Clinical trials: HER2-positive Locally Advanced Unresectable
- Condition HER2-positive Locally Advanced Unresectable
- Funder type Industry (pharma, biotech, devices)
HER2-positive Solid Tumors
Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors
This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.
- Trial name
- NCT04521179
- Testing
- KN026 combination
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., 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.
HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
This study is a multicenter, open-label, phase II clinical study to explore the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2-positive gastric or…
- Trial name
- NCT06423885
- Testing
- BL-M07D1, PD-1 monoclonal antibody
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced or Metastatic Breast Cancer
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic…
- Trial name
- B-PRECISE-01 (NCT03767335)
- Testing
- MEN1611, Trastuzumab, Fulvestrant
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 62 people
- Sponsor
- Menarini Group
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.
Locally Advanced Unresectable or Metastatic Gastric Cancer, Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
Gastric/GEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health.
- Trial name
- NCT06177041
- Testing
- M108 monoclonal antibody, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 486 people
- Sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts…
- Trial name
- NCT06686394
- Testing
- Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 181 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic HER2 Positive Gastroesophageal Junction Cancer
CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Trial name
- NCT05207722
- Testing
- CYNK-101, Pembrolizumab, Trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Celularity Incorporated
Advanced or Metastatic Urothelium Cancer
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or…
- Trial name
- NCT05754853
- Testing
- MRG002, Docetaxel Injection, Paclitaxel Injection
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Shanghai Miracogen Inc.
HER2-positive Locally Advanced Unresectable, Metastatic Breast Cancer
A Study to Learn More About Tukysa Once it is Out in the Korean Market
The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in…
- Trial name
- NCT06873191
- Volunteers
- 600 people
- Sponsor
- Pfizer
HER2-positive Gastric Cancer
A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer
This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive…
- Trial name
- NCT07332533
- Testing
- KN026, Capecitabine, Enlonstobart
- Volunteers
- 490 people
- Sponsor
- Shanghai JMT-Bio Inc.
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
Locally Advanced Urothelial Cancer, Metastatic Urothelial Carcinoma
A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium 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 unresectable locally advanced or metastatic urothelium cancer.
- Trial name
- NCT04839510
- Testing
- MRG002
- Where
- 36 sites in China
- Volunteers
- 58 people
- Sponsor
- Shanghai Miracogen Inc.
HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic…
- Trial name
- NCT02658734
- Testing
- Trastuzumab emtansine
- Where
- 13 sites in India
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
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
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)
The goal of this study is to evaluate the efficacy and safety of tucatinib in combination with trastuzumab and capecitabine in participants with unresectable locally advanced or metastatic HER2+ breast cancer who have had prior…
- Trial name
- NCT04721977
- Testing
- Tucatinib, Trastuzumab, Capecitabine
- Where
- 28 sites in Japan, South Korea and 1 more
- Volunteers
- 66 people
- Sponsor
- Pfizer