New hope for Hard-to-Treat colorectal cancer: targeted drug enters human trials

NCT ID NCT07535112

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug, BAY 3771249, that targets a specific cancer-driving mutation called KRAS G12D. It is for people with advanced or metastatic colorectal cancer who have this mutation and have tried other treatments. The drug is given alone or with another cancer drug, cetuximab. The study aims to find a safe dose and see if it can shrink tumors.

What this could mean

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

Active substance
BAY 3771249 (a drug that blocks the mutated KRAS G12D protein) and cetuximab (a cancer drug given by IV)
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced colorectal cancer that has a specific KRAS G12D mutation, especially those who have run out of other options.
What could go wrong
This is an early Phase 1 trial, so the drug may not prove safe or effective. Side effects are unknown, and the mutation is rare, so results may not apply to all patients.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Border Medical oncology - Albury Wodonga Regional Cancer Centre

    NOT_YET_RECRUITING

    Albury, New South Wales, 2640, Australia

  • Cabrini Health Oncology Research

    NOT_YET_RECRUITING

    Malvern, Victoria, 3144, Australia

  • Calvary Mater Hospital Newcastle - Oncology

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • City of Hope - Duarte Cancer Center

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

    NOT_YET_RECRUITING

    Roma, 00128, Italy

  • Ghent University Hospital | Drug Research Unit Department

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus

    NOT_YET_RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • Hospital Universitari Vall D Hebron | Oncologia

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Hm Sanchinarro | Oncologia

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Icahn School of Medicine at Mount Sinai - Oncology

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC

    NOT_YET_RECRUITING

    Stockholm, Stockholm County, 171 76, Sweden

  • Mayo Clinic - Cancer Center - Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85054, United States

  • NEXT Dallas - Oncology Department

    RECRUITING

    Irving, Texas, 75039, United States

  • National Cancer Center Singapore - Oncology Department

    RECRUITING

    Singapore, 168583, Singapore

  • National University Hospital Medical Centre

    NOT_YET_RECRUITING

    Singapore, 119074, Singapore

  • Nederlands Kanker Instituut

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Odense University Hospital - Oncology Department

    NOT_YET_RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Rigshospitalet - Kræftbehandling

    NOT_YET_RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • START | San Antonio

    NOT_YET_RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's

    NOT_YET_RECRUITING

    Denver, Colorado, 80218, United States

  • UC San Diego Health - Moores Cancer Center

    NOT_YET_RECRUITING

    San Diego, California, 92037, United States