Summit Therapeutics registers Phase 2/3 HARMONi-GU1 trial in urothelial carcinoma
Summit Therapeutics listed a new randomized study testing ivonescimab plus enfortumab vedotin against pembrolizumab plus enfortumab vedotin in metastatic urothelial cancer.
Summit Therapeutics' registry activity this week centers on one newly listed trial.
- Summit Therapeutics registered "HARMONi-GU1" (NCT07815665), a Phase 2/3 study of ivonescimab combined with enfortumab vedotin versus pembrolizumab combined with enfortumab vedotin in patients with previously untreated locally advanced or metastatic urothelial carcinoma. The trial is sponsored by Summit Therapeutics1 and is designed in two parts: a Phase 2 portion to evaluate safety and identify a recommended Phase 3 dose of ivonescimab plus EV, followed by a Phase 3 portion comparing ivonescimab at the recommended dose plus EV against pembrolizumab plus EV.1 The study is listed with an estimated start date of September 10, 2026, and estimated enrollment of 800 participants,1 with overall status recorded as recruiting.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.