Tests RNDO-564 alone or with pembrolizumab in advanced Nectin-4 cancers
Tests RNDO-564, alone or with pembrolizumab, in adults with advanced Nectin-4 tumors.
Key facts
- Who runs it
- Rondo Therapeutics
- Where
- Grand Rapids, Houston, Huntersville, Myrtle Beach, Nashville, New Haven, New York, San Antonio, San Francisco, Seattle, and West Valley City, United StatesSee the 11 sites
- Trial code
- Registry title
- 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
- Status
- Enrolling by invitation
- Phase
- Phase 1
- People taking part
- 149 people, planned
- Started
- 17 Nov 2025
- Expected to end
- 31 Mar 2029
- Type of study
- Interventional, 15 groups
- Treatments tested
- RNDO-564
- Pembrolizumab
- Record updated
- 11 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread solid tumors, such as urothelial (bladder), lung, head and neck, cervical, stomach, esophageal or triple negative breast cancer. Standard treatments must have stopped working, not been tolerated, or been declined.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Incurable, locally advanced or metastatic solid tumors with measurable disease (RECIST v1.1). Dose escalation: urothelial cancer, NSCLC, HNSCC, cervical, gastric or GEJ, esophageal cancer, or TNBC. Dose optimization: urothelial cancer only.
- Earlier treatment
- Standard treatments are no longer effective (the disease has progressed), are not tolerated, are not medically possible, or the person declined them. People with urothelial cancer may have had up to 2 earlier MMAE-containing treatments.
Main reasons for not taking part
- More than one earlier Nectin-4 targeted treatment
- Peripheral neuropathy (nerve damage) worse than Grade 2
- Current or past inflammatory skin disease, such as eczema or psoriasis, that needed or needs biologics or oral steroids
- Not enough organ function
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Eligible tumor types: Histologic documentation of incurable, locally advanced or metastatic solid tumors for which established standard systemic therapies are no longer effective (participant must have experienced progressive disease), are not tolerated, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds or have been declined by the participant, with these tumor subtypes:
- Monotherapy and Combination Dose Escalation Arms:
- RR la/mUC: Participants with urothelial cancer (transitional cell) with squamous differentiation or mixed cell types are eligible. Participants with upper tract disease, e.g., involving ureters, or renal pelvis, are eligible. Participants may have had up to 2 prior monomethyl auristatin E (MMAE)-containing therapies, assuming any existing peripheral neuropathy is Grade 2 or less
- NSCLC
- HNSCC
- CC
- GC and GEJ
- EC
- TNBC
- Dose Optimization (Monotherapy and Combination Arms):
- Limited to participants who have RR la/mUC,
- Participants may have had up to 2 prior MMAE-containing therapies, assuming any existing peripheral neuropathy is Grade 2 or less 2. Participants must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1; Adequate organ function
Who cannot take part
- For Nectin-4 targeted agents (approved or investigational); > one prior Nectin-4 targeted agents
- Participants with a history of, or with active, inflammatory skin disease, such as eczema, psoriasis that required or currently require biologics or oral steroids to control disease are ineligible
- Peripheral neuropathy > Grade 2
Where in United States
- START | MidwestGrand Rapids, United StatesEnrolling by invitation
- MD Anderson Cancer CenterHouston, United StatesEnrolling by invitation
- Carolina BiooncologyHuntersville, United StatesEnrolling by invitation
- Carolina Urologic Research CenterMyrtle Beach, United StatesEnrolling by invitation
- Sarah Cannon Research Institute, LLDNashville, United StatesEnrolling by invitation
- Yale Cancer CenterNew Haven, United StatesEnrolling by invitation
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesEnrolling by invitation
- START Center for Cancer ResearchSan Antonio, United StatesEnrolling by invitation
- UCSF Medical CenterSan Francisco, United StatesEnrolling by invitation
- Fred Hutchinson Cancer CenterSeattle, United StatesEnrolling by invitation
- START Mountain RegionWest Valley City, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 15 groups in the trial
- Single Agent Dose Level 1Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 2Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 3Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 4Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 5Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 6Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 7Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 8Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Level 9Treatment being tested
Treatment: RNDO-564
- Combination Dose Escalation- Dose Level 1Treatment being tested
Treatment: RNDO-564 and Pembrolizumab
- Combination Dose Escalation - Dose Level 2Treatment being tested
Treatment: RNDO-564 and Pembrolizumab
- Single Agent Dose Optimization - Dose Level 1Treatment being tested
Treatment: RNDO-564
- Single Agent Dose Optimization - Dose Level 2Treatment being tested
Treatment: RNDO-564
- Combination Dose Optimization - Dose Level 1Treatment being tested
Treatment: RNDO-564 and Pembrolizumab
- Combination Dose Optimization- Dose Level 2Treatment being tested
Treatment: RNDO-564 and Pembrolizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests RNDO-564 alone or with pembrolizumab in advanced Nectin-4 cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 June 2026