GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors
GTB-5550 is now the 3rd TriKE® to enter the clinic and an expansion into a broader solid tumor opportunity, with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase
Company anticipates providing updates in 2H 2026 as enrollment progresses through dose escalation cohorts
Excerpt from the Press Release:
SAN FRANCISCO, CALIFORNIA, May 14, 2026 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today announced that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3.
“Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE® platform into the broader opportunity of treating patients with a variety of solid tumors. The ongoing Phase 1 progress with GTB-3650 in hematologic malignancies now gives us the confidence to advance the platform with GTB-5550 to target B7-H3, which is broadly expressed across many of the most common and difficult-to-treat solid tumor cancers. We look forward to providing updates on the trial’s progress throughout the second half of 2026.”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.
The Phase 1 trial with GTB-5550 will be the first nanobody TriKE® tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will focus primarily on enrolling prostate cancer patients and evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD).
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?