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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+InterventionalTreatment
Rondo 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

Non Small Cell Lung Cancer
Cervical Cancer
Head and Neck Squamous Cell Cancer
Triple Negative Breast Cancer (TNBC)
Urothelial Carcinoma Bladder
Gastroesophageal Junction (GEJ) Adenocarcinoma
Esophageal Squamous Cell Cancer
Gastric Cancer
Cancer
Solid Tumors (Phase 1)

Explore related trials

Breast CarcinomaCervical CarcinomaEsophageal Squamous Cell CarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmUrothelial Carcinoma

NCT07218003

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Carolina Biooncology

    Huntersville, North Carolinano site contact published

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinano site contact published

  • Fred Hutchinson Cancer Center

    Seattle, Washingtonno site contact published

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkno site contact published

  • Sarah Cannon Research Institute, LLD

    Nashville, Tennesseeno site contact published

  • START Center for Cancer Research

    San Antonio, Texasno site contact published

  • START Midwest

    Grand Rapids, Michiganno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Thomas Manley, MD · STUDY_DIRECTOR · Rondo Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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