Study on Adding DT2216 to Usual Chemotherapy for Relapsed or Hard-to-Treat Solid Tumors and Fibrolamellar Carcinoma
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT06620302
This clinical trial is testing a new drug, DT2216, combined with the usual chemotherapy drug irinotecan, to see if it is safe and effective for children, teens, and young adults with solid tumors or fibrolamellar carcinoma that have returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if a new drug, DT2216, when used with the chemotherapy drug irinotecan, is safe and can help treat children, adolescents, and young adults with solid tumors or fibrolamellar carcinoma that have come back or not responded to other treatments. DT2216 works by targeting a protein that helps cancer cells survive, while irinotecan blocks an enzyme needed for cancer cell growth. The study will test different doses to find the safest and most effective amount of DT2216 to use with irinotecan.
Description
The main goals of this study are to find the best dose of DT2216 when combined with irinotecan, understand the side effects, and see how well this combination works against tumors. Researchers will also study how the body processes DT2216 and its effects on cancer cells.
Participants will receive DT2216 through an IV on specific days of each treatment cycle, along with irinotecan. Each cycle lasts 21 days, and treatment can continue for up to 24 months if it is effective and well-tolerated. Blood samples will be collected throughout the study to monitor health and treatment effects.
After finishing the treatment, participants will have follow-up visits at regular intervals to check their health and the long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Phase 1: Ages 1 to 21 years old.
- Phase 2: Ages 1 to 39 years old.
- Phase 1: Have solid tumors that have returned or not responded to treatment, excluding brain tumors.
- Phase 2: Have fibrolamellar carcinoma confirmed by specific genetic testing.
- Must have measurable or evaluable disease.
- Must be in good overall health with a performance status score of 0, 1, or 2.
- Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Must have adequate blood counts and organ function.
- Must not have received prior Bcl-xL specific therapy.
- Must not have active infections or uncontrolled medical conditions.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Must not be taking corticosteroids unless on a stable dose for at least 7 days.
- Cannot be taking other investigational drugs or anti-cancer agents.
- Cannot have uncontrolled infections or grade 2 or higher diarrhea.
- Cannot have had a solid organ transplant.
- Cannot have active central nervous system metastasis.
- Cannot have a corrected QT interval over 480 ms on an EKG.
- Must not have had recent surgeries within specified timeframes before enrollment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Children's National Medical Center | 20010 | Washington D.C. | District of Columbia |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | 30329 | Atlanta | Georgia |
| Lurie Children's Hospital-Chicago | 60611 | Chicago | Illinois |
| Riley Hospital for Children | 46202 | Indianapolis | Indiana |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| C S Mott Children's Hospital | 48109 | Ann Arbor | Michigan |
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