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HC-7366 for Advanced 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
Male subjects with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time their partner is breastfeeding throughout the study treatment and for 90 days after the final administration of study drug
Have not experienced >10% body weight loss in the previous 4 weeks
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 cancer drug to see what the maximum tolerated dose is, what the recommended Phase 2 dose is, and to evaluate its safety and how well it is tolerated when taken orally once a day. The trial will enroll 36 subjects with advanced solid tumors, with up to 15 additional subjects in the expansion phase. The study will be conducted in the United States at 3-5 sites.
Who is the study for?
This trial is for adults with advanced solid tumors, including specific cancers like head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and bladder cancer. Participants must have an acceptable performance status and organ function, agree to use contraception if of childbearing potential, and not have a history of certain diseases or be on immunosuppressive therapy.Check my eligibility
What is being tested?
HC-7366 is being tested in this study to find the highest dose patients can take without serious side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D). The trial involves oral dosing in escalating amounts up to 150 mg daily. It includes initial testing (Phase 1a) followed by expansion at a fixed dose (Phase 1b) specifically in renal cell carcinoma patients.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to HC-7366 during the trial. These could range from mild symptoms like nausea or fatigue to more severe issues depending on how well they tolerate the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 90 days after.
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I have not lost more than 10% of my body weight in the last month.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My hormone levels are normal or well-managed.
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I am 18 years old or older.
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-7366
Determination of Recommended Phase 2 dose of HC-7366
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
+5 moreSecondary outcome measures
Accumulation ratio based on AUC 0-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: Phase 1b Cohort 8 - Dose 2 Chosen for ExpansionExperimental Treatment1 Intervention
XX mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group II: Phase 1b Cohort 7 - Dose 1 Chosen for ExpansionExperimental Treatment1 Intervention
XX mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group III: Phase 1a Cohort 6 - 150 mgExperimental Treatment1 Intervention
150 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group IV: Phase 1a Cohort 5 - 125 mgExperimental Treatment1 Intervention
125 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group V: Phase 1a Cohort 4 - 75 mgExperimental Treatment1 Intervention
75 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group VI: Phase 1a Cohort 3 - 40 mgExperimental Treatment1 Intervention
40 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group VII: Phase 1a Cohort 2 - 20 mgExperimental Treatment1 Intervention
20 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Group VIII: Phase 1a Cohort 1 - 10 mgExperimental Treatment1 Intervention
10 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle
Find a Location
Who is running the clinical trial?
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,781 Total Patients Enrolled
HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
845 Total Patients Enrolled
Jose Iglesias, MDStudy DirectorConsultant Chief Medical Officer for HiberCell, Inc.
3 Previous Clinical Trials
334 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 90 days after.I have a chronic pancreas or gastrointestinal condition.I have kidney cancer with specific features.I have not lost more than 10% of my body weight in the last month.I am fully active or restricted in physically strenuous activity but can do light work.I will not donate sperm during or for 3 months after treatment ends.I have had lung inflammation or pneumonitis in the last year.I have no health issues that could affect the study's results.My organs are functioning well.I have cancer that has spread to my brain or spinal cord.I haven't had cancer treatment or major surgery in the last 2 weeks, or I've recovered from their side effects.I am currently being treated for an infection.I have an active hepatitis B or C infection.I have one of the specified cancers and have had 1-5 treatments for stage IV disease.I do not have an infection that would affect my participation in the study.I have an active case of tuberculosis.My kidney function is normal.I have a serious heart condition.I have a known history of HIV.I have another cancer that has gotten worse or needed treatment in the last 5 years.You have a history of serious autoimmune disease or organ transplant.I have taken a pregnancy test within the last 3 days and it was negative.I agree to use a condom with spermicide during and for 90 days after treatment.I have not taken steroids or immunosuppressants in the last 7 days.You have had retinitis or skin conditions that make you sensitive to light.My hormone levels are normal or well-managed.My blood counts are within a healthy range.Your blood clotting works normally on the first day of the study.Your serum albumin level is higher than 3 g/dL.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a Cohort 2 - 20 mg
- Group 2: Phase 1a Cohort 1 - 10 mg
- Group 3: Phase 1a Cohort 3 - 40 mg
- Group 4: Phase 1a Cohort 4 - 75 mg
- Group 5: Phase 1a Cohort 5 - 125 mg
- Group 6: Phase 1a Cohort 6 - 150 mg
- Group 7: Phase 1b Cohort 7 - Dose 1 Chosen for Expansion
- Group 8: Phase 1b Cohort 8 - Dose 2 Chosen for Expansion
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial populated by participants?
"The sponsor, Covance, necessitates 66 eligible participants to initiate this medical study. The trial will be conducted in various locations including the University of Texas M.D Anderson Cancer Center (Houston) and Sarah Cannon Research Institute/Tennessee Oncology (Nashville)."
Answered by AI
Has HC-7366 met the criteria for Food and Drug Administration clearance?
"Our team at Power evaluated the safety of HC-7366 as a 1 due to its current standing in Phase 1 trials, meaning there is limited data available regarding efficacy and security."
Answered by AI
Are there opportunities for individuals to participate in this clinical investigation?
"According to the clinicaltrials.gov database, this medical trial is actively recruiting subjects with its first posting on February 23rd 2022 and most recent edits taking place April 18th of that same year."
Answered by AI
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