Phase 1/1b Study of RNDO-564 / Pembrolizumab in Tumours with Nectin-4 Expression
Research type
Research Study
Full title
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
IRAS ID
1013272
Contact name
Thomas Manley
Contact email
Sponsor organisation
Rondo Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The proposed study is an open-label phase 1/1b study of RNDO-564 in adult participants with relapsed refractory locally advanced or metastatic urothelial cancer and other solid tumours associated with Nectin-4 expression. The study is sponsored by Rondo Therapeutics.
New treatment options that are safe and effective in this patient population are needed and Rondo Therapeutics has developed RNDO-564. This study is the first time RNDO-564 will be tested in humans. The purpose of the study is to test the safety of RNDO-564 and how well it works alone and when used with another drug called pembrolizumab. Pembrolizumab is an anti-cancer medicine that is already approved for use by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Approximately 149 participants will take part in this study in the United States, Spain and the UK. Participants could receive up to 2 years of treatment.
The study has 4 stages:
1) Monotherapy Dose-Escalation Stage: This stage will test increasing doses of RNDO 564 given by itself to find the highest dose that can be safely given.
2) Monotherapy Dose-Optimisation Stage: This stage will test how well RNDO 564 works and find the best dose for future studies.
3) Combination Dose-Escalation Stage: This stage will test finding the right dose of RNDO-564 when combined with pembrolizumab. Participants will start at a dose level just below the highest safe dose found in earlier tests of RNDO-564 alone.
4) Combination Dose-Optimisation Stage: This stage will test to confirm the safety and see how well the combination of RNDO 564 and pembrolizumab work against tumours. This stage is also to find the best combination dose for future studies.The study will involve the following assessments: collection of demographics / medical history, physical exams, vitals, ECOG performance status, ECG, blood / urine samples, tumour tissue biopsy (if required), CT/MRI and bone scans (if required).
REC name
Wales REC 1
REC reference
26/WA/0120
Date of REC Opinion
9 Jul 2026
REC opinion
Further Information Favourable Opinion