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MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy

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Trial Profile

MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs GTB 5550 (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Carcinoma; Head and neck cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Acronyms MT2025-14

Most Recent Events

  • 03 Feb 2026 According to a GT Biopharma media release, the company announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026.
  • 15 Jan 2026 According to a GT Biopharma media release, an initiation of a Phase 1 basket trial with GTB-5550 for multiple solid tumors is planned for 2026.
  • 15 Jan 2026 According to a GT Biopharma media release, the company announced the submission of investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 for the treatment of B7-H3 expressing solid tumor cancers.

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