A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2- Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
- Conditions
- Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaMedDRA version: 20.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002567-17-GB
- Lead Sponsor
- Astellas Pharma Global Development, Inc. (APGD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 550
General Criteria:
1.Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
approved written informed consent and privacy language as per national
regulations (e.g., Health Insurance Portability and Accountability Act
[HIPAA] Authorization for US sites) must be obtained from the subject
or legally authorized representative (if applicable) prior to any studyrelated
procedures.
2.Subject is considered an adult (e.g., = 18 years of age in the US)
according to local regulation at the time of signing the informed consent.
3.Subject agrees not to participate in another interventional study while
on study treatment.
4.A female subject is eligible to participate if she is not pregnant
(negative serum pregnancy test at Screening; female subjects with
elevated serum beta human chorionic gonadotropin (ßhCG) and a
demonstrated non-pregnant status through additional testing are
eligible) and at least 1 of the following conditions applies:
a.Not a woman of childbearing potential (WOCBP) as defined in
Appendix 12.3 Contraception Requirements
OR
b.WOCBP who agrees to follow the contraceptive guidance as defined in
Appendix 12.3 Contraception Requirements throughout the treatment
period and for at least 6 months after the final study drug
administration.
5.Female subject must agree not to breastfeed starting at Screening and
throughout the study period, and for 6 months after the final study
treatment administration.
6.Female subject must not donate ova starting at Screening and
throughout the study period, and for 6 months after the final study drug
administration.
7.A sexually active male subject with female partner(s) who are of
childbearing potential must agree to use contraception as detailed in
Appendix 12.3 Contraception Requirements during the treatment period
and for at least 6 months after the final study drug administration.
8.Male subject must not donate sperm starting at Screening and
throughout the study period and for 6 months after the final study drug
administration.
9.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
for the time partner is breastfeeding throughout the study period and for
6 months after the final study drug administration.
Disease Specific Criteria:
10.Subject has histologically confirmed diagnosis of Gastric or GEJ
adenocarcinoma.
11.Subject has radiologically confirmed locally advanced unresectable or
metastatic disease within 28 days prior to randomization.
12.Subject has radiologically evaluable disease (measurable and/or nonmeasurable
disease according to RECIST 1.1), per local assessment, =
28 days prior to randomization. For subjects with only 1 evaluable
Prohibited Treatment or Therapies
1.Subject has received prior systemic chemotherapy for locally advanced
unresectable or metastatic gastric or GEJ adenocarcinoma. However,
subject may have received either neo-adjuvant or adjuvant
chemotherapy as long as it was completed at least 6 months prior to
randomization. Subject may have received treatment with herbal
medications that have known antitumor activity > 28 days prior
randomization.
2.Subject has received radiotherapy for locally advanced unresectable or
metastatic gastric or GEJ adenocarcinoma = 14 days prior to
randomization and recovered from any related toxicity.
3.Subject has received systemic immunosuppressive therapy, including
systemic corticosteroids within 14 days prior to randomization. Subjects
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.
4.Subject has received other investigational agents or devices within 28
days prior to randomization.
Medical History or Concurrent Disease
5.Subject has prior severe allergic reaction or intolerance to known
ingredients of zolbetuximab or other monoclonal antibodies, including
humanized or chimeric antibodies.
6.Subject has known immediate or delayed hypersensitivity, intolerance
or contraindication to any component of study treatment.
7. Subject has prior severe allergic reaction or intolerance to any
component of mFOLFOX6.
8.Subject has known dihydropyrimidine dehydrogenase deficiency
(DPD). (NOTE: Screening for DPD deficiency should be conducted per
local requirements.)
9.Subject has a complete gastric outlet syndrome or a partial gastric
outlet syndrome with persistent/recurrent vomiting.
10.Per investigator judgment, subject has significant gastric bleeding
and/or untreated gastric ulcers that exclude the subject from
participation.
11.Subject has a known history of a positive test for human
immunodeficiency virus (HIV) infection or known active hepatitis B
(positive HBs Ag) or C infection. NOTE: Screening for these infections
should be conducted per local requirements.
a.For subjects who are negative for HBs Ag, but HBc Ab positive, an HB
DNA test will be performed and if positive, the subject will be excluded.
b.Subjects with positive hepatitis C (HCV) serology, but negative HCV
RNA test are eligible.
c.Subjects treated with HCV with undetectable viral load results are
eligible.
12.Subject has an active autoimmune disease that has required systemic
treatment within the past 3 months prior to randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method