RNDO-564 + Pembrolizumab for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called RNDO-564, both alone and with pembrolizumab, for individuals with advanced solid tumors, including certain bladder cancers. The main goal is to assess the safety of RNDO-564 and determine the optimal dose by monitoring side effects. Researchers also aim to evaluate the treatment's effectiveness by measuring if and how long it can halt cancer growth or spread. Participants should have advanced cancer that hasn't responded to standard treatments, including types like urothelial cancer or non-small cell lung cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RNDO-564 has promising safety results in early studies. Designed to attack cancer cells by targeting specific markers, it helps protect healthy cells and may reduce side effects.
Less information exists about the safety of using RNDO-564 with pembrolizumab. However, pembrolizumab is already approved for treating other cancers, so its safety profile is well understood. The goal of combining both drugs is to improve treatment effectiveness.
This trial is in an early stage and primarily aims to identify any side effects and determine the safest dose levels for RNDO-564, both alone and with pembrolizumab. This phase is crucial to ensure the treatment's safety for people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about RNDO-564, especially when combined with pembrolizumab, because it offers a potential breakthrough in treating bladder cancer. Unlike standard treatments like chemotherapy and immune checkpoint inhibitors, RNDO-564 may introduce a novel mechanism of action targeting cancer cells more precisely, potentially enhancing the immune response. This unique approach could lead to more effective and less toxic treatments compared to current options, which often have significant side effects. By optimizing dose levels both as a single agent and in combination with pembrolizumab, this treatment aims to boost efficacy and patient outcomes, offering hope for those with bladder cancer.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
This trial will evaluate RNDO-564, a new type of antibody, both as a single agent and in combination with pembrolizumab for bladder cancer. Studies have shown that RNDO-564 can stop tumors from growing in mice, both alone and when combined with pembrolizumab. Pembrolizumab is already known to help some bladder cancer patients live longer. The combination of RNDO-564 with pembrolizumab might strengthen the body's immune response against tumors. Early results in animals are promising, suggesting this combination could be a powerful new way to treat cancer.36789
Who Is on the Research Team?
Thomas Manley, MD
Principal Investigator
Rondo Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced-stage solid tumors, including various cancers like lung, breast, and bladder cancer. Participants must have tumors associated with Nectin-4 to qualify. Specific inclusion and exclusion criteria details are not provided but typically involve health status and prior treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RNDO-564 weekly on Days 1, 8, and 15 of a 21-day cycle, with pembrolizumab every 3 weeks in combination arms
End of Treatment
End of treatment visit to assess participant's response and any adverse events
Safety Follow-up
Safety follow-up visit to monitor adverse events and participant's health status
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- RNDO-564
Trial Overview
The study tests RNDO-564 alone or combined with Pembrolizumab in treating certain solid tumors. It aims to find the safest dose by observing side effects severity and how the body processes the drugs. The effectiveness will be measured by participants' response rate and tumor growth control.
How Is the Trial Designed?
15
Treatment groups
Experimental Treatment
Single Agent Dose Optimization - Dose Level 2
Single Agent Dose Optimization - Dose Level 1
Single Agent Dose Level 9
Single Agent Dose Level 8
Single Agent Dose Level 7
Single Agent Dose Level 6
Single Agent Dose Level 5
Single Agent Dose Level 4
Single Agent Dose Level 3
Single Agent Dose Level 2
Single Agent Dose Level 1
Combination Dose Optimization - Dose Level 2
Combination Dose Optimization - Dose Level 1
Combination Dose Escalation- Dose Level 1
Combination Dose Escalation - Dose Level 2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rondo Therapeutics
Lead Sponsor
Citations
A novel CD28 x Nectin-4 costimulatory bispecific antibody ...
In vivo, RNDO-564 alone and in combination with an anti-PD-1 mAb resulted in dose-dependent tumor growth inhibition in signal 1-proficient ...
Potency-optimized CD28-activating bispecific antibody for the ...
Tumor-bearing syngeneic mouse models confirmed the in vivo efficacy of RNDO-564, demonstrating significant tumor regression both as a single ...
Immune-Stimulants and Immune Modulators
In vivo, RNDO-564 alone resulted in significant tumor growth inhibition in signal 1 proficient syn- geneic models, indicating potential for monotherapy ...
4.
synapse.patsnap.com
synapse.patsnap.com/article/rondo-therapeutics-shares-preclinical-data-on-new-cd28-x-nectin-4-bispecific-antibody-for-advanced-bladder-cancer-at-asco-guRondo Therapeutics Shares Preclinical Data on New ...
The preclinical results for RNDO-564 are promising, showing strong anti-tumor activity both in vivo and in vitro, even in models resistant to ...
5.
bioworld.com
bioworld.com/articles/714933-rondo-therapeutics-reports-cd28-x-nectin-4-bispecific-antibody-for-bladder-cancerRondo Therapeutics reports CD28 x Nectin-4 bispecific ...
Half of the patients with muscle-invasive bladder cancer develop metastases ending with survival rates of less than 10% at 5 years after ...
NCT07218003 | A Phase 1/1b of RNDO-564 Single Agent ...
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 ...
Rondo Therapeutics Publishes Preclinical Data on RNDO ...
RNDO-564 is designed to deliver safe and robust tumor killing activity in Nectin-4 positive tumors.
939 A novel CD28 x Nectin-4 costimulatory bispecific ...
RNDO-564 has an affinity tuned CD28 arm, with potent anti-tumor activity and lack of super-agonism that mediates specific and signal 1 dependent ...
Rondo Therapeutics Presents Preclinical Data at ASCO ...
In preclinical studies, RNDO-564 demonstrated robust anti-tumor activity in vivo and in vitro, including in an antibody drug conjugate (ADC)- ...
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