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Monoclonal Antibodies

VS-6766 + Cetuximab for Colorectal Cancer

Phase 1 & 2
Recruiting
Led By Ardaman S. Shergill, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants should not be receiving any other study agents concurrently with the study drugs.
For participants with a history of chronic hepatitis B virus infection, the hepatitis B virus (HBV) viral load must be undetectable on suppressive therapy, if indicated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the safety of combining a new drug (VS-6766) with an existing drug (cetuximab) to treat colorectal cancer. It's for people whose cancer has progressed despite other treatments, or who can't take/tolerate other treatments. If you participate, you'll be in the trial for up to 2 years.

Who is the study for?
Adults with advanced colorectal cancer that has worsened after standard treatments or those who can't tolerate them. Participants must have specific KRAS mutations, not be pregnant or breastfeeding, agree to use contraception, and have no recent major surgeries or other cancer treatments. They should also not be on conflicting medications and must meet health criteria including organ function tests.Check my eligibility
What is being tested?
The trial is testing the safety of combining VS-6766, a new drug, with cetuximab in patients with advanced colorectal cancer. It aims to see how well these drugs work together for up to 24 months of participation. Patients will keep a pill diary as part of the study.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from compounds like cetuximab (e.g., skin reactions), heart issues such as uncontrolled arrhythmias or cardiac insufficiency if predisposed, high blood pressure management problems, and gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not taking any other experimental drugs.
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My hepatitis B virus load is undetectable with treatment.
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I am 18 years old or older.
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My colorectal cancer has spread, cannot be cured, and has a KRAS mutation.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am fully active or can carry out light work.
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My colorectal cancer has spread and has a KRAS mutation, with no curable treatment options.
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I haven't had treatments targeting specific cancer growth factors.
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I haven't had chemotherapy, radiotherapy, or major surgery in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 Primary Objective: Objective Response Rate of Participants Who Take Phase I /MTD Dose of VS-6766 combined with Cetuximab
Phase I Primary Objective: Maximum Tolerated Dose (MTD) of VS-6766 combined with Cetuximab
Secondary outcome measures
Phase 1 Objective: Frequency/ Type of Dose-Limiting Toxicities (Serious Side Effects) Reported Among Participants Taking VS-6766 and Cetuximab
Phase 1 Objective: The Number of Dose-Limiting Toxicities (Serious Side Effects) Reported Among Participants Taking VS-6766 and Cetuximab
Phase 2 Objective: Duration of Response
+6 more

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Hyponatremia
19%
Acne
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Pruritus
15%
Fatigue
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Cough
9%
Dizziness
9%
White Blood Cell Count Decreased
7%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Hypochloremia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Dyspnoea
6%
Neck pain
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Microcytic anemia
1%
Pulmonary embolism
1%
Respiratory alkalosis
1%
Pneumonia
1%
Electrolyte imbalance
1%
Mouth hemorrhage
1%
Pneumonitis
1%
Myocardial infarction
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 2 (Efficacy Arm/ Expansion Cohort)Experimental Treatment3 Interventions
Participants in this arm will help test the efficacy of the VS-6766 and cetuximab dose established in phase 1 of the study. Participants will take the same two drugs ( VS-6766 and cetuximab) at the best tolerated dose that was found during the first phase of the study. Participants in this group will also keep a pill diary. This helps you keep track of when you take your pills. The study team at your doctor's office will show you how to use this diary. Each time you visit the clinic, you must bring the pill diary, any remaining pills, and the pill bottle.
Group II: Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2Experimental Treatment2 Interventions
Participants in this group will received the second lowest dose of the VS6766 and cetuximab regimen. Inclusion in this group is optional and based on whether the participant reports serious side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: VS-6766 (2.4mg) orally twice a week cetuximab (300mg) via intravenous (IV) needle in vein every 2 weeks
Group III: Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1Experimental Treatment2 Interventions
Participants in this group will received a lower dose of the VS6766 and cetuximab regimen. Inclusion in this group is optional and based on whether the participant reports serious side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: VS-6766 (2.4mg) orally twice a week cetuximab (400mg) via intravenous (IV) needle in vein every 2 weeks
Group IV: Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)Experimental Treatment2 Interventions
This study will use two dose levels (a starting dose at level 1 and a second dose highest dose at level 2) of the VS-6766 and cetuximab regimen. If participants in group 1 don't experience severe negative side effects to the starting dose of the regimen, then more participants will be assigned to group 2 at a higher dose until the safest/ most tolerable dose is found. If participants show toxic side effects to the first pre-determined dose, the dose will be decreased to the next lower dose level. Participants in group 2 will receive the second highest dose of study drugs (below): VS-6766 (3.4mg) orally twice a week cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks During phase 1, VS-6766 and cetuximab will be given in 28-day "cycles" (a period of time when participants receive study drugs). Participants in this portion of the study will receive 12 cycles of VS-6766 and cetuximab.
Group V: Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)Experimental Treatment2 Interventions
This study will use two dose levels (a starting dose at level 1 and a second dose highest dose at level 2) of the VS-6766 and cetuximab regimen. If participants in group 1 don't experience severe negative side effects to the starting dose of the regimen, then more participants will be assigned to group 2 at a higher dose until the safest/ most tolerable dose is found. If participants show toxic side effects to the first pre-determined dose, the dose will be decreased to the next lower dose level. Group 1/ Dose Level 1: Participants in group 0 will receive the starting dose of study drugs (below): VS-6766 (2.4mg) orally twice a week cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks During phase 1, VS-6766 and cetuximab will be given in 28-day "cycles" (a period of time when participants receive study drugs). Participants in this portion of the study will receive 12 cycles of VS-6766 and cetuximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
RAF/MEK inhibitors, such as VS-6766, target the RAF/MEK/ERK signaling pathway, which is often overactive in colorectal cancer cells, leading to uncontrolled growth. By inhibiting this pathway, these drugs can reduce tumor proliferation. Cetuximab, an EGFR inhibitor, binds to the epidermal growth factor receptor on cancer cells, blocking signals that promote cell division and survival. This can slow or stop cancer growth. These targeted therapies are important for colorectal cancer patients as they offer more precise treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,017 Previous Clinical Trials
734,466 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
39 Previous Clinical Trials
2,565 Total Patients Enrolled
Ardaman S. Shergill, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05200442 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose), Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose), Phase 2 (Efficacy Arm/ Expansion Cohort), Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2, Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05200442 — Phase 1 & 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05200442 — Phase 1 & 2
~20 spots leftby Aug 2025