What is the mechanism of action of this treatment?

The most common treatments for kidney cancer include tyrosine kinase inhibitors (TKIs) like sunitinib and cabozantinib, which block signals that promote cancer cell growth and angiogenesis. Immune checkpoint inhibitors such as nivolumab and pembrolizumab enhance the immune system's ability to recognize and destroy cancer cells by inhibiting proteins that suppress immune responses. Investigational agents like HC-5404-FU aim to establish a maximum tolerated dose and assess safety and efficacy, potentially offering new therapeutic options. These treatments are crucial for kidney cancer patients as they target specific pathways involved in tumor growth and immune evasion, potentially improving outcomes and providing personalized treatment options.

What side effects are associated with this type of intervention?

Common treatments for kidney cancer, such as sunitinib and sorafenib, often result in side effects including hypertension, hand-foot syndrome, rash, and fatigue. Sunitinib is associated with palmar-plantar erythrodysesthesia and increased risk of hypertension, while sorafenib can cause similar dermatologic and gastrointestinal toxicities. Immunotherapies like nivolumab may lead to immune-mediated adverse events such as colitis, hepatitis, and endocrinopathies. These treatments can also cause nephrotoxicity, leading to renal impairment or acute renal failure in some cases.

What prior FDA approvals exist?

Several FDA-approved treatments for kidney cancer, particularly renal cell carcinoma (RCC), include targeted therapies and immunotherapies. Notable targeted therapies include sunitinib, pazopanib, and cabozantinib, which inhibit multiple tyrosine kinases involved in tumor growth and angiogenesis. Immunotherapies such as nivolumab and pembrolizumab, which are checkpoint inhibitors, have also been approved for advanced RCC. These treatments aim to enhance the body's immune response against cancer cells. The investigational agent HC-5404-FU, being studied for its safety and efficacy in RCC and other solid tumors, aligns with these approaches by potentially offering a new targeted or immunotherapeutic option.

What other types of research exist?

Promising novel alternatives to HC-5404-FU for kidney cancer patients include: 1) Pembrolizumab plus Axitinib, which has shown improved survival rates in advanced RCC. 2) Nivolumab plus Ipilimumab, which has demonstrated efficacy in first-line treatment of advanced RCC. 3) Cabozantinib, which has been effective in advanced RCC, particularly in combination with other agents like Atezolizumab. 4) Lenvatinib plus Pembrolizumab, which has shown promising results in both treatment-naive and previously treated metastatic RCC patients.

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HC-5404-FU Dose Determination for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by HiberCell, Inc.

Eligibility Criteria Checklist

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

Must have

Be ≥18 years of age (male or female) at the time of consent

Have Eastern Cooperative Oncology Group performance status of 0 or 1 and sustained between screening and initiation of dosing on Day 1

Must not have

Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 18 months of last patient enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, HC-5404-FU, in patients with certain types of cancer. The goal is to find the highest safe dose by increasing the amount given over time. Patients are monitored closely for side effects and how their cancer responds.

Who is the study for?

Adults with certain solid tumors, including renal cell carcinoma and small cell lung cancer, who have had a maximum of five prior treatments for advanced disease can join this trial. They must have measurable lesions, good organ function, no severe allergies or conditions that could interfere with the study, and agree to use contraception.

What is being tested?

The trial is testing HC-5404-FU's safety at different doses in patients with specific cancers. Starting at 25 mg twice daily, doses will increase as tolerated to find the highest dose patients can take without serious side effects (MTD). The study includes regular monitoring and may expand into further phases.

What are the potential side effects?

Potential side effects are not detailed but typically include reactions related to drug tolerance levels such as fatigue, digestive issues, blood disorders. Specific side effects will be monitored closely as dosage increases.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have been diagnosed with HIV.

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I am currently being treated for an infection.

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I have serious heart problems, including unstable chest pain or a recent heart attack.

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I have an active case of tuberculosis.

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I have a chronic condition affecting my pancreas or gastrointestinal system.

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I have tested positive for COVID-19 with a PCR test.

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My cancer has spread to my brain or the membranes around my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 18 months of last patient enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 18 months of last patient enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 18 months of last patient enrolled for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determination of MTD of HC-5404-FU

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort 8 - 300 mgExperimental Treatment1 Intervention

300 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group II: Cohort 7 - 900 mgExperimental Treatment1 Intervention

900 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group III: Cohort 6 - 600 mgExperimental Treatment1 Intervention

600 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group IV: Cohort 5 - 400 mgExperimental Treatment1 Intervention

400 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group V: Cohort 4 - 200 mgExperimental Treatment1 Intervention

200 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group VI: Cohort 3 - 100 mgExperimental Treatment1 Intervention

100 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group VII: Cohort 2 - 50 mgExperimental Treatment1 Intervention

50 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Group VIII: Cohort 1 - 25 mgExperimental Treatment1 Intervention

25 mg capsules of HC-5404-FU administered orally twice a day with food or within 30 minutes of completing a meal of each 3-week treatment cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HC-5404-FU

2021

Completed Phase 1

~30

0 / 9Eligibility 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

The most common treatments for kidney cancer include tyrosine kinase inhibitors (TKIs) like sunitinib and cabozantinib, which block signals that promote cancer cell growth and angiogenesis. Immune checkpoint inhibitors such as nivolumab and pembrolizumab enhance the immune system's ability to recognize and destroy cancer cells by inhibiting proteins that suppress immune responses. Investigational agents like HC-5404-FU aim to establish a maximum tolerated dose and assess safety and efficacy, potentially offering new therapeutic options. These treatments are crucial for kidney cancer patients as they target specific pathways involved in tumor growth and immune evasion, potentially improving outcomes and providing personalized treatment options.