Trials / Recruiting
RecruitingNCT05200442
A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer
A Phase 1b/2 Study of AVUTOMETINIB and Cetuximab in Participants With Advanced KRAS Mutated Colorectal Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Doctors leading this study hope to learn about the safety of combining the study drug VS-6766 with another drug called cetuximab in colorectal cancer. This study is for individuals who have advanced colorectal cancer and their cancer has progressed while getting previous treatment or individuals who cannot take/tolerate previous treatments. If you choose to participate, your time in this research will last up to 24 months.
Detailed description
The purpose of this research is to gather information on the safety and effectiveness of VS-6766 in combination with cetuximab. Doctors leading this study want to find out if combining two medications (cetuximab and VS-6766) is better or worse than the usual approach for the treatment of colorectal cancer. The usual approach for treating colorectal cancer after it progresses involves chemotherapies like Fluorouracil (5-FU), oxaliplatin, irinotecan and possibly a medication like bevacizumab. This study will instead combine cetuximab and VS-6766 to find out if the two medications can help people living with advanced colorectal cancers with certain mutations (differences) called KRAS mutations.
Conditions
- Colorectal Cancer
- Colorectal Adenocarcinoma
- Colorectal Cancer Metastatic
- Advanced Colorectal Carcinoma
- Advanced Colorectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VS-6766/avutometinib | An oral anti-cancer medication. |
| DRUG | Cetuximab | A chemotherapy drug used to treat head, neck and colorectal cancer. |
| OTHER | Pill Diary | A diary where participants in phase 2 of study will log their medications and times they are taken on study. |
Timeline
- Start date
- 2022-08-22
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2022-01-20
- Last updated
- 2026-03-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05200442. Inclusion in this directory is not an endorsement.