Clinical trials: CLDN18.2 Positive
Gastric Cancer, HER2 + Gastric Cancer
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling…
- Conditions
- Gastric Cancer, HER2 + Gastric Cancer, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, PD-L1 Positive
- Trial name
- NCT06881017
- Testing
- Trastuzumab, Adebrelimab, Apatinib
- Volunteers
- 140 people
- Sponsor
- China Medical University, China
Solid Tumor
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
- Trial name
- NCT06041035
- Testing
- QLS31905, Nab paclitaxel, Gemcitabine
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Malignant Neoplasms of Digestive Organs
A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
- Trial name
- NCT05934331
- Testing
- LM-302, Toripalimab, Capecitabine
- Where
- China
- Volunteers
- 632 people
- Sponsor
- LaNova Medicines Zhejiang Co., Ltd.
Adenocarcinoma
Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.
This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or…
- Trial name
- NCT07385703
- Testing
- LM-302 Injection, Tislelizumab, Oxaliplatin Injection
- Where
- 106 sites in China
- Volunteers
- 752 people
- Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens.
- Trial name
- DUPLICATE (NCT07427992)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- European Institute of Oncology
Locally Advanced Unresectable or Metastatic Solid Tumors
SG1906 for CLDN18.2-Positive Solid Tumors
This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
- Trial name
- CSG-1906-101 (NCT05857332)
- Testing
- SG1906
- Where
- 9 sites in China
- Volunteers
- 60 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
CLDN18.2 Positive Solid Tumors
An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
- Trial name
- NCT07680257
- Testing
- SUV2208A cell injection, SUV2208A
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Celest Therapeutics (Shanghai) Co., Ltd.
Advanced Solid Tumor
Study of LM-302 in Patients With Advance Solid Tumors
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors
- Trial name
- NCT05161390
- Testing
- LM-302 Injection
- Where
- China
- Volunteers
- 153 people
- Sponsor
- LaNova Medicines Zhejiang Co., Ltd.
Gastric Cancer, Pancreatic Cancer
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
- Conditions
- Gastric Cancer, Pancreatic Cancer, Advanced Ovarian Carcinoma, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT05472857
- Testing
- Claudin 18.2 CAR-T
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
Pancreatic Cancer
ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic…
- Trial name
- NCT07444541
- Testing
- ANO31905, AG [gemcitabine+nab-paclitaxel], mFOLFIRINOX [Oxaliplatin+irinotecan+leucovorin+fluorouracil]
- Where
- 3 sites in United States
- Volunteers
- 84 people
- Sponsor
- Anova Innovation Limited
Gastric Cancer Adenocarcinoma Metastatic, Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
This study examines whether adding the drug Zolbetuximab to an existing treatment (Paclitaxel and Ramucirumab) can improve patients' survival.
- Trial name
- RAINSPOT (NCT06962137)
- Testing
- zolbetuximab, Retrospective cohort, no intervention
- Where
- 6 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Gastric and Gastroesophageal Junction Adenocarcinoma
Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
- Trial name
- NCT04260191
- Testing
- AMG 910
- Where
- 20 sites in United States, Austria and 7 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Metastatic Pancreatic Adenocarcinoma
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic).
- Trial name
- NCT06396091
- Testing
- zolbetuximab, mFOLFIRINOX
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumor
Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer.
- Trial name
- NCT06084286
- Testing
- Dual-targeting CLDN18.2 and PD-L1 CAR-T cells
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Sichuan University
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
There is an unmet medical need to treat people with advanced cancer in the stomach, or where the food pipe joins the stomach. These conditions are known as advanced gastric cancer or advanced gastroesophageal cancer (GEJ for…
- 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
- Trial name
- RADIANCE (NCT07858500)
- Testing
- Zolbetuximab Exposure, Platinum-based Chemotherapy Exposure, 1L Treatment Not Containing Zolbetuximab Exposure
- Where
- Canada
- Volunteers
- 1,000 people
- Sponsor
- Astellas Pharma Europe Ltd.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer
Early Access Program for Zolbetuximab
This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or…
- Conditions
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, Metastatic Gastric Adenocarcinoma Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Trial name
- NCT06048081
- Testing
- zolbetuximab
- Where
- 140 sites in United States, Brazil and 4 more
- Sponsor
- Astellas Pharma Global Development, Inc.
CLDN18.2-positive Advanced Biliary Tract Cancer
Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive…
- Trial name
- NCT07151872
- Testing
- QLS31905 for Injection, Gemcitabine Hydrochloride for Injection, Cisplatin for Injection
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Solid Tumor, Advanced Cancer
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma).
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer
- Trial name
- NCT07432295
- Testing
- Givastomig, Nivolumab, 5Fluorouracil
- Where
- 6 sites in United States, China and 1 more
- Volunteers
- 180 people
- Sponsor
- I-Mab Biopharma US Limited
Gastric or Esophagogastric Junction Adenocarcinoma
Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma
In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma.
- Trial name
- NCT07569068
- Testing
- Tislelizumab, LM-302 and S-1, Tislelizumab combined with oxaliplatin and S-1
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Ruijin Hospital
Metastatic Solid Tumor
TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2.
- Trial name
- TACTIC-3 (NCT05862324)
- Testing
- TAC01-CLDN18.2
- Where
- 9 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Triumvira Immunologics, Inc.