Lung CancerPhase 1NCT05485974
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
A Phase 1 study testing HBI-2438 in people with Lung Cancer and Non Small Cell Lung Cancer, run by HUYABIO International, LLC. at 14 sites in 2 countries.
Trial summary
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- HBI-2438
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 1 Aug 2022to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Must have failed or refused standard of care therapy, are not eligible for standard of care therapy, or cannot benefit from standard of care therapy, in the opinion of the Investigator
- At least 1 measurable target lesion that meets the definition of RECIST v1.1
- ECOG Performance Status of 0 or 1
- Demonstrate adequate organ function
- Expected survival time > 3 months in the opinion of the investigator
- Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption
Who cannot join
- History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled
- Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks
- Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first dose of HBI-2438; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher
- Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Pregnant or nursing
Show all 9Show fewer
- Prior treatment with any KRAS G12C inhibitors
- Any condition that required systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration
- Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Gabrail Cancer Center
Canton, Ohio, 44718
California Cancer Associates for Research and Excellence, Inc. (cCare)
Encinitas, California, 92024
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
The Oncology Institute of Hope and Innovation
Glendale, California, 91204
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805
The Oncology Institute of Hope and Innovation
Pasadena, California, 91105
BRCR Medical Center
Plantation, Florida, 33322
California Cancer Associates for Research and Excellence, Inc. (cCare)
San Marcos, California, 92069
The Oncology Institute of Hope and Innovation
Santa Ana, California, 92705
Sarcoma Oncology
Santa Monica, California, 90403
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603
The Oncology Institute of Hope and Innovation
Whittier, California, 90603
Puerto Rico1 site
Pan American Center for Oncology Trials (PanOncology Trials)
Rio Piedras, Puerto Rico, 00935
About this study
Official title: A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
Read the detailed description
A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation. The primary and secondary objectives are:
- To determine the MTD and recommended Phase 2 dose (RP2D) of HBI-2438 as an oral monotherapy for advanced solid tumors harboring KRAS G12C mutation.
- To characterize the PK of HBI-2438 in subjects with advanced malignant solid tumors harboring KRAS G12C mutation.
HBI-2438 is an orally administered KRAS G12C Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 44 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 150 to 1200mg. Once the MTD of RP2D is established, an additional 6-8 subjects with brain metastases will be enrolled into the expansion phase at that dose level.
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Cancer of Pancreas, Colon Cancer, Solid Tumor
- Being tested
- HBI-2438
- Keywords
- KRAS G12C, FIH
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-2438Drug
KRAS G12C Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | 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. Receives: Drug: HBI-2438 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD)
Safety endpoints: Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 36 months
adverse events (AEs), and serious adverse events (SAEs) overall
Safety endpoints: adverse events (AEs), and serious adverse events (SAEs) overall
Measured: Up to 36 months
Secondary outcomes (6)
maximum plasma concentration (Cmax)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Measured: Cycle 1 (21 days)
minimum plasma concentration (Cmin)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Measured: Cycle 1 (21 days)
Area Under the Curve (AUC)
Pharmacokinetic variables including Area Under the Curve (AUC)
Measured: Cycle 1 (21 days)
Pharmacokinetic variables including clearance
Pharmacokinetic variables including clearance
Measured: Cycle 1 (21 days)
Pharmacokinetic variables including serum half-life
Pharmacokinetic variables including serum half-life
Measured: Cycle 1 (21 days)
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including volume of distribution
Measured: Cycle 1 (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 Dose Escalation Design with Expansion
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Bessudo, MD, Principal investigator, California Cancer Associates for Research and Excellence, Inc. (cCare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485974
- Sponsor's protocol ID
- HBI-2438-101
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT05485974
- Acronym / sponsor ID
- HBI-2438-101
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Cancer of Pancreas, Colon Cancer, Solid Tumor
- Keywords
- KRAS G12C, FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
Detailed description
A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation. The primary and secondary objectives are:
- To determine the MTD and recommended Phase 2 dose (RP2D) of HBI-2438 as an oral monotherapy for advanced solid tumors harboring KRAS G12C mutation.
- To characterize the PK of HBI-2438 in subjects with advanced malignant solid tumors harboring KRAS G12C mutation.
HBI-2438 is an orally administered KRAS G12C Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 44 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 150 to 1200mg. Once the MTD of RP2D is established, an additional 6-8 subjects with brain metastases will be enrolled into the expansion phase at that dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 Dose Escalation Design with Expansion
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: HBI-2438HBI-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Must have failed or refused standard of care therapy, are not eligible for standard of care therapy, or cannot benefit from standard of care therapy, in the opinion of the Investigator
- At least 1 measurable target lesion that meets the definition of RECIST v1.1
- ECOG Performance Status of 0 or 1
Key exclusion criteria (9 listed)
- History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled
- Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks
- Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first dose of HBI-2438; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher
- Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-2438KRAS G12C Inhibitor | Drug | Dose Escalation and Expansion |
Primary outcome
To determine the maximum tolerated dose (MTD)
Time frame: Up to 36 months
Safety endpoints: Incidence of dose-limiting toxicities (DLTs)
adverse events (AEs), and serious adverse events (SAEs) overall
Time frame: Up to 36 months
Safety endpoints: adverse events (AEs), and serious adverse events (SAEs) overall
6 secondary outcomes
maximum plasma concentration (Cmax)
Time frame: Cycle 1 (21 days)
minimum plasma concentration (Cmin)
Time frame: Cycle 1 (21 days)
Area Under the Curve (AUC)
Time frame: Cycle 1 (21 days)
Pharmacokinetic variables including clearance
Time frame: Cycle 1 (21 days)
Pharmacokinetic variables including serum half-life
Time frame: Cycle 1 (21 days)
Pharmacokinetic variables including volume of distribution
Time frame: Cycle 1 (21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Bessudo, MD principal investigator
California Cancer Associates for Research and Excellence, Inc. (cCare)
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBI-2438 in people with Lung Cancer and Non Small Cell Lung Cancer, run by HUYABIO International, LLC. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerated dose (MTD) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.