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GTB-5550 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started2026-04-08
View on ClinicalTrials.gov ↗

Amendment history

2026-04-20
minor
Study Identification, Study Status v1
Study title-12 characters
Phase 1a/1b GTB-5550 in Advanced Solid Tumors
2026-04-14
minor
Original filing
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.
Trial Details
NCT Number NCT07541573
Lead Sponsor Masonic Cancer Center, University of Minnesota
Collaborators: GT Biopharma, Inc.
Conditions Tri-specific Killer Engager, Solid Tumor, Advanced Solid Tumor
Enrollment 175 participants
Start Date 2026-04-08
Primary Completion 2031-01 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-23