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 (Jun 2026). This Phase 2 trial studies multiple treatments for high grade glioma.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: NTRK1 fusion
Required: NTRK2 fusion
Required: NTRK3 fusion
Required: ROS1 fusion
Demographics
Prior therapy
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 →Frequently asked questions
Is NCT06528691 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require NTRK1?
Yes, NTRK1 fusion is a required biomarker for enrollment.
Does this trial require NTRK2?
Yes, NTRK2 fusion is a required biomarker for enrollment.
Does this trial require NTRK3?
Yes, NTRK3 fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 3 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages