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ENROLLING BY INVITATION
NCT07218003
PHASE1

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

Sponsor: Rondo Therapeutics

View on ClinicalTrials.gov

Summary

The main goal of this study is to evaluate how safe and tolerable RNDO-564 is and to identify the best dose of RNDO-564 as a single agent and in combination with pembrolizumab. The study is focused on participants with certain solid tumors that are in an advanced stage and have certain tumor makers. This will be done by measuring the side effects that participants experience and how severe they are. Additionally, the study will evaluate how RNDO-564 moves into, through, and out of the body and how the treatment affects the body. The second goal of this study is to evaluate how well RNDO-564 works by itself or in combination with pembrolizumab at treating participants' cancer. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured. Participants will take RNDO-564 weekly on Days 1, 8 and 15 of a 21 day cycle. Participants in the combination arms will take RNDO-564 as described with pembrolizumab every 3 weeks.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

149

Start Date

2025-11-17

Completion Date

2029-03-31

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

RNDO-564

CD28 x Nectin-4 bispecific

DRUG

Pembrolizumab

Anti-PD-1 therapy

Locations (7)

START Midwest

Grand Rapids, Michigan, United States

Carolina Biooncology

Huntersville, North Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Sarah Cannon Research Institute, LLD

Nashville, Tennessee, United States

START Center for Cancer Research

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States