AzTrials
AzTrials

Colon CancerPhase 1/2CENDIFOXNCT05121038

CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab

A Phase 1/2 study testing CEND-1, Panitumumab and Folfirinox in people with Colon Cancer and Pancreas Cancer, run by Anup Kasi at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer, Pancreas Cancer, Digestive Cancer
What is being tested?
CEND-1, Panitumumab and Folfirinox
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
20 Oct 2021to Sep 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
  • One or more lesions evaluable on MRI, positive emission tomography (PET)/CT, or dedicated CT scan according to RECIST v1.1
  • Patients with histologically confirmed pancreatic ductal adenocarcinomas, colorectal and appendiceal adenocarcinomas
  • For cohort 1: Resectable Pancreatic Cancer: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be clear fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture. Please refer to 2021 NCCN PDAC Guidelines
  • For cohort 1: Borderline Resectable Pancreatic Cancer: defined as localized cancer with 1 or more of the following features: "a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall. Please refer to 2021 National Comprehensive Cancer Network (NCCN) Pancreatic Ductal Adenocarcinoma (PDAC) Guidelines
Show all 14Show fewer
  • For cohort 2: Peritoneal Metastases due to Colorectal Cancer or Invasive Adenocarcinoma of the Appendix
  • For cohort 3: Oligometastatic colorectal cancer: resectable metastases as determined by multidisciplinary evaluation. Patients with bilobar liver metastases or oligometastatic liver and lung metastases that requires resection of one or more metastases are also allowed
  • Eligible for treatment with FOLFIRINOX with or without panitumumab
  • Life expectancy of at least 3 months
  • Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts and on treatment
  • Medically fit to undergo complex major abdominal surgery at end of study treatment
  • Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to enrollment
  • Adequate organ function

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents
  • Prior chemotherapy or any other investigational agents for the treatment of cancer within 2 years prior to enrollment on this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant or breastfeeding
  • Has a known allergic reaction to any excipient contained in the study drug formulation
Show all 14Show fewer
  • Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
  • Participants with known brain metastases. Screening for brain metastases with head imaging is not required
  • History of prior or current synchronous malignancy, except:
  • Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment
  • Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, without evidence of prostate cancer

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The University of Kansas Cancer Center (KUCC)

    Fairway, Kansas, 66205

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas, 66205

  • The University of Kansas Medical Center

    North Kansas City, Missouri, 64116

Other trials in United States

About this study

Official title: A Phase 1B/2A Trial of CEND-1 in Combination with Neoadjuvant FOLFIRINOX Based Therapies in Pancreatic, Colon and Appendiceal Cancers (CENDIFOX)

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

Being tested
CEND-1, Panitumumab, Folfirinox
Medical subject headings
Colonic Neoplasms, Pancreatic Neoplasms, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEND-1Drug

    Also called LSTA1, Certepetide

    The treatment with CEND-1 will be given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle starting in Cycle 4).

  • PanitumumabDrug

    Up to ten (10) participants with cancer that has spread to certain areas of the body and who have a certain gene in the tumor called "RAS/BRAF wild type" will receive another drug called panitumumab in addition to CEND-1 and FOLFIRINOX.

  • FolfirinoxDrug

    Also called Oxaliplatin,Leucovorin,Irinotecan,Fluorouracil

    FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order.

    All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle).

    • Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then
    • Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours.
    • Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours. then
    • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.
Study groups in NCT05121038
Study groupRoleWhat they receive
Cohort 1 Pancreatic CancerExperimentalBiopsy 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.
Receives: Drug: CEND-1; Drug: Folfirinox
Cohort 2 Peritoneal MetsExperimentalBiopsy 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.
Receives: Drug: CEND-1; Drug: Panitumumab; Drug: Folfirinox
Cohort 3 Oligomets Colon CancerExperimentalBiopsy 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.
Receives: Drug: CEND-1; Drug: Panitumumab; Drug: Folfirinox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Adverse Events : Counts and proportions of grade 3 -5 Adverse Events

    Measured: 24 months

Secondary outcomes (5)

  1. Overall survival (OS)

    Overall survival (OS) will be reported using median survival time along with a 90% confidence interval

    Measured: 48 months

  2. Disease-free survival (DFS)

    Disease-free survival (DFS) will be reported using median survival time along with a 90% confidence interval

    Measured: 48 months

  3. Overall response rate (ORR)

    Overall response rate (ORR) will be reported as a proportion with 90% confidence interval.

    Measured: 24 months

  4. RO resection rate (RORR)

    RO resection rate (RORR) will be reported as a proportion with 90% confidence interval.

    Measured: 24 months

  5. Pathological response rate (PCR) .

    Pathological response rate (PCR) will be reported as a proportion with 90% confidence interval.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start20 Oct 2021
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121038
Sponsor's protocol ID
IIT-2021-CENDIFOX
Acronym
CENDIFOX
Status last verified
Aug 2024
First submitted
19 Oct 2021
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CEND-1, Panitumumab and Folfirinox in people with Colon Cancer and Pancreas Cancer, run by Anup Kasi at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05121038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in