What side effects are associated with this type of intervention?

Common treatments for solid tumors that target cancer cell growth pathways or modulate the immune response, such as chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause fatigue, nausea, vomiting, hair loss, and increased risk of infection due to bone marrow suppression. Targeted therapies, which interfere with specific molecules involved in tumor growth, may lead to side effects like diarrhea, liver problems, skin rashes, and hypertension. Immunotherapies, which enhance the body's immune response against cancer cells, can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects vary in severity and frequency depending on the specific agents used and the individual patient's response.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors target cancer cell growth pathways or modulate the immune response. Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown efficacy in various solid tumors by enhancing the immune system's ability to fight cancer. Lenvatinib, a tyrosine kinase inhibitor, targets multiple growth factor receptors involved in tumor proliferation and angiogenesis. Cabozantinib, another tyrosine kinase inhibitor, has been approved for medullary thyroid cancer and renal cell carcinoma, targeting pathways critical for tumor growth and metastasis. These treatments exemplify the strategies of inhibiting cancer cell growth pathways and modulating immune responses, similar to the investigational drug JZP341.

What other types of research exist?

Promising alternatives to JZP341 for solid tumors include Pembrolizumab, Nivolumab, and Atezolizumab, which are immune checkpoint inhibitors showing efficacy in various solid tumors. Additionally, Cabozantinib, a tyrosine kinase inhibitor, has shown activity in medullary thyroid cancer and other solid tumors. These treatments target cancer cell growth pathways and modulate the immune response, making them viable options for patients in 2024.

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Unknown

JZP341 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 14

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for JZP341 aren't listed here, similar cancer drugs often cause fatigue, nausea, allergic reactions, blood clots or changes in blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nadir Serum Asparaginase Activity Response Rate (Dose Finding Phase)

Secondary study objectives

Nadir Serum Asparaginase Activity Response Rate (Dose Expansion Phase)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Finding Phase: JZP341Experimental Treatment1 Intervention

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

Group II: Dose Expansion Phase: JZP341Experimental Treatment1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often target cancer cell growth pathways or modulate the immune response. Targeted therapies, such as tyrosine kinase inhibitors, block specific enzymes and growth factor receptors involved in tumor cell proliferation and survival. Immunotherapies, including immune checkpoint inhibitors like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells by preventing the inhibition of T-cells. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially effective treatment options, often with fewer side effects compared to traditional chemotherapy.