A Phase I/IIa Study of EF-009 in Patients with Pancreatic Cancer

NCT04381130 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EFBPOLZ20190701
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  Phase I

  21 days

• Overall survival

  Phase IIa

  2 years

Secondary Outcomes (8)

• Progression Free Survival

  2 years

• Proportion of subjects underwent pancreatic resection surgery after the EF-009 wafer implantation

  2 years

• Time to pancreatic resection surgery after the EF-009 wafer implantation

  2 years

• Objective response rate

  2 years

• Best response rate

  2 years

Study Arms (1)

EF-009

EXPERIMENTAL

In both the Phase I and Phase IIa portions of the study, subjects will be evaluated for response every 8 weeks after EF-009 wafer implantation for up to 2 years, by CT, PET/CT or MRI (per treating investigator's discretion) using the same method as at baseline. Tumor measurements will be assessed based on the Response Evaluation Criteria in Solid Tumors guidelines version 1.1 (RECIST v1.1). The total study duration for each subject consists of screening, treatment, and extended follow-up period and survival follow-up period.

Drug: EF-009

Interventions

EF-009 DRUG

Subjects who meet the eligibility criteria will have completed following evaluations and assessments before receiving treatment: a) review of medical and medication history; b) physical examination, vital signs and documentation of ECOG; c) ECG; d) routine serum biochemical, hematologic, urine pregnancy (if applicable) and urine laboratory assessments; and e) evaluation of European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 score. On Day 0, subjects will undergo EF-009 wafer implantation via laparoscopy

EF-009

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Borderline resectable or unresectable pancreatic cancer judged by the PI in consultation with the designated site radiologist and surgeon at the treating institution Borderline resectable tumors are those that have:
• no distant metastases;
• venous involvement of the superior mesenteric vein (SMV)/portal vein (PV) with or without impingement and narrowing of the lumen;
• short segment venous occlusion but with suitable vessel proximal and distal to occlusion, allowing for safe resection and reconstruction;
• gastroduodenal artery (GDA) encasement up to the hepatic artery (HA) with either short segment encasement or direct abutment of HA, without extension to the celiac axis (CA); and
• tumor abutment of the SMA not to exceed 180° of the circumference.
• Unresectable tumors are those that have:
• Arterial:
• Head/uncinate process:
• Solid tumor contact with SMA \>180°
• Solid tumor contact with the CA \>180°
• Body and tail:
• Solid tumor contact of \>180° with the SMA or CA

You may not qualify if:

• 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
• Patient has other severe and/or life-threatening disease(s) with life expectancy less than 12 months
• Subjects who have an immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive.
• Subjects with medical, social or psychological factors interfering with compliance of the study
• Subjects that have on-going moderate to severe organ impairment, other than the study indication, that may confound the efficacy evaluation, safety evaluation or usage of standard chemotherapy
• Female subjects that are lactating, pregnant, or planned to become pregnant

Sponsors & Collaborators

• Everfront Biotech Co., Ltd.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

David Liu, PhD

CONTACT

+88638630108; coldwee@efbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02