DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma
The trial is sponsored by the Children's Oncology Group and aims to evaluate the safety and efficacy of DT2216 in combination with irinotecan for treating relapsed or refractory solid tumors, particularly fibrolamellar carcinoma (FLC) in pediatric and young adult populations. Given the limited treatment options for these patient groups, successful outcomes could position DT2216 as a novel therapeutic option, potentially capturing a niche market in pediatric oncology. The combination therapy may also enhance the competitive landscape against existing treatments, particularly for FLC, which has a unique molecular profile. The trial's focus on a specific genetic marker (DNAJB1:PRKACA fusion) in FLC could provide a targeted approach, appealing to precision medicine strategies in oncology. Stakeholders should monitor the trial's progress closely for potential partnership or acquisition opportunities, especially if early results indicate significant efficacy.
Indication: Childhood Fibrolamellar Carcinoma
Modality: protein therapy
Target: Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.
Sponsor: Children's Oncology Group
Source URL: ClinicalTrials.gov
Source updated: May 05, 2026
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.
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Condition raw: Childhood Fibrolamellar Carcinoma, Recurrent Childhood Fibrolamellar Carcinoma, Recurrent Childhood Malignant Solid Neoplasm, Recurrent Fibrolamellar Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Childhood Fibrolamellar Carcinoma, Refractory Childhood Malignant Solid Neoplasm, Refractory Fibrolamellar Carcinoma, Refractory Malignant Solid Neoplasm
Condition normalized: Childhood Fibrolamellar Carcinoma, Recurrent Childhood Fibrolamellar Carcinoma, Recurrent Childhood Malignant Solid Neoplasm, Recurrent Fibrolamellar Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Childhood Fibrolamellar Carcinoma, Refractory Childhood Malignant Solid Neoplasm, Refractory Fibrolamellar Carcinoma, Refractory Malignant Solid Neoplasm
Modality raw: protein therapy
Modality normalized: protein therapy
Target raw: Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.
Target normalized: Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.