CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab (NCT05121038) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab
United States50 participantsStarted 2021-10-20
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 recā¦
What they're measuring
1
Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0