Zolbetuximab

Generic Name: Zolbetuximab

Brand Names: Vyloy

Drug Type: Biotech

CAS Number: 1496553-00-4

Unique Ingredient Identifier: TF5MPQ8WGY

Background: Zolbetuximab is under investigation in clinical trial NCT01630083 (Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer).

Clinical Trials

Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

Phase 2

Not yet recruiting

Conditions: Gastric Cancer Adenocarcinoma Metastatic
Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: zolbetuximab
Other: Retrospective cohort, no intervention

First Posted Date: 2025-05-08

Last Posted Date: 2025-05-08

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 100

Registration Number: NCT06962137

Locations: 🇧🇪
UZA, Antwerp, Belgium
🇧🇪
HUB, Brussels, Belgium
🇧🇪
Cliniques Universitaires Saint-Luc Brussels, Brussels, Belgium

and more 3 locations

A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

Recruiting

Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions: Drug: zolbetuximab

First Posted Date: 2025-03-30

Last Posted Date: 2025-05-01

Lead Sponsor: Astellas Pharma Korea, Inc.

Target Recruit Count: 377

Registration Number: NCT06902545

Locations: 🇰🇷
KR82001, Seoul, Korea, Republic of

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Phase 3

Not yet recruiting

Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions: Drug: zolbetuximab
Drug: Pembrolizumab
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Folinic acid (leucovorin or local equivalent)
Drug: 5-fluorouracil (5-FU)
Drug: Placebo

First Posted Date: 2025-03-30

Last Posted Date: 2025-05-14

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 500

Registration Number: NCT06901531

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Phase 2

Not yet recruiting

Conditions: Gastric Cancer
HER2 + Gastric Cancer
PD-L1 Positive
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction

Interventions: Drug: Trastuzumab
Drug: Capecitabine
Drug: Apatinib
Drug: Adebrelimab
Drug: SHR-A1811
Drug: Oxaliplatin
Drug: S-1
Drug: SHR-A1904
Drug: SHR-1701
Drug: zolbetuximab

First Posted Date: 2025-03-18

Last Posted Date: 2025-03-18

Lead Sponsor: China Medical University, China

Target Recruit Count: 140

Registration Number: NCT06881017

A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients with Locally Advanced Gastric Cancer

Phase 1

Not yet recruiting

Conditions: Stomach Neoplasm
Gastric (Stomach) Cancer

Interventions: Drug: zolbetuximab
Drug: Oxaliplatin
Drug: Docetaxel
Drug: S-1

First Posted Date: 2024-12-13

Last Posted Date: 2024-12-20

Lead Sponsor: Asan Medical Center

Target Recruit Count: 57

Registration Number: NCT06732856

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Phase 1

Recruiting

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: zolbetuximab
Drug: mFOLFIRINOX

First Posted Date: 2024-05-02

Last Posted Date: 2025-04-11

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 12

Registration Number: NCT06396091

Locations: 🇺🇸
Providence Medical Foundation, Fullerton, California, United States
🇺🇸
Norton Cancer Institute, Louisville, Kentucky, United States
🇺🇸
Virginia Mason Medical Center, Seattle, Washington, United States

and more 2 locations

Early Access Program for Zolbetuximab

Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma Cancer
Metastatic Gastric Adenocarcinoma Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

First Posted Date: 2023-09-21

Last Posted Date: 2025-04-01

Lead Sponsor: Astellas Pharma Global Development, Inc.

Registration Number: NCT06048081

Locations: 🇰🇷
KR82004, Incheon, Korea, Republic of
🇰🇷
KR82008, Seongnam-Si, Korea, Republic of
🇰🇷
KR82001, Seoul, Korea, Republic of

and more 88 locations

A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Phase 1

Completed

Conditions: Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Interventions: Drug: zolbetuximab

First Posted Date: 2019-09-12

Last Posted Date: 2024-11-20

Lead Sponsor: Astellas Pharma China, Inc.

Target Recruit Count: 12

Registration Number: NCT04086758

Locations: 🇨🇳
Site CN86001, Guangzhou, China

A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Phase 2

Active, not recruiting

Conditions: Pancreatic Cancer
Metastatic Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: zolbetuximab
Drug: nab-paclitaxel
Drug: gemcitabine

First Posted Date: 2019-01-25

Last Posted Date: 2025-04-27

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 393

Registration Number: NCT03816163

Locations: 🇺🇸
Lynn Cancer Institute, Boca Raton, Florida, United States
🇹🇷
Site TR90002, Istanbul, Turkey
🇺🇸
St. Joseph Heritage Medical Group, Fullerton, California, United States

and more 133 locations

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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 (GLOW).

Phase 3

Active, not recruiting

Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions: Drug: zolbetuximab
Drug: oxaliplatin
Drug: capecitabine
Drug: placebo

First Posted Date: 2018-08-31

Last Posted Date: 2025-04-16

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 507

Registration Number: NCT03653507

Locations: 🇺🇸
Parkland Hospital, Dallas, Texas, United States
🇺🇸
University of Kansas Cancer Center and Medical Pavilion, Fairway, Kansas, United States
🇵🇹
Site PT35109, Braga, Portugal

and more 162 locations

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