Non Small Cell Lung CancerPhase 1NCT05163028
A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations
A Phase 1 study testing HBI-2376 in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by HUYABIO International, LLC. at 12 sites in 2 countries.
Trial summary
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- HBI-2376
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 13 Dec 2021to 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 or EGFR mutations diagnosed by histology or cytology
- Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
- 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
- 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
- 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 SHP2 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
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Gabrail Cancer Center
Canton, Ohio, 44718
City of Hope
Duarte, California, 91010
California Cancer Associates for Research and Excellence, Inc. (cCare)
Encinitas, California, 92024
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Providence Medical Foundation
Fullerton, California, 92835
Orlando Health, Inc.
Orlando, Florida, 32806
BRCR Medical Center
Plantation, Florida, 33322
California Cancer Associates for Research and Excellence, Inc. (cCare)
San Marcos, California, 92069
Sarcoma Oncology
Santa Monica, California, 90403
UCLA Hematology/Oncology
Santa Monica, California, 90404
Texas Oncology - Tyler
Tyler, Texas, 75702
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-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
Read the detailed description
A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are:
- To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations
- To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations
HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 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 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects will be enrolled into the expansion phase at that dose level.
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor, Cancer, Cancer of Pancreas
- Being tested
- HBI-2376
- Keywords
- KRAS, EGFR, SHP2, FIH
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-2376Drug
SHP2 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose. Receives: Drug: HBI-2376 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations.
Safety endpoints: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) overall, by severity, by relationship to HBI-2376, and those that led to discontinuation of HBI-2376
Measured: Up to 36 months
Secondary outcomes (6)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC)
Pharmacokinetic variables including Area Under the Curve (AUC)
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including clearance
Pharmacokinetic variables including clearance
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including serum half-life
Pharmacokinetic variables including serum half-life
Measured: Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution
Pharmacokinetic variables including volume of distribution
Measured: Cycle 1 (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start13 Dec 2021
- 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 Non Small Cell 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Salgia, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163028
- Sponsor's protocol ID
- HBI-2376-101
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2021
- 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-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations
- ClinicalTrials.gov ID
- NCT05163028
- Acronym / sponsor ID
- HBI-2376-101
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor, Cancer, Cancer of Pancreas
- Keywords
- KRAS, EGFR, SHP2, FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 2021 (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 or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
Detailed description
A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are:
- To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations
- To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations
HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 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 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects 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-2376HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 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 (7 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 or EGFR mutations diagnosed by histology or cytology
- Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
- 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
- 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-2376SHP2 Inhibitor | Drug | Dose Escalation and Expansion |
Primary outcome
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations.
Time frame: Up to 36 months
Safety endpoints: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) overall, by severity, by relationship to HBI-2376, and those that led to discontinuation of HBI-2376
6 secondary outcomes
Pharmacokinetic variables including maximum plasma concentration (Cmax)
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including minimum plasma concentration (Cmin)
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including Area Under the Curve (AUC)
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including clearance
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including serum half-life
Time frame: Cycle 1 (28 days)
Pharmacokinetic variables including volume of distribution
Time frame: Cycle 1 (28 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.
Ravi Salgia, MD principal investigator
City of Hope Medical Center
12 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-2376 in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by HUYABIO International, LLC. at 12 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 7 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 12 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) and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations. (time frame: Up to 36 months). 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.