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Repotrectinib in Combination With Chemotherapy in Pediatric and Young Adult Subjects With Advanced or Metastatic Solid Tumors and Primary CNS Tumors
NCT05004116Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2021
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- repotrectinib
- Conditions
- cancermetastatic solid tumorprimary central nervous system tumorneuroblastomadesmoplastic small round cell tumor (DSRCT)
01
Overview
Phase 2, open-label trial of repotrectinib in cancer, metastatic solid tumor, primary central nervous system tumor and 3 more (5 arms), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoints: Incidence of Dose Limiting Toxicity at 8 weeks and Maximum Tolerated Dose at 1 year. Started Aug 2021; status: recruiting.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
Phase I portion
Dose escalation and PK expansion of repotrectinib + irinotecan + temozolomide.
Phase II, ALK-mutated neuroblastoma Cohort
Repotrectinib + irinotecan + temozolomide at RP2D (CLOSED).
Phase II, Molecularly defined DSRCT Cohort
Repotrectinib + irinotecan + temozolomide at RP2D.
Phase II, Exploratory Cohort
Repotrectinib + irinotecan + temozolomide at RP2D.
Phase II, DIPG Cohort
Repotrectinib monotherapy at pediatric RP2D.
03
Who it enrols
Pediatric and young adult patients (<= 30 years) with relapsed or refractory advanced/metastatic solid tumors or primary CNS tumors. Must have adequate organ function and performance status >= 50. Excludes patients with active infections, significant GI disease, or prolonged QTc.
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Endpoints
Primary
Incidence of Dose Limiting Toxicity
Maximum Tolerated Dose
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