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HBI-2438 for Cancer with KRAS G12C Mutation
Study Summary
This trial is testing a new drug to see what dose is safe for people with cancer that has a specific gene mutation. They will also look at how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can swallow pills and don't have major stomach or intestine issues.I have brain metastases but haven't needed steroids for them in the last 4 weeks.I have not been treated with KRAS G12C inhibitors before.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.My cancer has a KRAS G12c mutation.I am fully active or can carry out light work.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I don't have any major side effects from cancer treatment, except for hair loss.My cancer has a KRAS G12C mutation.I am 18 years old or older.My organs are functioning well.You cannot have taken any experimental drugs or used experimental medical devices within 4 weeks before starting this study.Standard treatments haven't worked for me, or I can't take them.I haven't had another cancer in the last 3 years, or if I did, it's unlikely to come back.I have an autoimmune disease that is currently active or might come back.
- Group 1: Dose Escalation and Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 28 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
Is access to this medical trial still available for participants?
"As indicated on clinicaltrials.gov, this medical trial is actively seeking out participants; it was initially posted on August 1st 2022 and the last update occurred on November 15th of that same year."
What are the associated risks of taking HBI-2438?
"The safety of HBI-2438 was given a score of 1 because this is an early phase medical trial, meaning there is only limited data regarding its efficacy and safety."
How many people are currently participating in this medical research?
"The sponsor, HUYABIO International, LLC., requires 44 suitable participants in order to execute this trial. Alliance for Multispecialty Research, LLC located in Whittier and Innovative Clinical Research Institute (ICRI) situated in Santa Ana will both be utilized as sites for the research."
What is the current location count of this research study?
"The trial is presently recruiting at 12 sites, and participants can select the facility nearest to them in order to reduce transportation requirements. These include Whittier, Santa Ana, Pasadena and nine other cities."
How does this research endeavor aim to benefit patients?
"During the 36 month trial period, primary outcomes of interest include overall adverse events (AEs) and serious adverse events (SAEs). Secondary goals are to measure specific pharmacokinetic variables such as clearance rate, volume of distribution, and serum half-life."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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