This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.
Phase 1 will also include subjects with NTRK-amplified advanced or metastatic solid tumors or refractory EWSR1-WT1-fusion-positive DSRCTs.
Phase 1 is the dose-escalation portion of the study in which the evaluation of safety and tolerability and establishing the RP2D are primary objectives. A 3 + 3 design will be utilized.
Inclusions/Exclusions: NTRK-fusion-+, locally adv or metastatic solid tumor. NTRK-gene amplified, locally adv or met solid tumor (Phase 1 only). EWSR1-WT1-positive DSRCTs (Phase 1 only). Note: Subjects with any grade of malignant glioma previously treated with systemic therapy are eligible. ECOG 0-1. No HIV allowed.