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A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05200442•University of Chicago

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must be able to show documentation of disease: Participants must have metastatic colorectal adenocarcinoma with kirsten rat sarcoma viral oncogene homolog (KRAS) mutations, detected by any Clinical Laboratory Improvement Amendments-certified method (tumor or ct-DNA), for which curable treatment modalities are not an option.
•Participants with the following KRAS mutations can be included in the study. These eligible KRAS mutations will be confirmed by the Study Chair, Dr. Shergill. Please contact Dr. Shergill for all other mutations that you feel may benefit from this treatment.
•Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
•Must have had progression of disease on 5-FU or capecitabine, oxaliplatin, irinotecan and bevacizumab therapy or any other approved anti-VEGF therapy or must have a scientifically justifiable reason for not having had these therapies prior to trial. If participant has high levels of MicroSatellite Instability (MSI-H), they must have had recommended immunotherapy agent(s) i.e anti- programmed death ligand 1 (L)1 with or without anti-CTLA4 agents.
•No prior Lonsurf or regorafenib treatment is allowed.
•Must have not had any treatment with prior MEK (mitogen-activated protein kinase kinase) inhibitor, anti-EGFR (antineoplastic epidermal growth factor receptor), KRAS, SOS1 ( Son of sevenless 1) and SHP2 (Src homology-2 domain-containing protein tyrosine phosphatase-2) inhibitor therapy.
•Participants should not have had chemotherapy, radiotherapy, or major surgery within 2 weeks prior to entering the study.
•Participants should not be receiving any other study agents concurrently with the study drugs.
•Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required. Negative serum pregnancy test is required for all female patients of child bearing potential within 7 days of cycle 1 day. All patients should agree to use highly effective method of contraceptive: female patient up to 2 months after 30 days of the last dose and male pts up to 90 days of the last dose.
•Must be 18 years old or older.
+6 more criteria

Exclusion Criteria

•Participants with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements, hypertension, defined as systolic blood pressure \> 160 mmHg despite medical management, myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting \< 12 months prior to screening.
•Participants with clinically relevant coronary artery disease or history of myocardial infarction in last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency, or those with uncontrolled or poorly controlled hypertension (\>180 millimeters of mercury (mmHg) systolic or \>130 mmHG diastolic pressures) may not receive cetuximab.
•Participants with history of corrected QT interval (QTc) prolongation, Brugada syndrome, known history of QTc prolongation, or Torsades de Pointes.
•Participants with known COVID-19 infection within 28 days prior to first dose of therapy are excluded. History of Gilbert's syndrome.
•Participants with history of recent rhabdomyolysis within last 3 months.
•Participants with active skin disorder that has requested systemic therapy within past 12 months.
•Participants with a history of neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
•History of other malignancy which could affect compliance with the protocol or interpretation of results.
•History of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed. Subjects with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for ≥ 2 years prior to Cycle 1, Day 1. Subjects with localized prostate cancer that has been treated with curative intent will be allowed.
•Participants planning to embark on a new strenuous exercise regimen after the first dose of study treatment (e.g. running or bicycling \> 10 mph) due to risk of CPK elevation.
+18 more criteria

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

August 22, 2022

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

November 5, 2025

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerColorectal AdenocarcinomaColorectal Cancer MetastaticAdvanced Colorectal CarcinomaAdvanced Colorectal Adenocarcinoma

Interventions

VS-6766/avutometinib

DRUG

Cetuximab

DRUG

Pill Diary

OTHER

Contacts

Ardaman S. Shergill, MD

CONTACT

773-702-8114 ashergill@medicine.bsd.uchicago.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease