NCT04901806

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors

A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor, Adult
• Brain Tumor, Primary
• Desmoplastic Small Round Cell Tumor

Interventions

Type	Name	Description
DRUG	PBI-200	PBI-200 will be administered orally over continuous 28-day cycles

Timeline

• Start date: 2021-07-20
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2021-05-26
• Last updated: 2024-03-28

Locations

42 sites across 11 countries: United States, Australia, Denmark, France, Germany, Hong Kong, Italy, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study