Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2

Celcuity Inc.

Phase 1 mCRPC (gedatolisib + darolutamide): 66% six-month rPFS; no treatment-related discontinuations or Grade 3 hyperglycemia; Grade 2-3 stomatitis in 10.5% of patients.
Phase 2 HER2+ mBC (gedatolisib + trastuzumab-pkrb): ORR 43%, median PFS 6.0 months, median OS 24.7 months; no discontinuations due to treatment-related AEs; 2.3% Grade 3 hyperglycemia.
Protocol amended to explore additional gedatolisib doses in mCRPC Phase 1/1b; up to six patients per arm in three arms, then Phase 1b with up to 40 patients to determine RP2D.
No prophylaxis for stomatitis used in the mBC trial; data cut-off Feb 10, 2025; results presented at ASCO June 2025.

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