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JZP898 + Pembrolizumab for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Histological or cytological diagnosis of advanced or metastatic solid tumor

Adult ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial will study if a new drug combo is safe & effective against advanced solid tumors.

Who is the study for?

Adults over 18 with advanced or metastatic solid tumors who have tried certain treatments without success can join. They need to be fairly active and healthy (ECOG score of 0-1), not pregnant, willing to use birth control, and able to provide tumor samples. People with severe allergies, recent cancer therapies or surgeries, autoimmune diseases needing steroids, CNS tumors, lung disease requiring steroids, suicidal behavior or significant heart issues cannot participate.Check my eligibility

What is being tested?

The trial is testing JZP898 alone and combined with Pembrolizumab in adults with tough-to-treat cancers. It's a first-in-human study looking at safety and how the body processes these drugs while checking for any signs that they might shrink the tumors.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to monoclonal antibodies like skin reactions, fatigue, fever; organ inflammation; infusion-related symptoms; as well as potential impacts on liver function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced or has spread to other parts of my body.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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 TEAEs and SAEs

Incidence of dose interruptions, discontinuation, and reductions due to TEAEs

Number of Participants with Dose Limiting Toxicities

+1 more

Secondary outcome measures

Changes in tumor immune cell profile in response to monotherapy and combination therapy as measured by gene expression (nanoString)

Disease Control Rate (DCR) As Assessed by the Investigator

Duration of Response (DoR) As Assessed by the Investigator

+15 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B Combination Expansion: JZP898 in combination with pembrolizumabExperimental Treatment2 Interventions

Group II: Part A2 Dose Exploration: JZP898 in combination with pembrolizumabExperimental Treatment2 Interventions

Group III: Part A1 Dose Exploration: JZP898 monotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor

248 Previous Clinical Trials

34,108 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,969 Total Patients Enrolled

Frequently Asked Questions

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

What safety measures have been taken to protect participants in the Part A1 Dose Exploration: JZP898 monotherapy trial?

"The safety profile of Part A1 Dose Exploration: JZP898 monotherapy is tentatively assessed at 1, given the Phase 1 nature of this study and limited data regarding efficacy."

Answered by AI

Is this research endeavor actively recruiting participants?

"Data on clinicialtrials.gov indicates that this trial is presently not recruiting; it was first posted in November 15th 2023, and last modified October 26th of the same year. In contrast to this trial, there are currently 2719 other studies searching for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

2023. "JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108050.

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