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 · Phase 1
Conditions studied: 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)
In brief
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.
Key facts
- Study ID
- NCT07218003
- Run by
- Rondo Therapeutics
- People needed
- 149
- Starts
- 2025-11-17
- Expected to finish
- 2029-03-31
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Adequate organ function
You may not qualify if…
- For Nectin-4 targeted agents (approved or investigational)
- > one prior Nectin-4 targeted agents
- Peripheral neuropathy > Grade 2
- 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.
Where it is running
- UCSF Medical Center — San Francisco, California, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- START Midwest — Grand Rapids, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Carolina Biooncology — Huntersville, North Carolina, United States
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
- Sarah Cannon Research Institute, LLD — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- START Center for Cancer Research — San Antonio, Texas, United States
- START Mountain Region — West Valley City, Utah, United States
- Fred Hutchinson Cancer Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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