Clinical trials: HER2 Positive Gastric Cancer
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma…
- Trial name
- NCT04704934
- Testing
- Trastuzumab deruxtecan, Ramucirumab, Paclitaxel
- Where
- 156 sites in Argentina, Belgium and 22 more
- Volunteers
- 490 people
- Sponsor
- Daiichi Sankyo
HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+)…
- Trial name
- NCT06123494
- Testing
- SHR-A1811, Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Gastric Cancer
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients
This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.
- Trial name
- NCT01402401
- Testing
- AUY922, Trastuzumab
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Non-Small Cell Lung Cancer, HER2-positive Colorectal Cancer
- Trial name
- NCT05514717
- Testing
- XMT-2056
- Where
- 14 sites in United States
- Volunteers
- 57 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
HER 2 Positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
A Phase 1b/2 Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AUR103 Calcium in Patients With HER2-positive Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
The study will have a dose escalation part (Phase 1b) and a randomized part (Phase 2). In Phase 1b, patients diagnosed with advanced HER2 positive gastric/gastroesophageal adenocarcinoma will be enrolled in a 3 + 3 design dose…
- Trial name
- NCT07040059
- Testing
- AUR103 Calcium, Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)
- Where
- 8 sites in India
- Volunteers
- 2 people
- Sponsor
- Aurigene Discovery Technologies Limited
HER2-positive Gastric Cancer
JSKN003 Combined Treatment of HER2-positive Gastric Cancer
This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.
- Trial name
- NCT06998771
- Testing
- JSKN003, KN026, Capecitabine
- Volunteers
- 153 people
- Sponsor
- Shanghai JMT-Bio Inc.
HER2 Mutation-Related Tumors, HER2
A Phase 1/1b Study of IAM1363 in HER2 Cancers
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
- Conditions
- HER2 Mutation-Related Tumors, HER2, HER2-positive Breast Cancer, HER2 + Breast Cancer
- Trial name
- NCT06253871
- Testing
- IAM1363
- Where
- 53 sites in United States, France and 6 more
- Volunteers
- 383 people
- Sponsor
- Iambic Therapeutics, Inc
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab…
- Trial name
- NCT06764875
- Testing
- Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab
- Where
- 304 sites in United States, Argentina and 26 more
- Volunteers
- 840 people
- Sponsor
- AstraZeneca
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
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
- 253 sites in United States, Australia and 20 more
- Volunteers
- 500 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors, Advanced or Metastatic Gastric Cancer
A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG002 in patients with HER2-positive…
- Conditions
- Advanced Solid Tumors, Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Cancer
- Trial name
- NCT04492488
- Testing
- MRG002
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- Shanghai Miracogen Inc.
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Solid Tumor, Gastric Cancer
A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors
This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- NCT04511871
- Testing
- CCT303-406
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai PerHum Therapeutics Co., Ltd.
Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients…
- Trial name
- NCT04467515
- Testing
- CAM-H2
- Where
- 12 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Precirix
Solid Tumor, HER-2 Protein Overexpression
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting…
- Trial name
- NCT03680560
- Testing
- ACTR T Cell Product, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cogent Biosciences, Inc.
Locally Advanced Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer
A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal…
- Trial name
- NCT05141747
- Testing
- MRG002
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Miracogen Inc.
Gastric Cancer
Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer in East Asia
This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and…
- Trial name
- NCT05606094
- Where
- 31 sites in China, Hong Kong and 2 more
- Volunteers
- 450 people
- Sponsor
- Daiichi Sankyo Co., Ltd.