RecruitingPhase 1NCT07218003

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

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


Sponsor

Rondo Therapeutics

Enrollment

149 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called RNDO-564, either alone or combined with pembrolizumab (an immunotherapy), in people with advanced cancers including bladder cancer, lung cancer, head and neck cancer, cervical cancer, stomach cancer, esophageal cancer, and triple-negative breast cancer. These are cancers with a specific protein (called Nectin-4) that the drug targets. **You may be eligible if...** - You have advanced or metastatic bladder (urothelial) cancer, squamous cell lung cancer, head and neck cancer, cervical cancer, gastric cancer, esophageal cancer, or triple-negative breast cancer - Your cancer has continued to grow despite standard treatments - You are well enough to tolerate cancer therapy **You may NOT be eligible if...** - You have untreated or uncontrolled cancer that has spread to the brain - You have significant nerve damage (peripheral neuropathy) above Grade 2 - You have had certain prior treatments that may interfere - You have serious heart, lung, liver, or kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRNDO-564

CD28 x Nectin-4 bispecific

DRUGPembrolizumab

Anti-PD-1 therapy


Locations(2)

Carolina Biooncology

Huntersville, North Carolina, United States

Sarah Cannon Research Institute, LLD

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07218003


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