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

NCT ID NCT05163028

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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