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NCT07535112 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation
A Phase 1 study, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT07535112 is a Phase 1 study that is actively recruiting participants, run by Bayer. The registered enrollment target is 130 participants.
The verdict
NCT07535112, a Phase 1 study, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have advanced or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS. Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon) or the rectum (the section at the end of the bowel). When CRC spreads to other parts of the body, it is called advanced or metastatic CRC. Some people with CRC have the G12D mutation in the KRAS protein. This mutation is linked to a poorer outlook and fewer treatment options. Currently, there are no approved treatments that specifically target this mutation. KRAS is a protein that helps control how cells grow and divide. When it is mutated, it can cause cells to grow uncontrollably, leading to cancer. 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 can be given alone or together with another drug called cetuximab. 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 it can help shrink or control tumors in people with advanced or metastatic CRC that has the KRAS G12D mutation. The study will also look at how BAY 3771249 works when given alone or with cetuximab, especially in people who have already tried other treatments for their cancer. Researchers will measure, among others: The number and seriousness of health problems (adverse events) after receiving BAY 3771249. The number of participants who experience a dose-limiting side effect (DLT) at each dose level. The number of participants whose tumors shrink or disappear (overall response rate, ORR) as measured by standard criteria. How much of the drug is in the blood over time (AUC) and the highest amount in the blood (Cmax). Some participants will receive BAY 3771249 alone (monotherapy), and others will receive BAY 3771249 with cetuximab (com
Interventions
- DRUG Cetuximab
- DRUG BAY 3771249
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2026-04-07 |
| Est. Completion | 2030-07-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07535112
The ClinicalTrials.gov registry entry for NCT07535112 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT07535112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07535112 about?
NCT07535112 is a clinical study titled "A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation". Researchers are looking for a better way to treat people who have advanced or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS. Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon) or the rectum (the section ...
What is the current status of trial NCT07535112?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2026-04-07. Estimated completion is 2030-07-09.
What interventions are being tested in trial NCT07535112?
The interventions under investigation include: Cetuximab (DRUG), BAY 3771249 (DRUG).
Who is sponsoring clinical trial NCT07535112?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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