50 Participants Needed

CEND-1 + FOLFIRINOX for Digestive Cancer

(CENDIFOX Trial)

Recruiting at 2 trial locations
KN
Overseen ByKUCC Navigation
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Anup Kasi
Must be taking: Folfirinox, Panitumumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment CEND-1 + FOLFIRINOX for digestive cancer?

Research shows that FOLFIRINOX, a part of the treatment, has been effective in improving survival and quality of life in patients with pancreatic cancer compared to other treatments. It has shown better progression-free survival and overall survival in patients with borderline resectable pancreatic cancer compared to a gemcitabine-based regimen.12345

Is the combination of CEND-1 and FOLFIRINOX safe for humans?

FOLFIRINOX, a part of the treatment combination, is known to cause significant side effects, including blood-related issues like febrile neutropenia (a condition with fever and low white blood cells) and other toxic effects, which often require dose adjustments or stopping the treatment.26789

What makes the CEND-1 + FOLFIRINOX treatment unique for digestive cancer?

The CEND-1 + FOLFIRINOX treatment is unique because it combines CEND-1, a novel agent, with FOLFIRINOX, a chemotherapy regimen known for its effectiveness in pancreatic cancer. This combination aims to enhance the delivery and effectiveness of chemotherapy, potentially offering a new approach for treating digestive cancers.12358

What is the purpose of this trial?

This is a phase IB/IIA trial to ensure the safety of Certepetide (LSTA1/CEND-1) in combination with with Folfirinox with or without Panitumumab for treatment of pancreatic, colon and appendiceal cancers

Research Team

Dr. Anup K Kasi Loknath Kumar, MD, MPH ...

Anup Kasi, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

I have taken a pregnancy test in the last 3 days and it was negative.
My pancreatic cancer can be surgically removed and hasn't spread far.
You are expected to live for at least 3 more months.
See 11 more

Exclusion Criteria

Is pregnant or breastfeeding
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
I haven't had a severe infection in the last 2 weeks.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Folfirinox with or without Panitumumab and CEND-1 for 3 cycles, followed by surgery

Approximately 9 weeks
Multiple visits for infusions and biopsies

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term follow-up

Participants are monitored for overall survival and disease-free survival

48 months

Treatment Details

Interventions

  • CEND-1
  • Folfirinox
  • Panitumumab
Trial Overview The safety of a new drug combination is being tested: CEND-1 with FOLFIRINOX chemotherapy, with some patients also receiving Panitumumab. The goal is to see how well these drugs work together against specific cancers before surgery.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cohort 3 Oligomets Colon CancerExperimental Treatment3 Interventions
Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.
Group II: Cohort 2 Peritoneal MetsExperimental Treatment3 Interventions
Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.
Group III: Cohort 1 Pancreatic CancerExperimental Treatment2 Interventions
Biopsy for tissue immune profile if archived tissue not available. Folfirinox infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anup Kasi

Lead Sponsor

Trials
1
Recruited
50+

Cend Therapeutics Inc.

Collaborator

Trials
2
Recruited
100+

Findings from Research

FOLFIRINOX (FFX) has been shown to significantly improve median overall survival, progression-free survival, and objective response rates in patients with metastatic pancreatic cancer compared to gemcitabine, as established in the PRODIGE 4/ACCORD 11 study.
Despite initial concerns about its toxicity, FFX has been widely adopted in clinical practice, leading to new research opportunities and discussions about managing its side effects and optimizing treatment protocols.
Pancreatic cancer and FOLFIRINOX: a new era and new questions.Marsh, Rde W., Talamonti, MS., Katz, MH., et al.[2023]
In a study of 289 patients with advanced pancreatic ductal adenocarcinoma, the FOLFOXIRI chemotherapy regimen showed similar overall survival (11.1 months) compared to the standard FOLFIRINOX regimen (11.6 months), indicating no significant therapeutic advantage for FOLFOXIRI.
FOLFOXIRI was associated with a higher incidence of grade 3/4 digestive adverse events (28.7% vs. 19.5% for FOLFIRINOX), suggesting that while it is feasible, it may lead to more severe side effects without improving survival outcomes.
FOLFOXIRI vs FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: A population-based cohort study.Vienot, A., Chevalier, H., Bolognini, C., et al.[2020]
Neoadjuvant FOLFIRINOX treatment in patients with borderline resectable pancreatic cancer (BRPC) resulted in a median overall survival of 22.2 months and a high resection rate of 67.8%, indicating its potential effectiveness in this patient group.
The treatment was associated with manageable adverse events, with the most common being neutropenia, diarrhea, and fatigue, but no deaths were reported due to FOLFIRINOX, suggesting a favorable safety profile.
Neoadjuvant FOLFIRINOX in Patients With Borderline Resectable Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis.Janssen, QP., Buettner, S., Suker, M., et al.[2021]

References

Pancreatic cancer and FOLFIRINOX: a new era and new questions. [2023]
Population pharmacokinetics of FOLFIRINOX: a review of studies and parameters. [2019]
FOLFOXIRI vs FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: A population-based cohort study. [2020]
Efficacy and safety of neoadjuvant FOLFIRINOX for borderline resectable pancreatic adenocarcinoma: improved efficacy compared with gemcitabine-based regimen. [2018]
Neoadjuvant FOLFIRINOX in Patients With Borderline Resectable Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis. [2021]
FOLFIRINOX relative dose intensity and disease control in advanced pancreatic adenocarcinoma. [2022]
A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer. [2022]
Chemoradiation after FOLFIRINOX for borderline resectable or locally advanced pancreatic cancer. [2022]
A post-marketing safety study of ramucirumab with FOLFIRI in patients with metastatic colorectal cancer. [2022]
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