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Monoclonal Antibodies
Utomilumab + Cetuximab + Irinotecan for Colorectal Cancer
Phase 1
Waitlist Available
Led By David S Hong
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the best dose and side effects of irinotecan hydrochloride given with utomilumab and cetuximab to treat patients with metastatic colorectal cancer.
Who is the study for?
This trial is for adults with metastatic colorectal cancer who've had at least one line of chemotherapy. They must have known RAS tumor status, be willing to use two contraception methods if applicable, and not be pregnant or breastfeeding. Exclusions include brain metastases requiring steroids, recent major surgery or radiation therapy, autoimmune disorders affecting the immune system, serious infections like hepatitis B/C or HIV/AIDS, unstable medical conditions in the past 6 months.
What is being tested?
The trial tests how well patients respond to a combination of utomilumab and cetuximab with irinotecan hydrochloride chemotherapy. It aims to find the best dose while assessing side effects. Utomilumab and cetuximab are monoclonal antibodies that may prevent cancer growth; irinotecan hydrochloride is a chemo drug that kills or stops cancer cells from dividing.
What are the potential side effects?
Possible side effects include reactions related to the immune system due to monoclonal antibodies (like inflammation), typical chemo side effects such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems. Each patient's experience can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (Dose expansion)
Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation)
Secondary study objectives
Incidence of adverse events
Overall survival
Progression free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)Experimental Treatment4 Interventions
Patients receive irinotecan hydrochloride IV over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Utomilumab
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,202 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,973 Total Patients Enrolled
David S HongPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
273 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain autoimmune disorders or conditions that weaken your immune system, except if you have mild psoriasis that is under control or mild autoimmune thyroiditis that is managed with medication.You have another type of cancer that is currently growing, except for non-melanoma skin cancer or early-stage cervical cancer.If you have a specific type of colorectal cancer with high microsatellite instability, you need to have already received a certain type of medication before joining this trial.You have experienced a severe allergic reaction to antibodies or infused proteins in the past, or you have had a severe allergic reaction to any of the substances in the study drug.You have been diagnosed with ovarian failure by a doctor.You have a serious medical or mental health condition, or a recent history of suicidal thoughts or behavior that could affect your safety or the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
Awards:
This trial has 1 awards, including:- 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.
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