GT Biopharma Inc. has announced continued progress in its Phase 1 clinical trial evaluating GTB-3650 in cancer patients. The trial has advanced to Cohort 4 at a dose level of 10 µg/kg/day. Six patients in Cohorts 1 through 3 have completed treatment, establishing the therapy's safety profile across escalating doses with no dose-limiting toxicities observed. The company indicated that the current dose level may be within the range where clinical efficacy is more likely, supported by encouraging immunological biomarker trends. The first-in-human Phase 1 protocol plans to enroll approximately 14 patients across seven dose-escalation cohorts, potentially reaching a maximum dose of 100 µg/kg/day. GT Biopharma anticipates providing its next comprehensive trial update in the first quarter of 2026. In addition, GT Biopharma is preparing to initiate human trials for GTB-5550, a therapy targeting B7H3, a protein found in several solid tumors. Regulatory submission for the GTB-5550 trial is expected in late December 2025 or January 2026. No final clinical results have been presented at this time.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. GT Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9616952) on December 24, 2025, and is solely responsible for the information contained therein.