Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study, sponsored by Bayer.
NCT07535112 is a Phase 1 study that is actively recruiting participants, run by Bayer. The registered enrollment target is 130 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Applicable in Dosage escalation and expansion
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 |
What NCT07535112 shows while recruiting
NCT07535112 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT07535112 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07535112's enrollment target sits among peer trials
130 439th of 2000 higher than 1,550 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492036 · 130 participants
Long-Term Follow-Up of Recipient of Gene Transfer Research
- NCT01631617 · 130 participants · Phase 2
Effects of Treatments on Atopic Dermatitis
- NCT02368041 · 130 participants
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- NCT02604277 · 130 participants · NA
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI