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
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Phase
Phase 1
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Recruitment status
Enrolling by invitation
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Participants
149
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Lead sponsor
Rondo Therapeutics
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Start date
2025-11-17
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Number of sites
11
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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.
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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
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-03-31
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First posted
2025-10-20
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Registry last updated
2026-06-11
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Primary completion date
2029-02-28
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Start date
2025-11-17
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Participants
149
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Participant count basis
Estimated
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Planned participants
149
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Protocol amendments
0
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Randomisation ratio
1:1
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Rondo Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07218003
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ClinicalTrials.gov ID
NCT07218003
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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

  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  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
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  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (9)

Targets (1)