JZP341 for Advanced Cancer

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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests JZP341, a new drug, in patients with advanced or returning solid tumors that haven't responded to other treatments. It aims to see if the drug is safe, how it works in the body, and if it can shrink tumors.

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.

How does the drug JZP341 differ from other treatments for advanced cancer?

JZP341 is unique because it may involve a mechanism similar to JQ1, a BET-bromodomain inhibitor, which targets specific proteins involved in cancer growth and immune evasion, potentially offering a more targeted approach with less toxicity compared to traditional chemotherapy. ^{1 2 3 4 5}

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

JQ1, a BET-bromodomain inhibitor, inhibits human cancer growth and suppresses PD-L1 expression. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Crucial Role of AR-V7 in Enzalutamide-Resistance of Castration-Resistant Prostate Cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A specific JMJD6 inhibitor potently suppresses multiple types of cancers both in vitro and in vivo. [2022]

4. England pubmed.ncbi.nlm.nih.gov

First-in-human Phase I study of EZN-4176, a locked nucleic acid antisense oligonucleotide to exon 4 of the androgen receptor mRNA in patients with castration-resistant prostate cancer. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

JAG1 Intracellular Domain Enhances AR Expression and Signaling and Promotes Stem-like Properties in Prostate Cancer Cells. [2022]