A Phase I/IIa Study of EF-009 in Patients with Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEverfront Biotech Co., Ltd.
About this trial
This study is a multi center, open-label, dose escalation, Phase I/IIa study of EF-009 in up to 30 patients with borderline resectable and unresectable pancreatic cancer.
Eligibility criteria
Qualifiers
Female or male, age ≥ 18 years old
Subject has cytological, histological, or pathological confirmation of pancreatic cancer Note: All histologic subtype(s) of exocrine and endocrine pancreatic cancer are eligible to enroll in the study
no distant metastases;
venous involvement of the superior mesenteric vein (SMV)/portal vein (PV) with or without impingement and narrowing of the lumen;
Disqualifiers
Subjects who have participated in other investigational studies within 4 weeks prior to receive EF-009
Subjects with known or suspected hypersensitivity to EF-009 or the excipient
Subject not eligible for resection without significantly affecting vital function
Subjects with distant metastasis or recurrence of pancreatic cancer
Trial design
Treatments tested in this trial
- EF-009
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov