A Study to Assess the Antitumor Activity and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive Metastatic Pancreatic Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    141
  • sponsor
    Astellas Pharma Global Development, Inc.
Updated on 20 September 2021
Investigator
Medical Affairs Europe
Primary Contact
Site FR33005 (1.6 mi away) Contact
+112 other location
paclitaxel
cancer
tumor markers
measurable disease
fluorouracil
international normalized ratio
metastasis
neutrophil count
pancreatic adenocarcinoma
liver metastasis
tumor cells
gemcitabine
blood transfusion
adjuvant therapy
thromboplastin
cancer chemotherapy
adenocarcinoma
metastatic pancreatic cancer
immunostimulant
metastatic pancreatic adenocarcinoma

Summary

The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment.

This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM.

Description

This study will have a safety lead in phase and a randomization phase.

Details
Condition Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, Pancreatic Disorders, Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Gemcitabine, Nab-paclitaxel, Zolbetuximab
Clinical Study IdentifierNCT03816163
SponsorAstellas Pharma Global Development, Inc.
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies
Not a woman of childbearing potential (WOCBP) OR
WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration
Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration
A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration
A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration
Subject agrees not to participate in other interventional studies while receiving study drug in present study
Subject has histologically or cytologically confirmed adenocarcinoma of pancreas
Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy
Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
If a subject received therapy in the adjuvant setting, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of adjuvant therapy
Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy
Subject's tumor sample has CLDN18.2 expression in 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subject has predicted life expectancy 12 weeks
Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used
Hemoglobin 9 g/dl (no transfusion within 14 days of start of study treatment)
Absolute neutrophil count 1.5 x 10^9/L
Platelets 100 x 10^9/L
Albumin 2.5 g/dL
Total bilirubin 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN without liver metastases ( 5 x ULN if liver metastases are present)
Estimated creatinine clearance 30 mL/min
Prothrombin time/international normalized ratio (INR) and partial thromboplastin time 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria

Subject has received other investigational treatment within 28 days prior to randomization
Subject has received radiotherapy for metastatic pancreatic adenocarcinoma 14 days prior to randomization and has not recovered from any related toxicity
Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed
Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies
Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment
Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements
For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded
Subject has a history of interstitial pneumonia or pulmonary fibrosis
Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible
Subject has pleural effusion or ascites Grade 3
Subjects treated for hepatitis C with undetectable viral load results are eligible
Subject has significant cardiovascular disease, including
Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization
Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization
History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization
Subject has known peripheral sensory neuropathy Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality
Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)
Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma
Psychiatric illness or social situations that would preclude study compliance
Subject has another malignancy for which treatment is required
Subject has had a major surgical procedure 28 days prior to randomization
Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data
Subject without complete recovery from a major surgical procedure 14 days prior to randomization
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