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Epigenetic Modulator

HBI-2438 for Cancer with KRAS G12C Mutation

Phase 1
Recruiting
Led By Alberto Bessudo, MD
Research Sponsored by HUYABIO International, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures
Advanced malignant solid tumors with KRAS G12C mutation- as determined by genetic testing
Timeline
Screening 28 days
Treatment Varies
Follow Up up to 36 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change called KRAS G12C mutation. They should be able to swallow pills, have at least one measurable tumor, and good organ function. They must not benefit from standard treatments and should not have serious heart issues or unresolved severe side effects from past cancer therapy.Check my eligibility
What is being tested?
The study tests different doses of HBI-2438 in patients to find the highest dose they can take without too many side effects (maximum tolerated dose) and to see how the body processes the drug (pharmacokinetic profile).See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on determining safe dosage levels, specific side effects of HBI-2438 are not listed but may include typical reactions seen with other cancer drugs such as nausea, fatigue, liver toxicity, and risk of infection.

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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My cancer has a KRAS G12C mutation.
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Standard treatments haven't worked for me, or I can't take them.
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I am fully active or can carry out light work.
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My organs are functioning well.
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I can swallow pills and don't have major stomach or intestine issues.

Timeline

Screening ~ 28 days
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 28 days for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the maximum tolerated dose (MTD)
adverse events (AEs), and serious adverse events (SAEs) overall
Secondary outcome measures
Area Under the Curve (AUC)
Pharmacokinetic variables including clearance
Pharmacokinetic variables including serum half-life
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention
HBI-2438 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6-8 patients will then be enrolled in the expansion cohort at the recommended dose.

Find a Location

Who is running the clinical trial?

HUYABIO International, LLC.Lead Sponsor
11 Previous Clinical Trials
935 Total Patients Enrolled
Alberto Bessudo, MDPrincipal InvestigatorCalifornia Cancer Associates for Research and Excellence, Inc. (cCare)
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

HBI-2438 (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05485974 — Phase 1
Lung Cancer Research Study Groups: Dose Escalation and Expansion
Lung Cancer Clinical Trial 2023: HBI-2438 Highlights & Side Effects. Trial Name: NCT05485974 — Phase 1
HBI-2438 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05485974 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Sarcoma Oncology
BRCR Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

~20 spots leftby Aug 2025