JZP341 for Advanced Cancer

No longer recruiting at 7 trial locations

Overseen By Clinical Trial Disclosure & Transparency

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jazz Pharmaceuticals

Must not be taking: Asparaginase

Disqualifiers: CNS tumor, Cardiac disease, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment, JZP341, for individuals with advanced or spreading solid tumors (cancerous growths). The researchers aim to determine the optimal dose and assess its effectiveness for patients whose cancer has not responded to standard treatments. Ideal candidates for this trial have advanced cancer that has worsened despite other treatments, such as certain chemotherapy drugs. Participants will receive JZP341 on specific days within a 28-day cycle. 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JZP341 is likely to be safe for humans?

Research shows that JZP341 is being tested for safety in people with advanced cancer. This Phase 1 study marks the first time JZP341 is being tried in humans. Limited information exists about how people handle it or what side effects might occur. Phase 1 studies like this aim to find the right dose and identify any negative effects. Although specific data on JZP341 is not yet available, the trial's goal is to gather important safety information. As with any new treatment, risks may exist, and researchers closely monitor participants to manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JZP341 for advanced cancer because it offers a new way to tackle the disease with its unique mechanism of action. Unlike many traditional cancer treatments that often focus on killing cancer cells directly or inhibiting their growth, JZP341 targets specific pathways involved in cancer progression, potentially offering improved precision and reduced side effects. This targeted approach could mean better outcomes for patients with advanced cancer, especially those who have not responded well to existing therapies. Furthermore, JZP341 is administered on a bi-weekly schedule, which may offer a more convenient option for patients compared to some current treatments that require more frequent dosing.

What evidence suggests that JZP341 might be an effective treatment for advanced cancer?

Research shows that JZP341 is a modified form of asparaginase, a well-known cancer treatment drug. Studies have found that modifications to asparaginase can reduce immune reactions and enhance its effectiveness against cancer cells. Although specific data on JZP341's efficacy in treating advanced solid tumors is limited, its design suggests it could target cancer cells more effectively. Early tests have shown promise, indicating potential benefits for those whose cancer hasn't responded to other treatments. Overall, the unique features of JZP341 offer hope for treating advanced cancers. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with advanced or metastatic solid tumors, who have tried standard treatments without success or can't tolerate them. They must be in relatively good health otherwise, not planning to conceive, and willing to use contraception. People with serious heart conditions, certain infections like uncontrolled hepatitis B/C or HIV, pregnant or breastfeeding women, and those with unstable brain tumors are excluded.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My blood clotting, liver, pancreas, and kidney functions are all normal.

Life expectancy >12 weeks

Exclusion Criteria

I do not have an uncontrolled hepatitis infection or an immunodeficiency.

I have had a blood clot in my brain or keep getting blood clots.

I do not have any severe or uncontrolled health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding Phase

Determine the recommended phase 2 dose (RP2D), assess safety and pharmacokinetics/pharmacodynamics, and explore preliminary antitumor activity of JZP341

28 days per cycle

2 visits per cycle (Day 1 and Day 15)

Dose Expansion Phase

Evaluate clinical activity and further evaluate the safety of multiple doses of single-agent JZP341 at the RP2D

28 days per cycle

2 visits per cycle (Day 1 and Day 15)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JZP341

Trial Overview The trial is testing JZP341's safety and effectiveness on participants with tough-to-treat solid tumors that have spread. It involves adults who've exhausted other options. The study has two parts: finding the right dose of JZP341 and then seeing how well it works at that dose.

How Is the Trial Designed?

Group I: Dose Finding Phase: JZP341 Experimental Treatment 1 Intervention

Participants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.

Group II: Dose Expansion Phase: JZP341 Experimental Treatment 1 Intervention

Participants who will receive JZP341 at the RP2D established in the Dose Finding Phase on Day 1 and Day 15 of each 28-day cycle.

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05631327

A JZP341 Study in Adult Participants With Advanced or ... This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors.

2. withpower.com withpower.com/trial/phase-1-neoplasms-11-2022-8ef2b

JZP341 for Advanced Cancer · Info for Participants This trial tests JZP341, a new drug, in patients with advanced or returning solid tumors that haven't responded to other treatments.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-01392

A JZP341 Study in Adult Participants With Advanced or ... This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors. Eligibility Criteria. Inclusion Criteria.

4. jazzpharma.com jazzpharma.com/sites/jazzpharmaceuticals/files/2024-07/Jazz-Pharmaceuticals-Pipeline-Overview.pdf

Jazz Pharmaceuticals Pipeline Safety, tolerability and effectiveness, as well as how the body absorbs, distributes, and eliminates zanidatamab, are being evaluated in a three-part study on.

5. yorkspace.library.yorku.ca yorkspace.library.yorku.ca/bitstreams/cb9b523d-7a2a-4ade-bcb9-8cbe5238cd87/download

instrumental analysis of pasylated asparaginase, jzp-341, a ... Over the past 60 years, advances in biotechnology and recombinant DNA have allowed researchers to modify asparaginase to decrease its immunogenicity, improve ...

6. jazzpharma.com jazzpharma.com/sites/jazzpharmaceuticals/files/2024-02/Jazz-Pharmaceuticals-Pipeline-Overview_0.pdf

Jazz Pharmaceuticals Pipeline The Phase 4 prospective, multi-center observational study aims to collect safety and outcome data of lurbinectedin in adult participants with ES-SCLC previously ...

7. dana-farber.org dana-farber.org/clinical-trials/23-192

Phase 1, Open-Label, Dose-Finding, and Expansion Study ... This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors.