dose
Time frame: Up to 21 days
MTD will be defined as the maximum dose at which fewer than one-third of patients experience DLT during cycle 1 of therapy.
Area under the dose concentration curve of DT2216
Time frame: Up to 7 hours
Median (minimum \[min\], maximum \[max\]) area under the dose concentration curve of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Clearance of DT2216
Time frame: Up to 7 hours
Median (min, max) clearance of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Half-life of DT2216
Time frame: Up to 7 hours
Median (min, max) Half-life of DT2216 during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Area under the dose concentration curve of irinotecan
Time frame: Up to 7 hours
Median (min, max) area under the dose concentration curve of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Clearance of irinotecan
Time frame: Up to 7 hours
Median (min, max) clearance of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Half-life of irinotecan
Time frame: Up to 7 hours
Median (min, max) Half-life of irinotecan during cycle 1 assessed pre-dose, 5, 30, 60, 180, and 420 minutes post-dose.
Overall response rate (ORR)
Time frame: At start of treatment until disease progression or recurrence up to 60 months
ORR will be recorded from the start of the treatment until disease progression or recurrence. ORR of partial response, complete response or stable disease will be assessed according to Response Evaluation Criteria in Solid Tumors Criteria and will be reported descriptively.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PHASE 1: Patients between ≥ 1 year and ≤ 21 years of age at the time of study enrollment
- PHASE 2: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment
- PHASE 1: Patients with recurrent/refractory solid tumors excluding primary central nervous system tumors
- PHASE 2: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- PHASE 1: Patients must have either measurable or evaluable disease
- PHASE 2: Patients must have measurable disease
- PHASE 1: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- PHASE 2: Patients must have FLC which is recurrent/refractory to at least one line of prior systemic therapy
- Patients with FLC that is unresectable at initial diagnosis but is not recurrent/refractory to at least one
Where
- Birmingham, Alabama
- Los Angeles, California
- Orange, California
- San Francisco, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Atlanta, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations