GT919 / Gluetacs Therapeutics - LARVOL DELTA

GT919, a novel IKZF3/1 molecular glue degrader: Phase 1 safety and preliminary efficacy in relapsed or refractory multiple myeloma (R/R MM) (ASH 2025) - P | "Preclinical studies have demonstrated potentIKZF3/1 degradation at low nanomolar concentrations, leading to dual antitumor andimmunomodulatory activity in lenalidomide- or pomalidomide-refractory MM cell lines and xenograftmodels.Here, we present the result of the first-in-human study (CTR20231255) evaluating the safety,pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of GT919 in patients withrelapsed/refractory MM (R/R MM).MethodsThis is an open-label, multicenter Phase I study designed to evaluate the safety and tolerability of GT919in R/R MM patients. As of data, GT919 in combination with dexamethasone demonstrated a manageable safety profile andencouraging preliminary efficacy in R/R MM pts. Based on the recommendations from the Safety ReviewCommittee (SRC), the recommended Phase II dose (RP2D) for GT919 was established at 4 mg. Phase 2studies of the drug combination is planned to begin."

Clinical • P1 data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • Targeted Protein Degradation • Thrombocytopenia • CRBN • IKZF1 • IKZF3 • IL17RB