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An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

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Trial Profile

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 28 May 2025

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At a glance

  • Drugs Abemaciclib (Primary) ; BBI-355 (Primary) ; Erlotinib (Primary) ; Futibatinib (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms POTENTIATE
  • Sponsors Boundless Bio

Most Recent Events

  • 23 May 2025 Status changed from recruiting to discontinued according to a Boundless Bio media release.
  • 07 Nov 2024 According to a Boundless Bio media release, in September, analytical validation data was presented at the European Society for Medical Oncology (ESMO) Congress for the companys proprietary ecDNA diagnostic ECHO (ecDNA Harboring Oncogenes). ECHO is currently being used as a clinical trial assay to determine ecDNA status of patients enrolled in the BBI-355 POTENTIATE trial.
  • 07 Nov 2024 According to a Boundless Bio media release, enrollment is proceeding in this Phase 1/2 POTENTIATE clinical trial. The company anticipates reporting initial clinical proof-of-concept data in the second half of 2025.

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