130 Participants NeededMy employer runs this trial

BAY 3771249 + Cetuximab for Colon Cancer

Recruiting at 20 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bayer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with advanced colorectal cancer (CRC) that has spread and features a specific mutation called KRAS G12D. Researchers aim to assess the safety and effectiveness of a drug called BAY 3771249, both alone and in combination with another drug, cetuximab. The goal is to determine if this treatment can shrink or control tumors. Suitable candidates for this trial have advanced CRC with the KRAS G12D mutation and have previously tried other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctors, as they can provide guidance based on your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BAY 3771249, a new drug under testing, targets a specific mutation called KRAS G12D. Studies have assessed its safety for humans. In earlier studies, over 20% of participants experienced common side effects such as diarrhea, nausea, vomiting, and tiredness. Researchers are also evaluating the safety and interaction of BAY 3771249 when combined with cetuximab, a cancer treatment drug. Cetuximab is generally well-tolerated, but its effectiveness varies with different KRAS mutations.

As this study begins, researchers are gradually increasing doses to determine a safe amount. Consequently, there is limited information on long-term safety. However, ongoing research focuses on understanding and managing potential risks. Participants are closely monitored for side effects to ensure their safety during the trial.12345

Why are researchers excited about this trial's treatments?

BAY 3771249 is unique because it offers a promising new approach to treating colon cancer. Unlike standard treatments like chemotherapy or targeted therapies, BAY 3771249 is being tested for its ability to work both alone and alongside cetuximab, a well-known cancer treatment. This combination could enhance the effectiveness of treatment by attacking the cancer cells through different pathways simultaneously. The excitement around BAY 3771249 comes from its potential to provide a more robust and possibly more effective option for patients with colon cancer.

What evidence suggests that BAY 3771249 and cetuximab could be effective treatments for advanced colorectal cancer with the KRAS G12D mutation?

Research has shown that BAY 3771249 is designed to block a specific protein called KRAS with the G12D mutation, potentially slowing or stopping cancer cell growth. This is crucial because KRAS mutations can lead to uncontrolled cell growth in cancers like colorectal cancer. Studies have found that BAY 3771249 effectively targets cells with the KRAS-G12D mutation. In this trial, participants will receive BAY 3771249 either as monotherapy or combined with cetuximab, a drug for certain cancers. This combination might be more effective for individuals with this specific mutation. While cetuximab has extended the lives of some patients with other KRAS mutations, its effectiveness with KRAS G12D remains under investigation.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic colon or rectal cancer that has a KRAS G12D mutation. Participants must have good organ function, at least one tumor outside the brain, be able to care for themselves, and not have certain infections, heart problems, recent major surgery, other cancers, or severe allergies to study drugs.

Inclusion Criteria

My blood counts and organ functions are within normal limits.
I am using birth control as required for clinical studies.
At least one measurable lesion as per RECIST v1.1. outside the CNS
See 5 more

Exclusion Criteria

Known hypersensitivity to any component of study intervention
I have not had a major injury or surgery in the past 4 weeks.
I have had another type of cancer within the past 3 years or at the same time as my current cancer.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosage Escalation

Participants receive BAY 3771249 at increasing doses to find the highest safe dose, either as monotherapy or in combination with cetuximab

Up to approximately 3 weeks

Dosage Expansion

Participants receive BAY 3771249 at the determined safe dose until disease progression or unacceptable toxicity

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label Extension (optional)

Participants may continue receiving BAY 3771249 if they benefit from the treatment after the study ends

What Are the Treatments Tested in This Trial?

Interventions

  • BAY 3771249
  • Cetuximab

Trial Overview

The study tests BAY 3771249 (a new drug targeting KRAS G12D) alone or combined with cetuximab in people whose colorectal cancer has spread and carries this mutation. The trial checks safety and effectiveness by gradually increasing doses and monitoring side effects and tumor response.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dosage expansionExperimental Treatment2 Interventions
Group II: Dosage escalationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

A Study to Learn More About How Safe BAY 3771249 is ...

The study drug, BAY 3771249, is designed to block the activity of KRAS with G12D mutation, which may help slow or stop the growth of cancer cells. BAY 3771249 ...

BAY 3771249: Uses, Side Effects, Dosing & 1 Clinical Trials

The study aims to evaluate the drug's ability to potentially slow the growth or spread of the cancer, improve patient outcomes, or manage ...

Bayer and Kumquat Biosciences initiate Phase I study with ...

KQB548 (BAY 3771249) is an investigational KRAS G12D inhibitor being developed to treat KRAS-mutated tumors, such as pancreatic, colorectal and ...

A Study to Learn More About How Safe BAY 3771249 is ...

~The main purpose of this study is to learn how safe BAY 3771249 is, how well people tolerate it, how the body processes the drug, and whether ...

Clinical efficacy of sequential treatments in KRASG12C ... - PMC

The presence of KRASG12C mutation in metastatic colorectal cancer (mCRC) correlates with poor outcome. Although different selective inhibitors are under ...

First patients enrolled in Ph 1 trial with KQB548 (BAY ...

We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can ...