drugset / Trial / NCT07541573
GTB-5550 in Advanced Solid Tumors
Phase 1
Recruiting
175 enrolled
Masonic Cancer Center, University of Minnesota
GT Biopharma, Inc. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |