GTB-5550 in Advanced Solid Tumors

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.

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