A Study to Assess the Efficacy 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

• ClinicalTrials.gov Identifier: NCT03816163
• Recruitment Status: Active, not recruiting
• First Posted: January 25, 2019
• Last Update Posted: April 19, 2024
• Sponsor: Astellas Pharma Global Development, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description

Brief 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 tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma	Drug: zolbetuximab; Drug: nab-paclitaxel; Drug: gemcitabine	Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 393 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (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
• Actual Study Start Date: March 15, 2019
• Estimated Primary Completion Date: September 30, 2024
• Estimated Study Completion Date: April 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: zolbetuximab +nab-paclitaxel + gemcitabine; Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.	Drug: zolbetuximab; Administered as an intravenous infusion.; Other Name: IMAB362; Drug: nab-paclitaxel; Administered as an intravenous infusion; Drug: gemcitabine; Administered as an intravenous infusion
Active Comparator: nab-paclitaxel + gemcitabine; Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.	Drug: nab-paclitaxel; Administered as an intravenous infusion; Drug: gemcitabine; Administered as an intravenous infusion

Outcome Measures

Primary Outcome Measures :

1. Dose Limiting Toxicities (DLT) - (safety lead in) [ Time Frame: Up to 28 days ]
   Incidence of dose limiting toxicities.
2. Overall Survival (OS) [ Time Frame: Up to 65 months ]
   OS is defined as the time from the date of randomization until the date of death from any cause.
3. Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 65 months ]
   An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
4. Safety assessed by incidence of serious adverse events (SAE) [ Time Frame: Up to 65 months ]
   Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
5. Safety assessed by incidence of treatment emergent adverse events (TEAE) [ Time Frame: Up to 65 months ]
   Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
6. Number of participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to 65 months ]
   Number of participants with potentially clinically significant laboratory values.
7. Number of participants with vital sign abnormalities and /or adverse events (AEs) [ Time Frame: Up to 65 months ]
   Number of participants with potentially clinically significant vital sign values.
8. Number of participants with electrocardiograms (ECG) abnormalities and or adverse events [ Time Frame: Up to 65 months ]
   12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
9. Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events [ Time Frame: Up to 65 months ]
   Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

Secondary Outcome Measures :

1. Progression Free Survival (PFS) [ Time Frame: Up to 65 months ]
   PFS is defined as the time from the date of randomization until the date of radiological progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by investigator evaluation or death from any cause, whichever is earliest.
2. Objective Response Rate (ORR) [ Time Frame: Up to 65 months ]
   ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
3. Number of anti-drug antibody (ADA) Positive Participants [ Time Frame: Up to 65 months ]
   Immunogenicity will be measured by the number of participants that are ADA positive.
4. Disease Control Rate (DCR) [ Time Frame: Up to 65 months ]
   DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
5. Duration Of Response (DOR) [ Time Frame: Up to 65 months ]
   DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.
6. Change in CA (Cancer Antigen) 19-9 [ Time Frame: Baseline up to 65 months ]
   Change from baseline in serum CA19-9 will be assessed.
7. PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough) [ Time Frame: Up to 65 months ]
   Ctrough will be derived from the PK serum samples collected.
8. PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf) [ Time Frame: Up to 30 days ]
   AUCinf will be derived from the PK plasma samples collected.
9. PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast) [ Time Frame: Up to 30 days ]
   AUClast will be derived from the PK plasma samples collected.
10. PK of Nab-P: Maximum Concentration (Cmax) [ Time Frame: Up to 30 days ]
    Cmax will be derived from the PK plasma samples collected.
11. PK of Nab-P: Time of Maximum Concentration (Tmax) [ Time Frame: Up to 30 days ]
    Tmax will be derived from the PK plasma samples collected.
12. PK of Nab-P: Terminal Elimination Half-life (T1/2) [ Time Frame: Up to 30 days ]
    T1/2 will be derived from the PK plasma samples collected.
13. PK of Nab-P: Clearance (CL) [ Time Frame: Up to 30 days ]
    CL will be derived from the PK plasma samples collected.
14. PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz) [ Time Frame: Up to 30 days ]
    Vz will be derived from the PK plasma samples collected.
15. PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf) [ Time Frame: Up to 30 days ]
    AUCinf will be derived from the PK plasma samples collected.
16. PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast) [ Time Frame: Up to 30 days ]
    AUClast will be derived from the PK plasma samples collected.
17. PK of gemcitabine: Maximum Concentration (Cmax) [ Time Frame: Up to 30 days ]
    Cmax will be derived from the PK plasma samples collected.
18. PK of gemcitabine: Time of Maximum Concentration (Tmax) [ Time Frame: Up to 30 days ]
    Tmax will be derived from the PK plasma samples collected.
19. PK of gemcitabine: Terminal Elimination Half-life (T1/2) [ Time Frame: Up to 30 days ]
    T1/2 will be derived from the PK plasma samples collected.
20. PK of gemcitabine: Clearance (CL) [ Time Frame: Up to 30 days ]
    CL will be derived from the PK plasma samples collected.
21. PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz) [ Time Frame: Up to 30 days ]
    Vz will be derived from the PK plasma samples collected.
22. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30) [ Time Frame: Up to 65 months ]
    The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
23. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26) [ Time Frame: Up to 65 months ]
    EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
24. Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) [ Time Frame: Up to 65 months ]

    The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.

    Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

25. Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale [ Time Frame: Up to 65 months ]
    The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
26. Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale [ Time Frame: Up to 65 months ]
    The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy.
  • Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible.
• 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.

  1. 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.
  2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible.
  3. Subjects treated for hepatitis C with undetectable viral load results are eligible.
• Subject has a history of interstitial pneumonia or pulmonary fibrosis.
• Subject has pleural effusion or ascites ≥ Grade 3.
• 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.

• 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, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months 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;
  • 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.
• Subject has known peripheral sensory neuropathy ≥ Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality.
• Subject has had a major surgical procedure ≤ 28 days prior to randomization.
• Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
• Psychiatric illness or social situations that would preclude study compliance.
• Subject has another malignancy for which treatment is required.
• 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.

Contacts and Locations

Locations

United States, California

St. Joseph Heritage Medical Group

Fullerton, California, United States, 92835

TOI Clinical research

Whittier, California, United States, 90603

United States, Connecticut

Midstate Medical Center

Meriden, Connecticut, United States, 06451

United States, Florida

Lynn Cancer Institute

Boca Raton, Florida, United States, 33486

Baptist Health

Miami, Florida, United States, 33176

United States, Georgia

Cancer Treatment Centers of Atlanta

Newnan, Georgia, United States, 30265

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

United States, Kentucky

Norton Cancer Institute (NCI)

