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OncoMatch/Clinical Trials/NCT06528691

Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Is NCT06528691 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for high grade glioma.

Phase 2RecruitingSt. Jude Children's Research HospitalNCT06528691Data as of May 2026

Treatment: Entrectinib · Cyclophosphamide · Etoposide · Carboplatin · G-CSF · Pegfilgrastim — This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: NTRK1 fusion

Required: NTRK2 fusion

Required: NTRK3 fusion

Required: ROS1 fusion

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines
Min 0 prior lines

Cannot have received: cytotoxic chemotherapy

Exception: excluding Bridging Chemotherapy Cycle

Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation

Cannot have received: targeted therapy

Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation

Cannot have received: immunotherapy

Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation

Cannot have received: cellular therapy

Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation

Cannot have received: radiation therapy

Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation

Lab requirements

Blood counts

Hemoglobin ≥ 8 g/dL (without transfusion or erythropoietin use within 7 days prior to enrollment); Platelet count ≥ 75,000/µL (without transfusion within 7-day period prior to enrollment); Absolute neutrophil count >1,000/µL

Kidney function

Adequate renal function as defined by age-based serum creatinine: 0 to <1 year: 0.5 mg/dL; 1 to <2 years: 0.6 mg/dL; 2 to 3 years: 0.8 mg/dL

Liver function

AST and ALT ≤2.5x ULN; Bilirubin ≤ 1.5 x ULN

Cardiac function

ECG with QTc ≤ 450 msec and echocardiogram LVEF >50%

Hemoglobin ≥ 8 g/dL (without transfusion or erythropoietin use within 7 days prior to enrollment); Platelet count ≥ 75,000/µL (without transfusion within 7-day period prior to enrollment); Absolute neutrophil count >1,000/µL; AST and ALT ≤2.5x ULN; Bilirubin ≤ 1.5 x ULN; Adequate renal function as defined by age-based serum creatinine: 0 to <1 year: 0.5 mg/dL; 1 to <2 years: 0.6 mg/dL; 2 to 3 years: 0.8 mg/dL; ECG with QTc ≤ 450 msec and echocardiogram LVEF >50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • St. Jude Children's Research Hospital · Memphis, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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