30 Participants NeededMy employer runs this trial

GLP-1 RA for Colorectal Cancer

RE
PZ
Overseen ByPrisca Zimmerman
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Arizona
Must be taking: GLP-1 receptor agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether semaglutide, a GLP-1 Receptor Agonist, can be safely combined with standard chemotherapy to treat certain advanced cancers, such as metastatic colorectal cancer. Researchers seek to discover if adding semaglutide enhances the effectiveness of standard cancer treatments while maintaining patient safety. The trial targets individuals with specific types of advanced cancers who have a body mass index (BMI) over 25 and are undergoing their first set of cancer treatments. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking cancer treatment development.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that patients on insulin are excluded, and those with HBV must be on antiviral therapy. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, a type of medication, is generally safe for use. Large studies involving over 60,000 participants found no increased risk of colorectal cancer compared to a placebo. In fact, these medications may lower the risk of developing colorectal cancer. Some studies report a significant decrease in colon cancer risk with these drugs. Additionally, the FDA has not identified any safety concerns related to colorectal cancer with this type of medication. Overall, these findings suggest semaglutide is well-tolerated, but this trial is needed to confirm its safety when used with chemotherapy for certain cancers.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using Semaglutide, a GLP-1 receptor agonist, for treating colorectal cancer because it offers a unique approach compared to the standard treatments like FOLFOX or FOLFIRI. Unlike traditional chemotherapy, which directly targets cancer cells, Semaglutide works by mimicking a hormone that regulates insulin, potentially influencing cancer growth indirectly by affecting metabolism and weight. This novel mechanism provides a fresh angle in tackling cancer, particularly for patients with a higher BMI, and could complement existing therapies to improve outcomes.

What evidence suggests that this trial's treatments could be effective for metastatic colorectal cancer?

Research has shown that medications like semaglutide, known as GLP-1 receptor agonists, may help reduce the risk and slow the progression of certain cancers, such as colorectal, pancreatic, and liver cancer. In this trial, participants with metastatic colorectal adenocarcinoma will receive semaglutide alongside standard-of-care (SOC) treatment, which may include FOLFOX or FOLFIRI with or without bevacizumab. For pancreatic cancer, participants will receive semaglutide with SOC treatment, specifically modified FOLFIRINOX. In liver cancer, semaglutide will be administered with SOC treatment, specifically Tremelimumab/Durvalumab. This evidence suggests that semaglutide might effectively manage these cancers along with standard treatments.25678

Who Is on the Research Team?

AJ

Aaron J Scott, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, metastatic pancreatic, colorectal, or liver cancer who have not yet received treatment for their advanced disease. Participants must be able to safely receive both chemotherapy and the study drug.

Inclusion Criteria

I have tumors that can be measured on scans.
I have been diagnosed with liver cancer based on imaging or biopsy.
My liver function is classified as Child-Pugh A or B7/B8.
See 14 more

Exclusion Criteria

Known sensitivity to study products or components
HCC Cohort ONLY: History of allogenic organ transplantation
BMI < 25 kg/m2
See 33 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 RA weekly in combination with standard of care chemotherapy for up to 6 months or until disease progression

Up to 6 months
Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Periodic visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study is testing whether adding a medication called semaglutide (a GLP-1 receptor agonist) to standard first-line chemotherapy is safe and effective in people with advanced gastrointestinal cancers.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Metastatic Pancreatic Adenocarcinoma (PDAC)Experimental Treatment1 Intervention
Group II: Metastatic Hepatocellular Carcinoma (HCC)Experimental Treatment1 Intervention
Group III: Metastatic Colorectal Adenocarcinoma (CRC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

Citations

GLP-1 receptor agonists and cancer: current clinical evidence ...

In a meta-analysis of five studies that included over 2 million people, colorectal cancer risk was significantly lower in people using GLP-1R ...

Emerging Evidence Positions GLP-1 Receptor Agonists as ...

GLP-1 RA use has also been associated with 62% lower odds of 5-year mortality in patients with established colon cancer (OR, 0.38; 95% CI, 0.21- ...

Real-world analysis on the impact of GLP-1 receptor ...

Conclusions: GLP-1RA therapy was associated with reduced all-cause mortality in patients with CRC, without an observed increase in metastatic ...

Glucagon-like Peptide-1 Receptor Agonists and Colorectal ...

Using 1:1 propensity matching, the study found GLP-1RA therapy was associated with a significantly reduced risk of CRC in patients with T2DM relative to insulin ...

Real-World Data Favor GLP-1 vs Aspirin in Colorectal ...

At a median 6-year follow-up for GLP-1RA users and 5 years for aspirin users, the use of a GLP-1RA reduced the risk of CRC by 35.7% compared ...

Association between GLP-1 receptor agonists as a class and ...

Overall, this study suggests a significantly increased risk of colorectal cancer associated with GLP-1 RA use in patients receiving GLP-1 RAs.

GLP-1 RAs Linked to Reduced Colon Cancer Risk

In analyses of specific drugs, a significantly lower risk for colon cancer was observed with use of albiglutide (RR, 0.33; 95% CI, 0.12-0.97) ...

GLP-1 receptor agonist vs aspirin for primary prevention of ...

Conclusions: In this real-world comparison, GLP-1RAs were associated with a 26% relative reduction in CRC incidence compared to aspirin. These ...