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A pivotal Phase 3 clinical trial of MO-03 in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma

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Trial Profile

A pivotal Phase 3 clinical trial of MO-03 in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2026

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At a glance

  • Drugs Clostridium butyricum M588 (Primary)
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms BIOFRONT
  • Sponsors Osel Inc

Most Recent Events

  • 20 Jan 2026 New trial record
  • 08 Jan 2026 According to Osel media release, company announced a clinical trial agreement with SWOG Cancer Research Network for a pivotal Phase 3 clinical trial of its lead oncology candidate, MO-03, in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma (mRCC).
  • 08 Jan 2026 According to Osel media release, the trial is slated for Q1 2026.

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