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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 18 months of last patient enrolled
Awards & highlights
Study Summary
This trial is testing a new drug, HC-5404-FU, to see what the maximum tolerated dose is and to evaluate its safety and tolerability. The trial will enroll 36 subjects with specific types of cancer at 3-5 US sites. The starting dose is 25 mg twice daily, escalating to 50, 100, and 200 mg as safety allows. The trial will then expand to assess the most appropriate dose and tumor type(s) selected in Phase 1a as the most appropriate for further clinical development.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of MTD of HC-5404-FU
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related TEAEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Incidence of TEAEs leading to premature discontinuation
+4 moreSecondary outcome measures
Accumulation ratio based on AUC0 t (ARAUC) of plasma concentration
Apparent terminal elimination half life (t1/2) of plasma concentration
Apparent total clearance (CL/F) of plasma concentration
+13 moreTrial 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
Find a Location
Who is running the clinical trial?
HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
857 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,795 Total Patients Enrolled
Jose Iglesias, MDStudy DirectorConsultant Chief Medical Officer for HiberCell, Inc.
3 Previous Clinical Trials
346 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If it's safe and you agree, you are willing to have a tissue sample taken for testing.I am 18 years old or older.You have Type I diabetes and need insulin, or you have Type II diabetes that is not well controlled with an A1c level above 8%.I have a specific type of advanced cancer and have had 2-5 treatments for it.I agree to use birth control during and for 90 days after the study.I have been diagnosed with HIV.I will not donate sperm during and for 3 months after treatment.My organs are functioning well enough for treatment.I have another cancer that has been active or treated in the last 5 years.Your albumin level is 3 grams per deciliter or higher during screening.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 90 days after.I haven't had cancer treatment or major surgery in the last 2 weeks, or I've recovered from their side effects.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am currently being treated for an infection.I have a tumor that can be measured and was confirmed by a scan within the last 28 days.My side effects from previous treatments are mild, except for possible stable numbness or hair loss.I have serious heart problems, including unstable chest pain or a recent heart attack.I have had lung inflammation or pneumonitis in the last year.My kidney function is good as tested within the last 15 days.I have an active case of tuberculosis.I have not taken strong CYP3A4 drugs in the last 4 weeks.Your blood counts need to be normal within 15 days before starting the study drug.You have a current Hepatitis B or Hepatitis C infection.Your blood clotting ability is normal within 15 days before starting the study drug.I have a chronic condition affecting my pancreas or gastrointestinal system.I have a solid tumor cancer, but it's not a fast-growing type like pancreatic cancer.I will use effective birth control during and for 3 months after treatment.Your heart's electrical activity, called the QT interval, should be less than 450 milliseconds when adjusted for your heart rate.I have tested positive for COVID-19 with a PCR test.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to my brain or the membranes around my brain.Your doctor believes you will live for at least 3 more months.I have taken a pregnancy test within the last 72 hours and it was negative.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 7 - 900 mg
- Group 2: Cohort 8 - 300 mg
- Group 3: Cohort 1 - 25 mg
- Group 4: Cohort 2 - 50 mg
- Group 5: Cohort 3 - 100 mg
- Group 6: Cohort 4 - 200 mg
- Group 7: Cohort 5 - 400 mg
- Group 8: Cohort 6 - 600 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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