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Protocol Number8951-CL-0301
NCT Number(ClinicalTrials.gov Identfier)NCT03504397

2018-07-30 - 2020-09-30

Phase III

Recruiting6

Terminated2

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C16

Malignant neoplasm of stomach

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of 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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Astellas Pharma Global Development, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Recruiting

Audit

None

Principal Investigator 陳彥豪 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Tzong Chen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

陳仁熙

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Recruiting

Audit

None

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator I-CHEN WU Division of General Internal Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林正耀 Division of General Internal Medicine
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Objectives

Study Objective(s): Primary • To evaluate the efficacy of IMAB362 plus mFOLFOX6 compared with placebo plus mFOLFOX6 (as first-line treatment) as measured by Progression Free Survival (PFS) in subjects with Claudin (CLDN)18.2 positive, human epidermal growth factor receptor 2 (HER2)–negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma Secondary • To evaluate efficacy as measured by Overall Survival (OS) as a key secondary objective • To evaluate efficacy as measured by Objective Response Rate (ORR) • To evaluate efficacy as measured by Duration of Response (DOR) • To evaluate safety and tolerability of IMAB362 • To evaluate health related quality of life (HRQoL) using the parameters as measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQOG25, Global Pain (GP) and the EuroQOL Five Dimensions Questionnaire 5L (EQ5D-5L) questionnaires • To evaluate the pharmacokinetics of IMAB362 • To evaluate the immunogenicity profile of IMAB362 Exploratory • To evaluate efficacy as measured by Time to Progression (TTP) • To evaluate PFS following subsequent anti-cancer treatment (PFS2) • To evaluate Disease Control Rate (DCR) • To evaluate potential genomic and/or other biomarkers that may correlate with treatment outcome to IMAB362 and mFOLFOX6. • To evaluate Health Resource Utilization (HRU)

Test Drug

IMAB362

Active Ingredient

IMAB362

Dosage Form

Lyophilisate in vial

Dosage

105

Endpoints

Endpoints for Evaluation:
Primary:
• PFS, defined as the time from the date of randomization until the date of radiological PD (per
RECIST 1.1 by IRC) or death from any cause, whichever is earliest

Secondary:
• OS, defined as the time from the date of randomization until the date of death from any cause
• ORR, defined as the proportion of subjects who have a best overall response (BOR) of CR or PR
as assessed by IRC per RECIST 1.1
• DOR, defined as the time from the date of the first response (CR/PR) until the date of PD as
assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest
• Safety and tolerability, as measured by AEs, laboratory test results, vital signs, ECGs, and ECOG
performance status
• HRQoL, as collected via EORTC QLQ-C30, QLQ-OG25, GP and EQ5D-5L questionnaires
• Pharmacokinetics of IMAB362, Cmax and Ctrough
• Immunogenicity of IMAB362 as measured by the frequency of anti-drug antibody (ADA)
positive subjects.
Exploratory:
• TTP, defined as the time from the date of randomization until the date of PD as assessed by IRC
per RECIST 1.1.
• Progression Free Survival 2 (PFS2), defined as the time from the date of randomization until the
date of PD (per investigator) following subsequent anti-cancer therapy, death from any cause or
start of any other anti-cancer therapy, whichever is earliest.
• DCR, defined as the proportion of subjects who have a BOR of stable disease (SD), CR or PR as
assessed by IRC per RECIST 1.1.
• Potential genomic and/or other exploratory biomarkers that may be related to treatment outcome
of IMAB362
• HRU

