Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
NCT07427992 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70
Last updated 2026-02-23
Summary
The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens. Specific clinical issues will be studied by pre-planned subgroup analyses, addressing practical clinical needs which have not been specifically investigated in randomized clinical trials.
Conditions
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
Sponsors & Collaborators
-
European Institute of Oncology
lead OTHER
Principal Investigators
-
Nicola Fazio, MD · IEO
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-20
- Primary Completion
- 2026-12-30
- Completion
- 2027-06-30
Countries
- Italy
Study Locations
More Related Trials
-
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT03504397 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as Postoperative Adjuvant Regimens in Patients With Resectable Gastric Cancer/Adenocarcinoma of the Esophagogastric Junction After Radical Surgery
NCT07149181 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010
NCT05867121 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
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).
NCT03653507 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
NCT01630083 ·Status: COMPLETED ·Phase: PHASE2
-
First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy
NCT07400315 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer
NCT01748773 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma
NCT05268510 ·Status: COMPLETED ·Phase: PHASE2
-
KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma
NCT05985707 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
NCT07018570 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
NCT03505320 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT05702229 ·Status: RECRUITING ·Phase: PHASE2
-
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
NCT07194005 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
NCT06551142 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
NCT01130337 ·Status: COMPLETED ·Phase: PHASE2
-
Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer
NCT06693128 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
NCT06773312 ·Status: RECRUITING ·Phase: PHASE1
-
Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma
NCT02445209 ·Status: COMPLETED ·Phase: PHASE3
-
Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer
NCT01876927 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
NCT01590719 ·Status: COMPLETED ·Phase: PHASE2
-
Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
NCT05291052 ·Status: UNKNOWN ·Phase: PHASE2
-
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
NCT01053390 ·Status: COMPLETED ·Phase: PHASE3
-
Apatinib Plus XELOX as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
NCT03229096 ·Status: UNKNOWN ·Phase: PHASE2
-
Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer
NCT07132528 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive
NCT01503983 ·Status: COMPLETED ·Phase: PHASE2