Clinical trials: CLDN18.2 Positive
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the…
- Trial name
- NCT06942767
- Testing
- QLS31905 for Injection, QL2107 Injection, Oxaliplatin Injection
- Volunteers
- 100 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction…
- Trial name
- NCT06351020
- Testing
- LM-302, Apatinib, Irinotecan
- Where
- 2 sites in China
- Volunteers
- 387 people
- Sponsor
- LaNova Medicines Zhejiang Co., Ltd.
Advanced Solid Tumors
Study of LM-102 in Subjects in Advanced Tumors
This is a phase Ⅰ, first-in-human, open-label, dose escalation study to evaluate the safety and tolerability, PK, immunogenicity and preliminary anti-tumor activity of LM-102 injection in subjects with CLDN18.2-positive advanced…
- Trial name
- NCT04735796
- Testing
- Drug：LM-102
- Where
- 6 sites in United States
- Volunteers
- 9 people
- Sponsor
- LaNova Medicines Limited
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
CLDN18.2-positive Advanced Solid Tumor
SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive…
- Trial name
- NCT06350006
- Testing
- SHR-A1904; Adebrelimab, SHR-A1904; CAPOX; Adebrelimab
- Where
- China
- Volunteers
- 924 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
CLDN18.2 Positive Solid Tumors
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345
A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors
- Trial name
- NCT05199519
- Testing
- IBI345
- Where
- China
- Volunteers
- 7 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Claudin 18.2, Solid Tumor Malignancies
A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors
This open-label, multicenter Phase I/II trial evaluates the combination of FG-M108 and FG-B901 in patients with unresectable locally advanced or metastatic solid tumors that are positive for Claudin 18.2 and have progressed on…
- Trial name
- NCT07704866
- Testing
- FG-B901, FG-M108
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
Advanced Solid Tumor
Study of LM-102 in Patients With Advance Solid Tumors
This is an open label Phase I/II trial of LM-102 injection, a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2).
- Trial name
- NCT05008445
- Testing
- LM-102 Injection, LM-102 Injection combined with SOC
- Where
- China
- Volunteers
- 11 people
- Sponsor
- LaNova Medicines Development Co., Ltd.
Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer
LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study
In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma
- Trial name
- NCT07556640
- Testing
- LM-302, S-1, paclitaxel, LM-302, Cadonilimab, S-1, paclitaxel
- Where
- China
- Volunteers
- 74 people
- Sponsor
- Ruijin Hospital
Biliary Tract Cancer, Candonilimab
Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody
In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1 monoclonal antibody and CTLA-4 monoclonal antibody bisspecific antibodies) and LM-302 (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC…
- Conditions
- Biliary Tract Cancer, Candonilimab, Claudin 18.2
- Trial name
- NCT05994001
- Testing
- cardonilizumab, LM-302
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Shanghai Zhongshan Hospital
Solid Tumor, Adult
Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.
- Trial name
- NCT04989010
- Testing
- 89Zr-NY005
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Wuxi No. 4 People's Hospital
Advanced Solid Tumor
A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin…
- Trial name
- NCT06038396
- Testing
- RC118, Toripalimab, RC148
- Where
- 18 sites in China
- Volunteers
- 48 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumors
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory…
- Trial name
- NCT07460375
- Testing
- LCB02A
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 191 people
- Sponsor
- LigaChem Biosciences, Inc.
Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a randomized, controlled, open-label, multicenter Phase III study to evaluate the efficacy and safety of ATG-022 compared with Investigator's Choice in participants with CLDN18.2-positive advanced gastric or…
- Trial name
- CLINCH-3 (NCT07795346)
- Testing
- ATG-022, Docetaxel or Irinotecan
- Where
- 114 sites in China
- Volunteers
- 380 people
- Sponsor
- Antengene Biologics Limited
Pancreatic Cancer, Chemotherapy Effect
Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer.
- Trial name
- NCT07108504
- Testing
- Gemcitabine, LM-302
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
Biliary Tract Neoplasms
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive…
- Trial name
- NCT05190575
- Testing
- TST001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Shanghai Zhongshan Hospital
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer.
- 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
- LUCERNA (NCT06901531)
- Testing
- zolbetuximab, Pembrolizumab, Capecitabine
- Where
- 252 sites in United States, Australia and 20 more
- Volunteers
- 500 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Gastric Adenocarcinoma
A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer.
- Trial name
- NCT07103668
- Testing
- CAR T cells, Control
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
Pancreatic Cancer, Borderline Resectable Pancreatic Adenocarcinoma
IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC).
- Trial name
- NCT07415525
- Testing
- IBI343
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Zhejiang University
CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced…
- Conditions
- CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus
- Trial name
- PILOT (NCT01671774)
- Testing
- IMAB362, Zoledronic acid, Interleukin-2 (1 million IU)
- Where
- 9 sites in Germany, Latvia
- Volunteers
- 29 people
- Sponsor
- Astellas Pharma Global Development, Inc.