A new clinical trial for fibrolamellar patients is now enrolling patients! This phase 1/2 study, Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma, will test the safety, side effects and best dose of DT2216 in combination with the chemotherapy agent, irinotecan. DT2216 is an experimental drug developed by Dialectic Therapeutics, Inc. that is designed to overcome a major mechanism through which cancer cells may resist chemotherapy.
The clinical trial is led by pediatric oncologists Dr. Michael Ortiz (Memorial Sloan Kettering Cancer Center) and Dr. Allison O’Neill (Dana-Farber Cancer Institute). Patients will be able to enroll at multiple hospitals affiliated with the Children’s Oncology Group’s Pediatric Early Phase-Clinical Trial Network (PEP-CTN).
The initial Phase 1 portion of this study will enroll in patients between ages 1 and 21 years with solid tumors that have recurred or failed to respond to other treatments. Its main goal will be to determine a recommended Phase 2 dose of DT2216, administered in combination with a standard dose of irinotecan. The Phase 2 portion of the study will be carried out exclusively in FLC patients up to 39 years old. DT2216 will be administered at the recommended dose established in Phase 1, together with irinotecan at its standard dose. The main goal of the Phase 2 portion will be to define anti-tumor activity of the DT2216/irinotecan combination in FLC patients.
FCF is supporting this effort by funding the manufacturing of the DT2216 necessary to conduct the trial. According to John D. Harkey, Jr., Dialectic Therapeutic’s Executive Chairman & Co-founder, “We are excited about our partnership with the Fibrolamellar Cancer Foundation which will provide Dialectic the financial backing necessary to allow the clinical testing of this drug in fibrolamellar patients.”
FLC patients who are interested in participating in the study should consult their medical oncologist as soon as possible, since enrollment will be limited. More information about the trial is available at clinicaltrials.gov/study/NCT06620302.