NCT07218003Enrolling by invitationPhase 1
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 149 (estimated)
- First submitted
- 14 Oct 2025
- Start date
- 17 Nov 2025
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Rondo Therapeutics
- Diseases
- Triple-negative breast cancer, Bladder cancer, Cervical cancer, Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT07218003
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 149
- From 17 Nov 2025 to the primary completion date, 28 Feb 2029
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For Nectin-4 targeted agents (approved or investigational)
- \> one prior Nectin-4 targeted agents
Other illness
- 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.
Other
- Peripheral neuropathy \> Grade 2
Who the study is looking for
- 1\) 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.
- 3\. Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Carolina Biooncology Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Sarah Cannon Research Institute, LLD Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| START Center for Cancer Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSF Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.