← Back to Search

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 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 4 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (Dose expansion)
Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation)
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall response rate
+2 more

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
~1940
Utomilumab
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,174 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,447 Total Patients Enrolled
David S HongPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03290937 — Phase 1
Colorectal Cancer Research Study Groups: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03290937 — Phase 1
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03290937 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How has Pharmacodynamic Study been applied to improve medical treatments?

"Pharmacodynamic Study provides a potential solution for malignant pancreas neoplasms, metastatic cancer and radiation therapy."

Answered by AI

Is the Pharmacodynamic Study compliant with FDA regulations?

"Due to the limited evidence surrounding efficacy and safety, a score of 1 was assigned by our team at Power in regards to pharmacodynamic study."

Answered by AI

Are there currently any openings in this clinical experiment?

"Unfortunately, this specific trial is not currently taking in any new patients. Initially posted on December 27th 2017 and last updated August 4th 2022, it has temporarily closed its recruitment window. Currently, 858 trials are open for colorectal carcinoma while 361 studies related to pharmacodynamics remain active and looking for participants."

Answered by AI

Has research been conducted on the pharmacodynamic profile of this drug?

"At the moment, 361 Pharmacodynamic Study trials are in progress. Of these, 75 have reached Phase 3 status. Even though a majority of these trials originate from Pittsburgh, Pennsylvania, there are 12308 sites worldwide conducting clinical research for this medication."

Answered by AI

What is the upper limit for participants in this experiment?

"At present, no new participants are being sought for this study which was initially advertised on December 27th 2017 and last updated on August 4th 2022. However, there are 858 clinical trials actively recruiting patients with colorectal carcinoma as well as 361 studies in search of volunteers to participate in a Pharmacodynamic Study."

Answered by AI
~6 spots leftby Apr 2025