What side effects are associated with this type of intervention?

Common treatments for solid tumors, including investigational antitumor agents like ZX-4081, often have side effects such as nausea, vomiting, diarrhea, fatigue, and loss of appetite. Other potential side effects include hematologic toxicities like neutropenia, thrombocytopenia, and anemia, as well as liver function abnormalities and increased risk of infections. Patients may also experience skin reactions, mucositis, and general weakness. It is important to monitor these side effects closely and manage them in consultation with a healthcare provider.

What prior FDA approvals exist?

Several oral antitumor agents have received FDA approval for the treatment of advanced solid tumors. For instance, tyrosine kinase inhibitors (TKIs) like sunitinib and sorafenib are approved for renal cell carcinoma and hepatocellular carcinoma, respectively. Additionally, PARP inhibitors such as olaparib and niraparib are approved for ovarian cancer. Immunotherapies, including pembrolizumab and nivolumab, have also been approved for various solid tumors, including melanoma and non-small cell lung cancer. These treatments, like ZX-4081, aim to target specific pathways or enhance the immune response to combat tumor growth.

What other types of research exist?

Promising novel alternatives to ZX-4081 for solid tumor patients include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 therapy showing efficacy in various solid tumors. 2) Nivolumab (Opdivo) - another anti-PD-1 therapy with broad applications in solid tumors. 3) Atezolizumab (Tecentriq) - an anti-PD-L1 therapy used in combination with other agents for solid tumors. 4) Cabozantinib - a tyrosine kinase inhibitor effective in renal cell carcinoma and other solid tumors. 5) Lenvatinib - another tyrosine kinase inhibitor used in combination with pembrolizumab for various solid tumors.

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ZX-4081 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Nanjing Zenshine Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Metastatic or locally advanced solid tumor malignancies (breast cancer, urothelial cancer, ovarian cancer, melanoma, NSCLC, renal cell carcinoma, squamous cell cancer of the head and neck, colorectal cancer, and hepatocellular carcinoma) that has progressed on, is refractory to, intolerant to, or for which there is no curative standard of care therapy

Age ≥18 years at screening

Must not have

Patient has disease that is suitable for therapy administered with curative intent

Systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ZX-4081, taken regularly, in patients with advanced solid tumors. The goal is to see if it can safely reduce or stop tumor growth.

Who is the study for?

Adults (18+) with advanced solid tumors like breast, lung, or liver cancer that have worsened despite treatment can join. They must have measurable disease, good organ function, and a life expectancy over 12 weeks. Women who can get pregnant and men must agree to use birth control. People with untreated brain tumors, certain heart diseases, active infections including COVID-19 or hepatitis B/C with detectable virus are excluded.

What is being tested?

ZX-4081 is being tested in patients with various advanced cancers. This Phase 1 trial involves taking the drug orally twice daily in cycles of 28 days to check its safety, how well it's tolerated by the body (tolerability), how the body processes it (pharmacokinetics), its effects on tumor biology (pharmacodynamics), and initial effectiveness against cancer.

What are the potential side effects?

Specific side effects for ZX-4081 aren't listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies; organ-specific toxicity affecting liver or kidney function; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread or worsened despite treatment.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition can be treated with the goal of curing it.

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I am taking more than 10 mg/day of prednisone or its equivalent.

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My heart health is stable and I don't have severe heart issues or uncontrolled illnesses.

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I am currently being treated for an infection.

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My brain or spinal cord cancer has not been treated or is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine the recommended Phase 2 dose (RP2D) of ZX-4081

Safety and tolerability of ZX-4081

Secondary study objectives

Area under the plasma concentration of ZX-4081

Duration of Response (DOR)

Half-life of ZX-4081

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: ZX-4081 Expansion Dose LevelExperimental Treatment1 Intervention

Recommended Phase 2 Dose (RP2D) (to be determined) of ZX-4081 administered orally BID in a 28-day cycle

Group II: ZX-4081 Dose Level 6Experimental Treatment1 Intervention

10-times the SD of ZX-4081 administered orally BID in a 28-day cycle

Group III: ZX-4081 Dose Level 5Experimental Treatment1 Intervention

8-times the SD of ZX-4081 administered orally BID in a 28-day cycle

Group IV: ZX-4081 Dose Level 4Experimental Treatment1 Intervention

6-times the SD of ZX-4081 administered orally BID in a 28-day cycle

Group V: ZX-4081 Dose Level 3Experimental Treatment1 Intervention

4-times the SD of ZX-4081 administered orally BID in a 28-day cycle

Group VI: ZX-4081 Dose Level 2Experimental Treatment1 Intervention

2-times the SD of ZX-4081 administered orally BID in a 28-day cycle

Group VII: ZX-4081 Dose Level 1Experimental Treatment1 Intervention

Starting dose (SD) of ZX-4081 administered orally twice daily (BID) in a 28-day cycle

0 / 8Eligibility criteria met

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 include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells. Targeted therapies block specific molecules involved in tumor growth and progression, such as tyrosine kinase inhibitors. Immunotherapy, including checkpoint inhibitors like PD-1/PD-L1 inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for selecting the most appropriate treatment based on the tumor's characteristics and the patient's overall health.