Status:
RECRUITING
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
Lead Sponsor:
Rondo Therapeutics
Conditions:
Non Small Cell Lung Cancer
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The study will consist of four stages: 1) single agent dose escalation, 2) single agent dose optimization, 3) combination dose escalation and 4) combination dose optimization. Stages 1 and 3 are dose...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT07218003
Start Date
October 30 2025
End Date
March 31 2029
Last Update
October 24 2025
Active Locations (2)
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1
Carolina Biooncology
Huntersville, North Carolina, United States, 28078
2
Sarah Cannon Research Institute, LLD
Nashville, Tennessee, United States, 37203