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Pancreatic CancerPhase 1/2NCT04381130

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

A Phase 1/2 study testing EF-009 in people with Pancreatic Cancer, run by Everfront Biotech Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
EF-009
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Apr 2027to 30 Jun 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • 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;
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  • 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
  • Solid tumor contact with the CA and aortic involvement
  • 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)
  • Subjects have an ECOG performance status ≤ 1
  • Subjects who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms
  • 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)
  • The subject agrees not to use food supplementary or dietary that contains Angelica sinensis after Screening Visit to Day 21.
  • 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):
  • 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.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

David Liu, PhD contact

+88638630108

coldwee@efbiotech.com

About this study

Official title: A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile 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.

Read the detailed description

In Phase I, the study will follow a "3+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.

Being tested
EF-009
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • EF-009Drug

    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

Study groups in NCT04381130
Study groupRoleWhat they receive
EF-009ExperimentalIn 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.
Receives: Drug: EF-009

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    Phase I

    Measured: 21 days

  2. Overall survival

    Phase IIa

    Measured: 2 years

Secondary outcomes (8)

  1. Progression Free Survival

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  4. Objective response rate

    Measured: 2 years

  5. Best response rate

    Measured: 2 years

  6. Time to objective tumor response

    Measured: 2 years

  7. Tumor response duration

    Measured: 2 years

  8. Change in quality of life assessed with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0

    Measured: 2 years

Timeline

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

  1. First posted8 May 2020
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion30 Jun 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381130
Sponsor's protocol ID
EFBPOLZ20190701
Status last verified
Sep 2026
First submitted
7 May 2020
Last updated
11 Sep 2026
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 EF-009 in people with Pancreatic Cancer, run by Everfront Biotech Co., Ltd..

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 45 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact David Liu, PhD (+88638630108, coldwee@efbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 21 days). The study lists 2 primary outcomes in all. 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 NCT04381130.

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 11 Sep 2026.

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