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

NCT07218003 · tracked via the Priya Life Science USA tracker

Sponsor

Rondo Therapeutics

Phase

Phase 1

Started

2025-11-17

Last updated

2026-06-11

Condition(s) studied

Non Small Cell Lung CancerCervical CancerHead and Neck Squamous Cell CancerTriple Negative Breast Cancer (TNBC)Urothelial Carcinoma BladderGastroesophageal Junction (GEJ) AdenocarcinomaEsophageal Squamous Cell CancerGastric CancerCancerSolid Tumors (Phase 1)

Investigational drug(s) / intervention(s)

RNDO-564Pembrolizumab →

RNDO-564: CD28 x Nectin-4 bispecific

Pembrolizumab: Anti-PD-1 therapy

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 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: A. 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 B. 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 Exclusion Criteria: 1. For Nectin-4 targeted agents (approved or investigational) * \> 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.

Primary outcome measure(s)

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 — From 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

Trial sites (11)

Facility	City	Region
UCSF Medical Center	San Francisco	California
Yale Cancer Center	New Haven	Connecticut
START Midwest	Grand Rapids	Michigan
Memorial Sloan Kettering Cancer Center	New York	New York
Carolina Biooncology	Huntersville	North Carolina
Carolina Urologic Research Center	Myrtle Beach	South Carolina
Sarah Cannon Research Institute, LLD	Nashville	Tennessee
MD Anderson Cancer Center	Houston	Texas
START Center for Cancer Research	San Antonio	Texas
START Mountain Region	West Valley City	Utah
Fred Hutchinson Cancer Center	Seattle	Washington

On this site

📄 Keytruda (pembrolizumab) drug profile →

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A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors Active, not recruiting

AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies Active, not recruiting

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting

Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218003 on ClinicalTrials.gov ↗ ← All trials in the USA