A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer (PROTACT)

June 30, 2021 updated by: Silenseed Ltd

A Prospective, Multinational, Multi-Center, Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy, Safety and Tolerability of siG12D-LODER in Combination With Standard of Care Chemotherapy in the Treatment of Patients With Locally Advanced Pancreatic Cancer

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable or borderline resectable locally advanced pancreatic cancer combined with chemotherapy treatment.

Primary Outcome:

- ORR at 6 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable or borderline resectable LAPC combined with chemotherapy treatment (Gemcitabine+nab-Paclitaxel or Folfirinox or modified Folfirinox). This will be a study to assess the response rate of the siG12D-LODER in patients with unresectable or borderline resectable LAPC. The study is of a single arm design with one arm receiving siG12D-LODER + chemotherapy.

The investigational agent siG12D-LODER is a miniature biodegradable bio polymeric matrix that encompasses the drug, designed and produced by Silenseed Ltd. The implantation of LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.

siG12D-LODER has been studied in the escalating dose Phase I study of 15 patients, and results showed high safety and tolerability profiles, with no single DLT.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

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: Orit Pollack-Shragai, MSc, MBA
  • Phone Number: +972-52-8466267
  • Email: orit@silenseed.com

Study Locations

  • Israel
      • Haifa, Israel, 3525408
        • Recruiting
        • Rambam Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valerya Semenysty, MD
        • Sub-Investigator:
          • Iyad Khamaysi, MD
      • Petah Tikva, Israel, 49102
        • Completed
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Sheba Medical Center (Tel H'shomer)
        • Principal Investigator:
          • Talia Golan, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Maor Lahav, MD
      • Tel Aviv, Israel
      • Tzrifin, Israel, 70300
        • Active, not recruiting
        • Assaf Harofeh Medical Center
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Hackensack Meridian Health
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eileen M. O'Reilly, MD
        • Principal Investigator:
          • Anna M Varghese, MD
        • Principal Investigator:
          • Mark A Schattner, MD
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Celina Ang, MD
        • Principal Investigator:
          • Christopher J DiMaio, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Manoop Bhutani, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Milind Javle, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age

1. Subject must be 18 years of age or older at the time of signing the informed consent.

Type of Subject and Disease Characteristics

  1. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
  2. Locally advanced pancreatic cancer stage III according to The American Joint Committee on Cancer (AJCC) and defined as T4, N (any) and M0, according to the three factors, T (tumor), N (node involvement), and M (metastases), of the National Comprehensive Cancer Network TNM classification.
  3. Allocated to receive one of the following chemotherapies: gemcitabine plus nab-paclitaxel, FOLFIRINOX or modified FOLFIRIONOX as first line treatment for pancreatic cancer.
  4. Have a target tumor that is accessible for intratumoral administration by EUS as determined by the radiologist/gastroenterologist performing the EUS intratumoral administration, according to The American Society for Gastrointestinal Endoscopy (ASGE) guidelines (https://www.asge.org/home/practice-support/guidelines).

  5. Have measurable disease. Subject will have a histologically-confirmed disease and must have clinically and/or radiographically documented measurable primary disease according to RECIST v1.1. At least one site of disease must be unidimensionally measurable.

    Diagnostic Assessments

  6. Eastern Cooperative Oncology Group (ECOG) Performance Scale of ≤ 1.

  7. Demonstrate adequate organ function as defined below:

    • serum creatinine <1.6 mg/dL
    • international normalized ratio (INR) < 1.5 U
    • absolute neutrophil count (ANC) > 1.5 x 109/L
    • platelets ≥ 100 x 109/L
    • hemoglobin ≥ 9 mg/dL
    • alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal (ULN)
    • bilirubin ≤ 1.5 x ULN Sex
  8. Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  9. Women of childbearing potential (WOCBP): a negative serum or urine pregnancy test during screening.

  10. Subject of childbearing potential, if sexually active (both men and women) must agree to use a barrier method of contraception, from the time of administration of the first treatment and for at least 8 weeks after EOT visit day.

    Informed Consent

  11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

Medical Conditions

  1. Subjects with resectable pancreatic cancer.
  2. Evidence of metastatic disease.
  3. Other malignancy that would interfere with the current intervention.
  4. Any evidence of ascites (beyond trace).
  5. Bulky celiac adenopathy (≥2.5 cm) or non-adenocarcinoma histology.
  6. Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years.
  7. History of clinically significant coagulopathy.
  8. Major surgery, other than diagnostic surgery, within 4 weeks prior to study entry without complete recovery.
  9. New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 4 months prior to the first chemotherapy cycle Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease.
  10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  11. Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
  12. Females who are pregnant or breast-feeding.

  13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.

    Prior/Concomitant Therapy

  14. Any prior therapy for the treatment of pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  15. Prior therapy with any hypoxic cytotoxic agent (hypoxia-targeting drugs). Prior/Concurrent Clinical Study Experience

  16. Subjects who are participating or participated in an investigational drug or device study (within 28 days prior to study entry from the last study dose date).

    Other Exclusions:

  17. Unwillingness or inability to comply with the study protocol for any reason.
  18. Known allergy to sesame oil.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: siG12D-LODER + chemotherapy
Eight siG12D-LODER+Gemcitabine+nab-Paclitaxel or Eight siG12D-LODER+Folfirinox or Eight siG12D-LODER+modifide Folfirinox
Drug: siG12D-LODER
The implantation of siG12D-LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.
Drug: Gemcitabine+nab-Paclitaxel
Gemcitabine+nab-Paclitaxel
Other Names:
  • Chemotherapy
Drug: Folfirinox
Folfirinox or modified Folfirinox
Other Names:
  • Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ORR at 6 months
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Silenseed Ltd

Investigators

  • Principal Investigator: Talia Golan, MD, Sheba Medical Center

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start (Actual)

March 7, 2018

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLSG12D-P2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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