Trial Profile

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 16 Dec 2025

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At a glance

Drugs Pembrolizumab (Primary) ; RNDO 564 (Primary)
Indications Advanced breast cancer; Bladder cancer; Cervical cancer; Gastric cancer; Head and neck cancer; Male breast cancer; Non-small cell lung cancer; Oesophageal cancer; Solid tumours; Triple negative breast cancer; Urogenital cancer
Focus Adverse reactions; First in man
Sponsors Rondo Therapeutics

03 Dec 2025 According to a Rondo Therapeutics media release, Benjamin Garmezy is the principal investigatorof the trial.
03 Dec 2025 According to a Rondo Therapeutics media release, the first patient has been dosed in this trial.
24 Oct 2025 Planned initiation date changed from 27 Oct 2025 to 30 Oct 2025.

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