Your session is about to expire
← Back to Search
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 belowSelect...
I am not taking any other experimental drugs.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I am 18 years old or older.
Select...
My colorectal cancer has spread, cannot be cured, and has a KRAS mutation.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I am fully active or can carry out light work.
Select...
My colorectal cancer has spread and has a KRAS mutation, with no curable treatment options.
Select...
I haven't had treatments targeting specific cancer growth factors.
Select...
I haven't had chemotherapy, radiotherapy, or major surgery in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreSide effects data
From 2012 Phase 3 trial • 73 Patients • NCT0117795643%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
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%
Pulmonary embolism
1%
Respiratory alkalosis
1%
Microcytic anemia
1%
Myocardial infarction
1%
Pneumonia
1%
Pneumonitis
1%
Electrolyte imbalance
1%
Mouth hemorrhage
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
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
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,677 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,545 Total Patients Enrolled
Ardaman S. Shergill, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a detectable tumor that can be measured using specific medical criteria.I am not taking any other experimental drugs.I don't have specific eye conditions like retinal detachment or macular degeneration.You have had allergic reactions to drugs or biological substances similar to cetuximab, or have a history of red meat allergy or tick bites.I am 18 years old or older.I do not have any severe illnesses that are not under control.You have had allergic reactions to medications similar to cetuximab or have had an allergy to red meat or a tick bite.My colorectal cancer has spread, cannot be cured, and has a KRAS mutation.I am not on strong CYP3A4 inducers, or can stop them 14 days before the study starts.I do not have eye conditions that could lead to retinal vein occlusion.My hepatitis B virus load is undetectable with treatment.My heart is healthy according to my doctor.I don't have untreated brain metastases and if treated, they've been stable for at least a month.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am fully active or can carry out light work.I have not had COVID-19 in the last 28 days and I have Gilbert's syndrome.I have a skin condition that needed treatment throughout my body in the last year.I haven't had any bowel perforation or intestinal fistulas in the past 6 months.My colorectal cancer has spread and has a KRAS mutation, with no curable treatment options.My cancer progressed after treatment with specific drugs or I have a valid reason for not taking them.My cancer has specific KRAS mutations approved by Dr. Shergill.I am not pregnant or nursing and agree to use effective birth control during and after the study.I haven't had treatments targeting specific cancer growth factors.I am not on any medications that would interfere with the study drugs.I do not have serious heart issues or very high blood pressure.I have had cancer before, but it won't interfere with this study.I have a muscle disorder that increases my CPK levels.I am allergic to VS-6766 or its ingredients like mannitol.I do not have serious eye diseases that could risk my vision during the trial.I do not have glaucoma, retinal vein occlusion, uncontrolled high blood pressure, or uncontrolled diabetes.I do not have active gastrointestinal issues like ulcers or uncontrolled vomiting.I do not have severe nerve damage.I will not consume grapefruit, St. John's Wort, or certain medications and supplements while on VS-6766.I haven't had chemotherapy, radiotherapy, or major surgery in the last 2 weeks.I have had rhabdomyolysis in the last 3 months.I do not have a history of retinal degenerative disease.I am HIV positive, on treatment, and my viral load is undetectable.I have a history of heart rhythm issues related to QT interval.I had skin cancer or cervical cancer treated to cure, or any cancer in remission for 2+ years.I do not have a history of serious eye surface conditions.I am not taking strong CYP3A4 inhibitors, or can stop them for 14 days before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)
- Group 2: Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)
- Group 3: Phase 2 (Efficacy Arm/ Expansion Cohort)
- Group 4: Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2
- Group 5: Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov indicates that recruitment for this trial is currently active, commencing from August 22nd 2022 and last updated September 30th 2022. There are 53 spots open at one research centre."
Answered by AI
Has this clinical study opened its enrollment period yet?
"The trial, which was first listed on August 22nd 2022, is still actively searching for participants. The study details were last edited on September 30th 2022."
Answered by AI
What are the primary goals of this clinical experiment?
"This two-year clinical trial seeks to measure the Maximum Tolerated Dose (MTD) of VS-6766 combined with Cetuximab. Secondary objectives include determining the frequency/type of dose-limiting toxicities reported among participants, assessing duration of response and stable disease as determined by medical records and statistical analysis respectively."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger