NCT07218003
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
Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatmentRondo Therapeutics
~149 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:RNDO-564Pembrolizumab
At a glance
Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All Arms: - Proportion of participants with adverse events (including dose limiting toxicities) as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured over From Day 1 to 90-days post last dose
+1 more outcome measured
Conditions
Where it's being run
11 sites across 10 statesTexas2
California1
Connecticut1
Michigan1
New York1
North Carolina1
South Carolina1
Tennessee1
Study leadership
- Thomas Manley, MD · STUDY_DIRECTOR · Rondo Therapeutics
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
Exclusion
\> one prior Nectin-4 targeted agents 2. Peripheral neuropathy \> Grade 2 3. 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.
What this trial measures
- All Arms: - Proportion of participants with adverse events (including dose limiting toxicities) as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0From Day 1 to 90-days post last dose
• Type, frequency, and severity of adverse events (AEs)
- Dose Optimization Arms: • Identify one or more recommended Phase 2 doses (RP2D)From Day 1 up to 24 months
To evaluate the totality of data