OncoMatch/Clinical Trials/NCT05004116
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Is NCT05004116 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Repotrectinib and Irinotecan and temozolomide for advanced cancer.
Treatment: Repotrectinib · Irinotecan and temozolomide — This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced/metastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Allowed: ALK fusion
Allowed: NTRK1 fusion
Allowed: NTRK2 fusion
Allowed: NTRK3 fusion
Allowed: ROS1 fusion
Disease stage
Metastatic disease required
Metastatic Solid Tumor
Prior therapy
Must have received: standard therapy
Patients must have relapsed or refractory disease despite standard therapy
Cannot have received: irinotecan/temozolomide (irinotecan, temozolomide)
Exception: disease progression while on treatment
Disease progression while on treatment with irinotecan/temozolomide
Lab requirements
Blood counts
No bone marrow involvement: ANC ≥1000/mm^3, Platelet Count ≥100,000/mm^3 (transfusions allowed), Hemoglobin ≥ 8.0 g/dL (transfusions allowed); Known bone marrow involvement (phase 2): ANC ≥750/mm^3, Platelet Count ≥50,000/mm^3 (transfusions allowed), Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
Kidney function
Serum Creatinine or Creatinine Clearance within normal limits for age/gender or creatinine clearance or nuclear GFR ≥ 60 mL/min/1.73m^2; Adequate Renal Function using the Schwartz formula
Liver function
Total Serum Bilirubin <2.5 x ULN for age/gender; AST/ALT <2.5 x ULN for age/gender; <5 x ULN for age/gender if liver metastasis is present
Cardiac function
Echocardiogram with left ventricular shortening fraction >25% and QTc Friderica (QTcF) ≤ 470ms on screening electrocardiogram
See detailed organ function requirements in inclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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