GT Biopharma, Inc. (NASDAQ:GTBP) on Tuesday secured IND clearance from the U.S. Food and Drug Administration (FDA) to evaluate its novel therapeutic candidate, GTB-5550, in treating multiple myeloma.
Multiple myeloma is a rare type of blood cancer that develops in the plasma cells, which are a type of white blood cell found in the bone marrow.
The trial initiation is contingent upon timing and receipt of non-dilutive grant funding.
Cash balance as of September 15 is approximately $11 million, anticipated to provide sufficient cash runway into the third quarter of 2027.
Advancing To Clinical Trials
The upcoming Phase 1a/1b clinical study marks the first time a B7-H3-targeted TriKE therapy enters human trials for multiple myeloma.
The company designed this treatment for subcutaneous administration, a patient-friendly injection method that aims to extend the drug’s half-life compared to prior intravenous formulations.
Trial Structure And Patient Enrollment
Researchers will begin the study with a Phase 1a dose-escalation stage, enrolling patients who have undergone at least four prior lines of therapy for multiple myeloma.
The initial stage will evaluate up to six different dose cohorts to identify the maximum tolerated dose.
Following this dose escalation, the Phase 1b expansion cohort will enroll 25 patients treated at the identified maximum tolerated dose to further evaluate safety, tolerability, and preliminary anti-tumor activity.
Treatment Schedule And Monitoring
Medical staff will administer GTB-5550 via subcutaneous injection in the abdominal area on three non-consecutive days during the first two weeks of a four-week cycle. Patients will then rest without treatment for the remaining two weeks.
The protocol requires a minimum of two treatment cycles, with physicians performing disease reassessment through monoclonal protein and free light chain analysis on the 28th day of each round.
Patients maintaining stable disease can receive up to four total cycles. Meanwhile, individuals showing a partial response or better may continue treatment for up to one year.
The clinical team will follow all participants for 12 months from their first dose to determine progression-free survival and overall survival rates.
Phase 1 dose escalation basket trial with GTB-5550 in solid tumor patients continues to enroll, with an update anticipated in the fourth quarter of 2026.
GTBP Price Action: GT Biopharma shares were up 3.09% at $11.99 during premarket trading on Tuesday, according to Benzinga Pro data.
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