JZP815 for Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Jazz Pharmaceuticals

Must not be taking: CYP3A4 inducers/inhibitors, PPIs, H2 antagonists

Disqualifiers: Uncontrolled brain metastases, Active infections, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing JZP815, a new drug, in patients with advanced or metastatic solid tumors that have specific genetic changes. The drug works by blocking signals that promote cancer growth.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong or moderate inducers or inhibitors of CYP3A4, at least 4 weeks before starting the study. You also need to stop using proton pump inhibitors and histamine-2 receptor antagonists at least 2 weeks before the first dose. If you are on cancer-directed therapy, a washout period of 28 days or 5 half-lives is required.

How is the drug JZP815 different from other cancer treatments?

JZP815 is unique because it targets the JNK signaling pathway, which is involved in cell growth and cancer progression. This pathway is not commonly targeted by existing cancer treatments, making JZP815 a novel approach for potentially inhibiting cancer cell proliferation and metastasis. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

Adults with advanced or metastatic solid tumors that have changes in the MAPK pathway can join this trial if they've tried all standard treatments without success, are not pregnant or breastfeeding, agree to use effective contraception, and have a life expectancy of at least 12 weeks. They must be able to undergo tumor biopsies and have good organ function.

Inclusion Criteria

A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 3 days before the first dose of study intervention

Expected life expectancy of at least 12 weeks

I am 18 years old or older.

Exclusion Criteria

I do not have any severe or uncontrolled health conditions.

I have not had any cancer other than non-spreading skin cancer, early-stage prostate cancer with low PSA, or in-situ cancers in the last 2 years.

I have serious heart issues, including recent stroke or heart attack.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration (Part A)

Characterize the safety and tolerability of JZP815, assess pharmacokinetics, and determine a recommended phase 2 dose

8-12 weeks

Multiple visits for dosing and PK assessments

Expansion (Part B)

Further investigate the recommended phase 2 dose and assess antitumor activity in various subsets of disease

12-24 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• JZP815 (MAPK Pathway Inhibitor)

Trial Overview The study is testing JZP815 oral capsules for safety, proper dosing levels, and initial effectiveness against tumors. It's an early-phase trial (phase 1) focusing on patients whose cancers involve alterations in the MAPK pathway.

Participant Groups

Group I: Expansion (Part B): JZP815 Experimental Treatment 1 Intervention

Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).

Group II: Dose Exploration (Part A): JZP815 Experimental Treatment 1 Intervention

Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Chicago, IL

Florida Cancer Specialists - Lake Nona Orlando, FL

Florida Cancer Specialists - Sarasota Sarasota, FL

Sidney Kimmel Cancer Center Philadelphia, PA

More Trial Locations

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Patients Recruited

35,100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cytoplasmic inhibitor of the JNK signal transduction pathway. Dickens, M., Rogers, JS., Cavanagh, J., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The expression of the insulin-like growth factor II, JIP-1 and WT1 genes in porcine nephroblastoma. Engström, W., Granerus, M.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAPK8IP2 is a potential prognostic biomarker and promote tumor progression in prostate cancer. Zeng, Z., He, W., Jiang, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression and effects of JMJD2A histone demethylase in endometrial carcinoma. Wang, HL., Liu, MM., Ma, X., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jazf1 promotes prostate cancer progression by activating JNK/Slug. Sung, Y., Park, S., Park, SJ., et al.[2019]

References

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

A cytoplasmic inhibitor of the JNK signal transduction pathway. [2019]

2. Greece pubmed.ncbi.nlm.nih.gov

The expression of the insulin-like growth factor II, JIP-1 and WT1 genes in porcine nephroblastoma. [2010]

3. England pubmed.ncbi.nlm.nih.gov

MAPK8IP2 is a potential prognostic biomarker and promote tumor progression in prostate cancer. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Expression and effects of JMJD2A histone demethylase in endometrial carcinoma. [2019]

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

Jazf1 promotes prostate cancer progression by activating JNK/Slug. [2019]