> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-1b-of-rndo-564-single-agent-or-in-combination-with-98af17b9-b62c-4dde-b9ce-185a27ebb012 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Participants 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Lead sponsor Rondo Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Start date 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Dates **Completion date** 2029-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **First posted** 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Registry last updated** 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Primary completion date** 2029-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Start date** 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Size and sites **Participants** 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Planned participants** 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Lead sponsor** Rondo Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Identifiers **Registry ID** NCT07218003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **ClinicalTrials.gov ID** NCT07218003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Outcomes ### Primary outcomes 1. 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 Timeframe: From Day 1 to 90-days post last dose • Type, frequency, and severity of adverse events (AEs) 2. Dose Optimization Arms: • Identify one or more recommended Phase 2 doses (RP2D) Timeframe: From Day 1 up to 24 months To evaluate the totality of data ### Secondary outcomes 1. All Arms: To evaluate serum concentrations at specified timepoints of RNDO-564 as a single agent or in combination with pembrolizumab Timeframe: From Day 1 up to 25 months (inclusive of 30 day safety follow-up) 2. All Arms: Proportion of participants that develop anti-drug antibodies to RNDO-564 Timeframe: Baseline (predose) up to 25 months (inclusive of 30 day safety follow-up) 3. All Arms: Evaluate the prevalence, incidence and impact of anti-drug antibodies to RNDO-564 Timeframe: From Baseline (predose) up to 25 months (inclusive of the 30 day safety follow-up). 4. All Arms: Objective Response Rate Among Participants Timeframe: percentage of participants from Day 1 until the date of the first documented partial response or complete response assessed up to 24 months 5. All Arms: Duration of Response Timeframe: Time between the first partial response or complete response and the date of first documented progression or date of death, whichever came first, assessed up to 24 months 6. All Arms: Median Progression Free Survival Time Among Participants Timeframe: The number of months from Day 1 until the date of first documented progression or date of death, whichever came first, assessed up to 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Sites - UCSF Medical CenterSan Francisco, United States - Yale Cancer CenterNew Haven, United States - START MidwestGrand Rapids, United States - Memorial Sloan Kettering Cancer CenterNew York, United States - Carolina BiooncologyHuntersville, United States - Carolina Urologic Research CenterMyrtle Beach, United States - Sarah Cannon Research Institute, LLDNashville, United States - MD Anderson Cancer CenterHouston, United States - START Center for Cancer ResearchSan Antonio, United States - START Mountain RegionWest Valley City, United States - Fred Hutchinson Cancer CenterSeattle, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218003) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Rondo Therapeutics](https://trialight.com/data/company/rondo-therapeutics-1608a8d7-8bb7-4b49-a84f-d16baa635524.md) ### Conditions (9) - [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) - [Urinary bladder neoplasm](https://trialight.com/data/condition/urinary-bladder-neoplasm-269fb796-5527-5895-bad6-63dc153c3401.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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