CEND-1 + FOLFIRINOX for Digestive Cancer
(CENDIFOX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment combination for certain digestive cancers, such as pancreatic, colon, and appendix cancer. The study examines how well the drug CEND-1 works with Folfirinox (a chemotherapy regimen), and sometimes with Panitumumab, to address these challenging cancers. Suitable candidates for this trial include those with specific types of these cancers that are potentially removable through surgery and have not received other cancer treatments in the last two years. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use any other anti-cancer therapy while participating. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that combining CEND-1 with FOLFIRINOX is generally well-tolerated by patients with certain types of cancer. Studies found that adding CEND-1 to FOLFIRINOX is safe for patients with a type of pancreatic cancer. These early results showed that patients could handle the treatment without major problems.
Similarly, research indicates that combining FOLFIRINOX with Panitumumab is also generally safe. This combination has been used in patients with colorectal cancer who have specific gene types (RAS/BRAF wild type) and did not cause unexpected side effects.
In summary, both treatment combinations have been tested and are considered safe based on current data. Participants who met the study criteria managed the treatments without severe side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CEND-1 combined with FOLFIRINOX because it offers a novel approach to treating digestive cancers, particularly pancreatic and colon cancers. Unlike the current standard of care, which often involves chemotherapy alone, this combination introduces CEND-1, a peptide that enhances the uptake of chemotherapy drugs by targeting the tumor's microenvironment. This unique mechanism aims to improve the effectiveness of FOLFIRINOX, potentially leading to better outcomes for patients. Additionally, when paired with Panitumumab in certain cases, this treatment could offer a more personalized approach, especially for patients with specific genetic profiles like RAS/BRAF mutations.
What evidence suggests that this trial's treatments could be effective for digestive cancer?
Research has shown that combining CEND-1 with FOLFIRINOX may hold promise for treating certain digestive cancers. In this trial, participants in Cohort 1 will receive FOLFIRINOX, followed by FOLFIRINOX plus CEND-1, for pancreatic cancer. Studies have found this combination to be safe for patients with pancreatic cancer, with many experiencing ongoing benefits. Earlier trials reported a 26% success rate for FOLFIRINOX alone in treating advanced pancreatic cancer, with some patients achieving complete recovery.
For participants in Cohorts 2 and 3, the combination of FOLFIRINOX and Panitumumab, with or without CEND-1, is being tested for peritoneal metastases and oligometastatic colon cancer. Research has shown high success rates for FOLFIRINOX and Panitumumab, though it did not achieve all primary goals in some colorectal cancer cases. However, it was effective enough in some patients to shrink tumors for surgical removal. These findings suggest that these combinations could be effective against digestive cancers, but further research is needed to fully understand their potential.12356Who Is on the Research Team?
Anup Kasi, MD
Principal Investigator
University of Kansas Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with certain types of cancer (pancreatic, colon, or appendiceal) who are in good physical condition and have not had other cancer treatments in the past 2 years. They must be able to understand the study and agree to its terms. Pregnant women and those with serious heart conditions or infections are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Folfirinox with or without Panitumumab and CEND-1 for 3 cycles, followed by surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and disease-free survival
What Are the Treatments Tested in This Trial?
Interventions
- CEND-1
- Folfirinox
- Panitumumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anup Kasi
Lead Sponsor
Cend Therapeutics Inc.
Collaborator