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

  • STATUS
    Recruiting
  • End date
    Aug 9, 2023
  • participants needed
    80
  • sponsor
    Silenseed Ltd
Updated on 1 March 2022
paclitaxel
cancer
measurable disease
endoscopic ultrasound
neutrophil count
gemcitabine
cancer chemotherapy
adenocarcinoma
folfirinox

Summary

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.

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.

Details
Condition Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
Treatment FOLFIRINOX, siG12D-LODER, Gemcitabine+nab-Paclitaxel
Clinical Study IdentifierNCT01676259
SponsorSilenseed Ltd
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age
Subject must be 18 years of age or older at the time of signing the informed consent
Type of Subject and Disease Characteristics
Histologically or cytologically confirmed adenocarcinoma of the pancreas
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
Allocated to receive one of the following chemotherapies: gemcitabine plus nab-paclitaxel, FOLFIRINOX or modified FOLFIRIONOX as first line treatment for pancreatic cancer
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>)
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
\. Eastern Cooperative Oncology Group (ECOG) Performance Scale of 1
\. 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
\. 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

Evidence of metastatic disease
Other malignancy that would interfere with the current intervention
Any evidence of ascites (beyond trace)
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
History of clinically significant coagulopathy
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Subjects are excluded from the study if any of the following criteria apply
Medical Conditions
Females who are pregnant or breast-feeding
Subjects with resectable pancreatic cancer
Bulky celiac adenopathy (2.5 cm) or non-adenocarcinoma histology
Major surgery, other than diagnostic surgery, within 4 weeks prior to study entry without complete recovery
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
Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
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
\. Any prior therapy for the treatment of pancreatic malignancy (including
chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery
or irradiation, whether conventional or investigational)
\. Prior therapy with any hypoxic cytotoxic agent (hypoxia-targeting drugs)
Prior/Concurrent Clinical Study Experience
\. 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
\. Unwillingness or inability to comply with the study protocol for any
reason
\. Known allergy to sesame oil
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