Inclution Criteria

Inclusion Criteria:
Waivers to the inclusion criteria will NOT be allowed.
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 study-related
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. Female subject must either:
Be of non-childbearing potential:
• postmenopausal (defined as at least 1 year without any menses for which there is
no other obvious pathological or physiological cause) prior to Screening,
• or, documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral
oophorectomy)
Or, if of childbearing potential:
• agree not to try to become pregnant during the study and for 6 months after the final study
treatment administration,
• and, have a negative serum pregnancy test at Screening, (note: subjects with elevated
serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant
status through additional testing are eligible)
• and, if heterosexually active, agree to consistently use 1 form of highly effective birth
control* starting at Screening and throughout the study period and for 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 is eligible
if:
• Agrees to use a male condom starting at screening and continue throughout study treatment
and for 6 months after the final study drug administration.
• If he has not had a vasectomy or is not sterile as defined below, his female partner(s) is
utilizing 1 form of highly effective birth control*starting at Screening and continue
throughout study treatment and for 6 months after the he receives his 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.
*Highly effective forms of birth control include:
• Consistent and correct usage of established hormonal contraceptives that inhibit
ovulation
• Established intrauterine device (IUD) or intrauterine system (IUS)
• Bilateral tubal occlusion
• Vasectomy (a vasectomy is a highly effective contraception method provided the absence
of sperm has been confirmed. If not, an additional highly effective method of
contraception should be used)
• Male is sterile due to a bilateral orchiectomy
• Sexual abstinence is considered a highly effective method only if defined as refraining
from heterosexual activity during the entire period of risk associated with the study drug.
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the
study and the preferred and usual lifestyle of the participant.
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 the first dose of study treatment.
12. Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose
of study treatment. 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.
13. Subject’s tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong
membranous staining as determined by central IHC testing.
14. Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ
tumor specimen.
Physical or Laboratory Findings
15. Subject has ECOG performance status 0 to 1.
16. Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.
17. Subject must meet all of the following criteria based on the centrally analyzed laboratory tests
within 14 days prior to the first dose of study treatment. In case of multiple central laboratory
data within this period, the most recent data should be used to determine eligibility.
• Hemoglobin (Hgb) ≥ 9 g/dl. NOTE: Subject must not have received any growth factor or
blood transfusions within 14 days prior to the hematology values obtained at screening.
Subjects requiring transfusions to meet eligibility criteria are not eligible.
• 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 and alanine aminotransferase ≤ 2.5 x ULN without liver
metastases (or ≤ 5 x ULN if liver metastases are present)
• Either serum creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate
≥ 45 mL/min/1.73 m
2
• Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 x ULN
(except for subjects receiving anticoagulation therapy)

Exclusion Criteria

Exclusion Criteria:
Waivers to the exclusion criteria will NOT be allowed.
Subject who meets any of the following exclusion criteria prior to enrollment is not eligible for
enrollment:
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 neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first
dose of study treatment.
2. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ
adenocarcinoma unless the radiotherapy was completed within 28 days prior to start of study
treatment. Subject who received palliative radiotherapy to peripheral bone metastases ≥ 14 days
prior to start of study treatment and has recovered from all acute toxicities is allowed.
3. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids
within 14 days prior to first dose of study treatment. 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) are allowed.
4. Subject has received other investigational agents or devices within 28 days prior to first dose of
study treatment.
Medical History or Concurrent Disease
5. Subject has prior severe allergic reaction or intolerance to a monoclonal antibody, 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.
9. Subject has gastric outlet syndrome or persistent/recurrent vomiting.
10. Subject with recent gastric bleeding or symptomatic subjects with proven gastric ulcers that
would exclude the subject from participation per investigator judgment.
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. 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. Subjects with positive serology but negative HCV RNA test results are eligible.
12. Subject has an active autoimmune disease that has required systemic treatment within the past
2 years.
13. Subject has active infection requiring systemic therapy that has not completely resolved within
14 days prior to start of study treatment.
14. Subject has significant cardiovascular disease, including:
• Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial
infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft,
cerebrovascular accident or hypertensive crisis within 6 months prior to administration of first
dose of study drug.
• History of clinically significant ventricular arrhythmias (i.e., sustained ventricular
tachycardia, ventricular fibrillation or Torsades de Pointes);
• QTc interval > 450 msec
• Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial
fibrillation for > 1 month prior to first dose of study drugs are eligible)
15. Subject has known active central nervous system metastases and/or carcinomatous meningitis.
16. Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon
reflexes is the sole neurological abnormality.
17. Subject has had a major surgical procedure and has not completely recovered within 28 days prior
to the start of study treatment.
18. Subject has psychiatric illness or social situations that would preclude study compliance, per
investigator judgment.
19. Subject has another malignancy for which treatment is required per investigator’s clinical
judgment.
Subject has any concurrent disease, infection or comorbid 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 in the opinion of the investigator.

The Estimated Number of Participants

  • Taiwan

    43 participants

  • Global

    550 participants

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