Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
RNDO-564
CD28 x Nectin-4 bispecific
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