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New drug HBI-2376 targets Hard-to-Treat cancers in early trial

NCT ID NCT05163028

Disease control Sponsor: HUYABIO International, LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tests a new oral drug called HBI-2376 in about 42 adults with advanced solid tumors (like lung, colon, or pancreatic cancer) that have KRAS or EGFR mutations and have stopped responding to standard treatments. The main goals are to find a safe dose and understand how the drug moves through the body. It is not yet known if the drug will shrink tumors or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HBI-2376 (a SHP2 inhibitor drug)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that have KRAS or EGFR mutations and have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 42 participants, focused on safety and dosing, not on proving the drug works. Many drugs fail at this stage, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

cancer colonic neoplasm colorectal cancer colorectal neoplasm malignant colon neoplasm malignant pancreatic neoplasm neoplasm non-small cell lung carcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Cancer of colon Cancer of pancreas Colorectal cancer Non-small cell lung cancer Pancreatic cancer Solid tumor

Contacts and locations

Locations

  • BRCR Medical Center

    Plantation, Florida, 33322, United States

  • California Cancer Associates for Research and Excellence, Inc. (cCare)

    Encinitas, California, 92024, United States

  • California Cancer Associates for Research and Excellence, Inc. (cCare)

    San Marcos, California, 92069, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Orlando Health, Inc.

    Orlando, Florida, 32806, United States

  • Pan American Center for Oncology Trials (PanOncology Trials)

    Rio Piedras, Puerto Rico, 00935, Puerto Rico

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Sarcoma Oncology

    Santa Monica, California, 90403, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.