drugset / Trial / NCT07541573

GTB-5550 in Advanced Solid Tumors

NCT07541573 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2026-04-08
Primary completion
2031-01
Completion
2032-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GTB-5550 Protein / enzyme biologic 90 ug Subcutaneous
Subject GTB-5550 Protein / enzyme biologic 270 ug Subcutaneous
Subject GTB-5550 Protein / enzyme biologic 900 ug Subcutaneous
Subject GTB-5550 Protein / enzyme biologic 2700 ug Subcutaneous
Subject GTB-5550 Protein / enzyme biologic 5400 ug Subcutaneous
Subject GTB-5550 Protein / enzyme biologic 9000 ug Subcutaneous

Indications