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Dose Level 1 - ZH9 for Bladder Cancer (PARADIGM-1 Trial)

Phase 1

Recruiting

Research Sponsored by Prokarium Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group Performance Status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months

Awards & highlights

PARADIGM-1 Trial Summary

This trial is being conducted to test the safety and effectiveness of a drug called ZH9 in patients with recurrent non-muscle invasive bladder cancer (NMIBC) who can receive treatment directly into the

Who is the study for?

This trial is for patients with recurrent non-muscle invasive bladder cancer (NMIBC) who are suitable for intravesical therapy. Specific details about inclusion and exclusion criteria were not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.Check my eligibility

What is being tested?

The study tests ZH9, a new treatment administered first through IVI (intravenous infusion) then orally. It's divided into three parts: assessing safety and dosage in Part 1, evaluating combined oral and IVI administration in Part 2, and further examining safety, dosing effects, and how well it works in Part 3.See study design

What are the potential side effects?

While specific side effects of ZH9 aren't listed here, common ones from similar treatments include reactions at the infusion site, gastrointestinal symptoms like nausea or diarrhea, potential allergic reactions to the drug components, fatigue or flu-like symptoms.

PARADIGM-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My bladder cancer has come back and was confirmed by a biopsy.

PARADIGM-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities

Secondary outcome measures

Change from baseline in systemic and local inflammatory markers in the bladder

Overall response rate and recurrence-free rate

Proportion of patients with cystectomy-free survival

+4 more

PARADIGM-1 Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Level 4 - ZH9Experimental Treatment1 Intervention

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group II: Dose Level 3 - ZH9Experimental Treatment1 Intervention

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group III: Dose Level 2 - ZH9Experimental Treatment1 Intervention

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

Group IV: Dose Level 1 - ZH9Experimental Treatment1 Intervention

Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prokarium LtdLead Sponsor

1 Previous Clinical Trials

46 Total Patients Enrolled

Josefin-Beate Holz, MDStudy DirectorProkarium Ltd

7 Previous Clinical Trials

928 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this trial?

"According to the information provided on clinicaltrials.gov, this particular study is no longer accepting candidates. The trial was originally posted on January 3rd, 2024 and last updated on December 12th, 2023. However, it's worth noting that there are currently 321 other active trials that are actively seeking participants at this time."

Answered by AI

Are individuals who are 18 years old or older eligible to participate in this recruitment for the clinical trial?

"Patients between the ages of 18 and 99 are eligible to enroll in this clinical trial. It's worth noting that there are also 12 studies available specifically for individuals under the age of 18, as well as 320 studies targeting patients over the age of 65."

Answered by AI

For which individuals is participation in this research study deemed appropriate?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of bladder cancer and fall between the ages of 18 and 99. The study has a maximum capacity to accept 24 participants in total."

Answered by AI

Has the Food and Drug Administration (FDA) officially granted approval for Dose Level 3 - ZH9?

"Based on the evaluation conducted by our team at Power, Dose Level 3 - ZH9 is assigned a safety rating of 1. This determination aligns with the early stage of the trial (Phase 1) where available data supporting both safety and efficacy is limited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

2024. "A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06181266.

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