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Clinical Trial Record

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

2025-09-01

2025-12-01

2026-12-01

30

Study Overview

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

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.

In Phase I, the study will follow a ȣ+3" design to determine the maximum tolerated dose (MTD) of EF-009 implanted surgically in patients with pancreatic cancer. The MTD is defined as one dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in ≥ 33% of the participants. Phase IIa is a single arm study with up to 12 subjects in order to test the hypothesis that the MTD of EF-009 will increase the overall survival (OS) and progression free survival (PFS) in patients with borderline resectable and unresectable pancreatic cancer. The number of EF-009 implanted will be based on the MTD dose determined in the Phase I portion of the study. 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.

  • Pancreatic Cancer
  • DRUG: EF-009
  • EFBPOLZ20190701

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-05-07  

N/A  

2025-02-24  

2020-05-07  

N/A  

2025-02-26  

2020-05-08  

N/A  

2025-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: EF-009

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 a

DRUG: EF-009

  • 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) routin
Primary Outcome MeasuresMeasure DescriptionTime Frame
Maximum Tolerated Dose (MTD)Phase I21 days
Overall survivalPhase IIa2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression Free Survival2 years
Proportion of subjects underwent pancreatic resection surgery after the EF-009 wafer implantation2 years
Time to pancreatic resection surgery after the EF-009 wafer implantation2 years
Objective response rate2 years
Best response rate2 years
Time to objective tumor response2 years
Tumor response duration2 years
Change in quality of life assessed with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.02 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: David Liu, PhD

Phone Number: +88638630108

Email: coldwee@efbiotech.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Female or male, age ≥ 18 years old 2. 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 3. 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:
    1. no distant metastases; 2. venous involvement of the superior mesenteric vein (SMV)/portal vein (PV) with or without impingement and narrowing of the lumen; 3. short segment venous occlusion but with suitable vessel proximal and distal to occlusion, allowing for safe resection and reconstruction; 4. 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 5. tumor abutment of the SMA not to exceed 180° of the circumference.
    Unresectable tumors are those that have: 1. 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
  • Solid tumor contact with the CA and aortic involvement 2. Venous

    • Head/uncinate process:
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be due to tumor or bland thrombus)
  • Contact with most proximal draining jejunal branch into SMV

    • Body and tail:
    • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be due to tumor or bland thrombus) 4. Subjects have an ECOG performance status ≤ 1 5. Subjects who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms 6. Patients are recovered from toxicities from prior systemic therapies to CTCAE grade 0 or 1 (alopecia ≤ Grade 2 can enroll) and have adequate hematopoietic, liver and renal function at screening and before using study medication

  • Haemoglobin ≥ 8 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Absolute lymphocyte count ≥ 1000/mm3,
  • Platelets ≥ 100,000 /mm3
  • Total white blood cell (WBC) ≥ 3,000 cells /mm3
  • Coagulation tests (prothrombin time [PT], activated partial thromboplastin time [APTT], International Normalized Ratio [INR]) < 1.5×ULN,
  • Total bilirubin ≤ 1.5×ULN,
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase(SGOT) or Alanineaminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN
  • Estimated Glomerular Filtration Rate (GFR) ≥ 60 mL/min (MDRD method)

    • Glomerular Filtration Rate (GFR) is calculated using the MDRD formula:
    GFR = 175 x (Standardized SCr)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African American) 7. The subject agrees not to use food supplementary or dietary that contains Angelica sinensis after Screening Visit to Day 21. 8. All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after EF-009 treatment shown below.

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
  • Combination of any two of the following (a+b or a+c, or b+c):

    • 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 3. Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    Exclusion Criteria:
    1. Subjects who have participated in other investigational studies within 4 weeks prior to receive EF-009 2. Subjects with known or suspected hypersensitivity to EF-009 or the excipient 3. Subject not eligible for resection without significantly affecting vital function 4. Subjects with distant metastasis or recurrence of pancreatic cancer 5. Patient has other severe and/or life-threatening disease(s) with life expectancy less than 12 months 6. Subjects who have an immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive. 7. Subjects with medical, social or psychological factors interfering with compliance of the study 8. 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 9. Female subjects that are lactating, pregnant, or planned to become pregnant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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