New drug combo targets Hard-to-Treat cancers in early trial
NCT ID NCT07218003
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug called RNDO-564, alone or with pembrolizumab, in adults with advanced solid tumors (like bladder, lung, or breast cancer) that have stopped responding to standard treatments. The main goals are to check safety, find the best dose, and see if the drug shrinks tumors or slows their growth. About 149 participants will receive weekly infusions of RNDO-564, with some also getting pembrolizumab every three weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 149 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Carolina Biooncology
Huntersville, North Carolina, 28078, United States
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Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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START Center for Cancer Research
San Antonio, Texas, 78229, United States
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START Midwest
Grand Rapids, Michigan, 49546, United States
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START Mountain Region
West Valley City, Utah, 84119, United States
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Sarah Cannon Research Institute, LLD
Nashville, Tennessee, 37203, United States
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UCSF Medical Center
San Francisco, California, 94143, United States
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Yale Cancer Center
New Haven, Connecticut, 06510, United States
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