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Health System

New Orleans, Louisiana, United States, 70121

United States, Missouri

David C Pratt Cancer Center

Creve Coeur, Missouri, United States, 63141

United States, New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14203

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

Northwell Health Cancer Institute

Lake Success, New York, United States, 11042

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10022

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

United States, North Carolina

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States, 28204

Novant Health

Winston-Salem, North Carolina, United States, 27103

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

United States, Utah

Utah Cancer Specialists

Salt Lake City, Utah, United States, 84106

United States, Washington

MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, United States, 98335

Vista Oncology

Olympia, Washington, United States, 98502

Virginia Mason

Seattle, Washington, United States, 98101

Australia, New South Wales

Site AU61008

Gosford, New South Wales, Australia, NSW 2250

Site AU61007

Wollongong, New South Wales, Australia, HVGM+3C

Australia, Victoria

Site AU61005

Fitzroy, Victoria, Australia, 5XRF+WX

Site AU61006

Warrnambool, Victoria, Australia, VIC 3280

Brazil

Site BR55012

Porto Alegre, Rio Grande Do Sul, Brazil

Site BR55009

Centro Passo Fundo, Brazil

Site BR55008

Rio Grande Do Sul, Brazil

Site BR55004

Santa Catarina, Brazil

Site BR55010

Sao Paulo, Brazil

Site BR55011

Sao Paulo, Brazil

China

Site CN86001

Beijing, China

Site CN86008

Beijing, China

Site CN86014

Beijing, China

Site CN86026

Changchun, China

Site CN86009

Chongqing, China

Site CN86004

Guangdong, China

Site CN86020

Guangdong, China

Site CN86016

Guangzhou, China

Site CN86012

Harbin, China

Site CN86002

Hubei, China

Site CN86005

Jiangsu, China

Site CN86011

Jiangsu, China

Site CN86025

Jiangsu, China

Site CN86024

Shan XI, China

Site CN86023

Shandong, China

Site CN86006

Shanghai, China

Site CN86013

Shanghai, China

Site CN86019

Shanghai, China

Site CN86007

Tianjin, China

Site CN86022

Xinjiang, China

Site CN86003

Zhejiang, China

Site CN86018

Zhejiang, China

Site CN86010

Zhengzhou, China

France

Site FR33008

Besancon, Besancon Cedex, France, 6XG7+42

Site FR33010

Brest, Brest Cedex, France, 9GV7+4G

Site FR33015

Caen, Cedex 5, France, 14076

Site FR33006

Chambray, Cedex 9, France, 37170

Site FR33012

Herblain, Herblain Cedex, France, 44805

Site FR33016

La Chaussee Saint Victor, Loir-et-Cher, France, 41260

Site FR33009

Nancy, Nancy Cedex, France, 54000

Site FR33017

Rouen, Normandy, France, 76000

Site FR33003

Aquitaine, Pessac, France, 33604

Site FR33013

Villejuif, Villejuif Cedex, France, 94805

Site FR33001

Bayonne Cedex, France, 64109

Site FR33018

Bordeaux, France

Site FR33002

Grenoble, France

Site FR33021

Nice Cedex 2, France

Site FR33023

Pierre Benite, France

Site FR33014

Plerin, France, 22190

Site FR33005

Pringy Cedex, France, 74374

Site FR33019

Roche-Sur-Yon, France

Site FR33007

Strasbourg, France, 67000

Ireland

Site IR35301

Elm Park, Dublin, Ireland, D04 T6F4

Italy

Site IT39006

Rozzano, Milan, Italy, 20089

Site IT39004

Candiolo, Torino, Italy, 10060

Site IT39002

Cremona, Italy, 26100

Site IT39010

Lombardia, Italy

Site IT39003

Milan, Italy, 20141

Site IT39014

Toscana, Italy

Site IT39008

Veneto, Italy

Japan

Site JP81007

Nagoya, Aichi, Japan

Site JP81001

Kashiwa, Chiba, Japan

Site JP81005

Sapporo, Hokkaido, Japan

Site JP81006

Yokohama, Kanagawa, Japan

Site JP81003

Kashihara, Nara, Japan

Site JP81011

Bunkyo-ku, Tokyo, Japan

Site JP81012

Chuo-ku, Tokyo, Japan

Site JP81014

Koto-ku, Tokyo, Japan

Site JP81013

Mitaka, Tokyo, Japan

Site JP81002

Shinjuku-ku, Tokyo, Japan

Site JP81015

Ube, Yamaguchi, Japan

Site JP81004

Fukuoka, Japan

Site JP81010

Osaka, Japan

Site JP81009

Wakayama, Japan

Korea, Republic of

Site KR82005

Seongnam-Si, Gyeonggi-do, Korea, Republic of, 013620

Site KR82008

Suwon-si, Gyeonggi-do, Korea, Republic of

Site KR82010

Daegu, Korea, Republic of

Site KR82009

Gyeonggi-do, Korea, Republic of

Site KR82011

Jeollanam-do, Korea, Republic of

Site KR82001

Seoul, Korea, Republic of, 03080

Site KR82003

Seoul, Korea, Republic of, 120-752

Site KR82004

Seoul, Korea, Republic of, 138-736

Site KR82007

Seoul, Korea, Republic of, 152-703

Site KR82002

Seoul, Korea, Republic of, F3QP+76

Site KR82006

Seoul, Korea, Republic of, G234+36

Mexico

Site MX52004

Distrito Federal, Mexico

Site MX52003

San Luis Potosi, Mexico

Site MX52005

Veracruz, Mexico

Spain

Site ES34004

Llobregat, Barcelona, Spain, 08908

Site ES34003

Pamplona, Navarra, Spain, 31008

Site ES34010

Barcelona, Spain, 08028

Site ES34013

Barcelona, Spain, 08036

Site ES34007

Barcelona, Spain, 08916

Site ES34018

Barcelona, Spain

Site ES34021

Barcelona, Spain

Site ES34014

Caceres, Spain, 10003

Site ES34022

Cordoba, Spain

Site ES34005

Lleida, Spain, 25198

Site ES34015

Madrid, Spain, 28027

Site ES34006

Madrid, Spain, 28033

Site ES34009

Madrid, Spain, 28034

Site ES34026

Malaga, Spain

Site ES34024

Santander, Spain

Site ES34017

Santiago de Compostela, Spain

Taiwan

Site TW88608

New Taipei City, Taiwan

Site TW88602

Taichung City, Taiwan, 5M5J+36

Site TW88601

Taipei City, Taiwan, 4G9C+W3

Site TW88609

Taipei City, Taiwan

Turkey

Site TR90004

Ankara, Turkey

Site TR90006

Ankara, Turkey

Site TR90003

Diyarbakir, Turkey

Site TR90002

Istanbul, Turkey

Site TR90001

Konya, Turkey

Sponsors and Collaborators

Astellas Pharma Global Development, Inc.

Investigators

• Study Director: Medical Director; Astellas Pharma Global Development

More Information

• Responsible Party: Astellas Pharma Global Development, Inc.
• ClinicalTrials.gov Identifier: NCT03816163
• Other Study ID Numbers: 8951-CL-5201; 2018-002551-15 ( EudraCT Number ); CTR20220914 ( Registry Identifier: ChinaDrugTrials.org.cn )
• First Posted: January 25, 2019
• Last Update Posted: April 19, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• URL: https://www.clinicalstudydatarequest.com/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

metastatic pancreatic cancer; IMAB362; nab-paclitaxel; gemcitabine; zolbetuximab; metastatic pancreatic adenocarcinoma; pancreatic cancer; CLDN 18.2

Additional relevant MeSH terms:

Adenocarcinoma; Pancreatic Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Paclitaxel; Gemcitabine; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites