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Clinical Trial Summary

This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.


Clinical Trial Description

This is a first-in-human, 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 desmoplastic small round cell tumors (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. Once the RP2D has been established, two expansion cohorts will open to accrual, a Non-Brain Primary Tumor cohort and a Primary Brian Tumor cohort. Although this was intended to be a Phase 1/2 trial, the trial was terminated without proceeding to Phase 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04901806
Study type Interventional
Source Pyramid Biosciences
Contact
Status Terminated
Phase Phase 1
Start date July 20, 2021
Completion date July 26, 2023

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