Clinical trials: HER2 + Gastric Cancer
Gastric Cancer
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line…
- Trial name
- JACOB (NCT01774786)
- Testing
- 5-Fluorouracil, Capecitabine, Cisplatin
- Where
- 172 sites in United States, Australia and 30 more
- Volunteers
- 780 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer, Cancer of Stomach
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
This is a Phase 2, signal generating, open-label, 2-Arm, non-randomized study, in patients with metastatic HER2/neu over-expressing gastric cancer or gastroesophageal adenocarcinomas.
- Conditions
- Gastric Cancer, Cancer of Stomach, Gastric Adenocarcinoma, Stomach Cancer
- Trial name
- nextHERIZON (NCT05311176)
- Testing
- IMU-131, Ramucirumab plus Paclitaxel, Pembrolizumab
- Where
- 7 sites in Australia, Taiwan
- Volunteers
- 7 people
- Sponsor
- Imugene Limited
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
Gastric Cancer
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy…
- Trial name
- NCT06256328
- Testing
- ONO-4578, Oxaliplatin, Capecitabine
- Where
- 63 sites in Japan, South Korea and 1 more
- Volunteers
- 226 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
HER-2 Gene Amplification, HER2-positive Gastric Cancer
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with…
- Conditions
- HER-2 Gene Amplification, HER2-positive Gastric Cancer, HER2-positive Breast Cancer, HER-2 Protein Overexpression
- Trial name
- NCT04650451
- Testing
- chimeric antigen receptor (CAR) T cell therapy
- Where
- 7 sites in United States
- Volunteers
- 220 people
- Sponsor
- Bellicum Pharmaceuticals
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for…
- Trial name
- NCT03929666
- Testing
- ZW25 (Zanidatamab), Capecitabine, Cisplatin
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 74 people
- Sponsor
- Jazz Pharmaceuticals
Breast Cancer, Gastric Cancer
IKS014 in Advanced Solid Tumors That Express HER2
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- Trial name
- NCT05872295
- Testing
- IKS014
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 165 people
- Sponsor
- Iksuda Therapeutics Ltd.
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.
HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy…
- Trial name
- NCT05671822
- Testing
- SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine, SHR-A181, SHR-1701, and capecitabine
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Stomach Cancer
KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together.
- Trial name
- NCT05427383
- Testing
- KN026/Placbo Injection, Paclitaxel Injection, Docetaxel Injection
- Where
- China
- Volunteers
- 286 people
- Sponsor
- Shanghai JMT-Bio Inc.
HER2 Positive Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer
TAC T-cells for the Treatment of HER2-positive Solid Tumors
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).
- Trial name
- TACTIC-2 (NCT04727151)
- Testing
- TAC01-HER2, TAC01-HER2 plus pembrolizumab
- Where
- 11 sites in United States, Canada
- Volunteers
- 28 people
- Sponsor
- Triumvira Immunologics, Inc.
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
- Trial name
- NCT04014075
- Testing
- Trastuzumab deruxtecan
- Where
- 37 sites in United States, Belgium and 3 more
- Volunteers
- 79 people
- Sponsor
- Daiichi Sankyo
Breast Cancer, Gastric/Gastroesophageal Junction Cancer
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation.
- Trial name
- NCT03847168
- Testing
- KN026
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.
- Trial name
- NCT03556345
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 127 people
- Sponsor
- RemeGen Co., Ltd.
Melanoma, Renal Cell Carcinoma
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D.
- Conditions
- Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma
- Trial name
- PIVOT-02 (NCT02983045)
- Testing
- Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 557 people
- Sponsor
- Nektar Therapeutics
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.
- Trial name
- DPT02 (NCT04482309)
- Testing
- Trastuzumab deruxtecan
- Where
- 89 sites in United States, Australia and 15 more
- Volunteers
- 477 people
- Sponsor
- AstraZeneca
HER2-positive Solid Tumors, HER2-positive Breast Cancer
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
- Conditions
- HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Gastroesophageal Cancer
- Trial name
- NCT04278144
- Testing
- BDC-1001, Nivolumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 175 people
- Sponsor
- Bolt Biotherapeutics, Inc.
Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ.
- Trial name
- NCT06773312
- Testing
- BC001+Sintilimab+XELOX
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.