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

NCT ID NCT07535112

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 130 people

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

Started

Apr 2026

Expected to finish

Jul 2030

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.

Inclusion Criteria: * KRAS G12D mutated solid tumor * Participant must be ≥18 years old or the legal age of consent in the jurisdiction in which the study is taking place when signing the screening ICF * At least one measurable lesion as per RECIST v1.1. outside the CNS * Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1 * Male or Female: Contraceptive use by participant or participant's partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Life expectancy of at least 3 months in the opinion of the Investigator * Histologically/pathologically documented diagnosis of advanced/metastatic adenocarcinoma of the colon and rectum. * Adequate hematologic and end-organ function Exclusion Criteria: * Leptomeningeal disease or carcinomatous meningitis * Uncontrolled and/or active/symptomatic brain metastases. * Significant traumatic injury or major surgical procedure within 4 weeks of first dose of study intervention * Known hypersensitivity to any component of study intervention * Previous (within 3 years) or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the respective substudy. * Active infection requiring systemic anti-infective therapy within 14 days of first dose of study intervention * Known HIV infection * Active Hepatitis B virus (HBV) infection * Active Hepatitis C virus (HCV) infection; * Significant cardiac disorder * History of risk factors for torsade de pointes (TdP) (e.g., heart failure, family history of long QT syndrome) * Participants with inadequately managed diabetes as assessed by the Investigator * Toxicities from prior anticancer therapy, defined as not having resolved to Grade ≤1 or as specified in the respective substudy protocol as per NCI CTCAE v.6.0 with the following exceptions: Alopecia of any grade, Peripheral neuropathy Grade ≤2, Autoimmune endocrine disorders Grade ≤2 managed with stable endocrine replacement therapy * History of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis (unless it has resolved without sequelae without use of steroids), or any evidence of clinically-active pneumonitis/ILD * History of the following eye disorders: keratitis, ulcerative keratitis

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma

As listed by the trial registrant

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

Advanced/metastatic colorectal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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