Clinical trials: HER-2 Positive Esophageal Cancer
Gastric Cancer
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with…
- Trial name
- HELOISE (NCT01450696)
- Testing
- Capecitabine, Cisplatin, Herceptin
- Where
- 117 sites in United States, Australia and 23 more
- Volunteers
- 296 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal…
- Trial name
- NCT01220934
- Where
- Germany
- Volunteers
- 443 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Gastrointestinal Tract
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2)…
- Trial name
- NCT00680901
- Testing
- Lapatinib, Capecitabine, Oxaliplatin
- Where
- 183 sites in United States, Argentina and 21 more
- Volunteers
- 545 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.
- Trial name
- NCT00447226
- Where
- 20 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
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
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo 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
- Spotlight (NCT03504397)
- Testing
- zolbetuximab, oxaliplatin, folinic acid
- Where
- 218 sites in United States, Australia and 18 more
- Volunteers
- 565 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases
To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.
- Trial name
- NCT06374888
- Testing
- Neratinib maleate in combination with capecitabine
- Volunteers
- 28 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
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.
Gastric Cancer, Esophagogastric Junction Cancer
A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal…
- Conditions
- Gastric Cancer, Esophagogastric Junction Cancer, Esophageal Adenocarcinoma
- Trial name
- NCT07818070
- Testing
- ONO-4578, Nivolumab, Oxaliplatin
- Volunteers
- 600 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Colorectal Carcinoma, Gastric Adenocarcinoma
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX).
- Conditions
- Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04430738
- Testing
- tucatinib, trastuzumab, oxaliplatin
- Where
- 27 sites in United States, Japan
- Volunteers
- 40 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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.
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth…
- Conditions
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer
- Trial name
- NCT07431281
- Testing
- Sonesitatug vedotin, Rilvegostomig, Nivolumab
- Where
- 314 sites in United States, Australia and 22 more
- Volunteers
- 2,130 people
- Sponsor
- AstraZeneca
Esophageal Cancer, Gastric Cancer
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in…
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT06500052
- Testing
- BL-M17D1
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
HER2-expressing Cancers
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety…
- Trial name
- NCT03821233
- Testing
- ZW49
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 112 people
- Sponsor
- Zymeworks BC Inc.
HER-2 Gene Amplification, Esophagus Cancer
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
- Conditions
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer
- Trial name
- NCT01774851
- Testing
- MM-111, Paclitaxel, Trastuzumab
- Where
- 21 sites in United States
- Volunteers
- 84 people
- Sponsor
- Merrimack Pharmaceuticals
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.
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
Esophageal Cancer, GastroEsophageal Cancer
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with…
- Conditions
- Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer
- Trial name
- ZOLA (NCT07780968)
- Testing
- Zanidatamab
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Jazz Pharmaceuticals
Gastric Neoplasms, Gastroesophageal Adenocarcinoma
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
- Conditions
- Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- HERIZON-GEA-01 (NCT05152147)
- Testing
- Zanidatamab, Tislelizumab, Trastuzumab
- Where
- 227 sites in Argentina, Australia and 31 more
- Volunteers
- 920 people
- Sponsor
- Jazz Pharmaceuticals
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.