Clinical trials: HER-2 Gene Amplification
Neoplasms, Breast
Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer
This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.
- Trial name
- NCT00356811
- Testing
- Lapatinib oral tablets, Paclitaxel infusion
- Where
- 13 sites in Latvia, Poland and 2 more
- Volunteers
- 57 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer
The purpose of this study is to determine if margetuximab is effective in the treatment of certain patients with relapsed or refractory advanced breast cancer.
- Trial name
- NCT01828021
- Testing
- Margetuximab
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- MacroGenics
Recurrent or Metastatic Breast Cancer
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
This was a prospective, single-center clinical study. The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and clinical response in patients with recurrent or…
- Trial name
- NCT03947736
- Testing
- cfDNA was detected by dPCR
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer
Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver…
- Trial name
- NCT00047255
- Testing
- trastuzumab, carboplatin, docetaxel
- Where
- United States
- Volunteers
- 263 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
Recurrent/Advanced Gastric Cancer
Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression
Clinical Indication : HER mutated or HER2 Amplification/Overexpression in Gastric Cancer, 2nd-line Trial Type : Interventional, Open label Treatment Groups : Single arm: Pembrolizumab 200 mg every 3 weeks (Q3W), neratinib at 240…
- Trial name
- NCT05512182
- Testing
- Chemotherapy
- Where
- South Korea
- Sponsor
- Yonsei University
HER-2 Gene Amplification
A Study of MM-111 in Combination With Multiple Treatments in Patients With HER2 Positive Cancer
This study is an open-label, dose-escalation study of MM-111 with five different combination treatments with the main goal of determining the safety of MM-111 with each combination.
- Trial name
- NCT01304784
- Testing
- Cisplatin, Capecitabine, Trastuzumab and MM-111, Lapatinib +/- Trastuzumab and MM-111, Paclitaxel, Trastuzumab and MM-111
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merrimack Pharmaceuticals
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
- Trial name
- NCT03804515
- Testing
- 14C-labeled poziotinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination.
- Trial name
- NCT01613950
- Testing
- AUY922, BYL719
- Where
- 9 sites in United States, Germany and 4 more
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast
Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.
- Trial name
- NCT00320385
- Testing
- Lapatinib, Trastuzumab
- Where
- 145 sites in United States, Austria and 11 more
- Volunteers
- 296 people
- Sponsor
- GlaxoSmithKline
HER2 Mutation-Related Tumors, HER2 Amplified Solid Tumors
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)
A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)
- Trial name
- NCT05041972
- Testing
- ARX788
- Where
- 2 sites in United States
- Sponsor
- Ambrx, Inc.
Advanced Solid Tumors, HR+ Breast Cancer
(VELA) Study of BLU-222 in Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
- Conditions
- Advanced Solid Tumors, HR+ Breast Cancer, CCNE1 Amplification, HER2-negative Breast Cancer
- Trial name
- NCT05252416
- Testing
- BLU-222, Carboplatin, Ribociclib
- Where
- 23 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Blueprint Medicines Corporation
Solid Tumor
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
- Trial name
- NCT05274191
- Testing
- Pyrotinib Maleate, standard regimen
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Zhongshan Hospital Xiamen University
Relapsed Breast Cancer, Neoplasms, Breast
Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer
This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or…
- Trial name
- NCT00479856
- Testing
- Lapatinib, Capecitabine, Docetaxel
- Where
- 28 sites in United States
- Volunteers
- 9 people
- Sponsor
- GlaxoSmithKline
Non Small Cell Lung Cancer
Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities
This is a phase II trial in patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 gene abnormalities （amplification or overexpression）with a performance status of 0 to1 who are planned to receive…
- Trial name
- NCT07630077
- Testing
- Trastuzumab Rezetecan, ivonescimab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sun Yat-sen University
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Melanoma, Stage II, HER2-positive
A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
- Conditions
- Melanoma, Stage II, HER2-positive, Advanced Melanoma
- Trial name
- NCT05135715
- Testing
- RC48-ADC
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
The goal of the retrospective phase of this study is to validate the specificity and the sensitivity of two Real-Time quantitative PCR based techniques in order to support the gold-standard approaches used to evaluate the HER2…
- Trial name
- CRANBERRY (NCT06813456)
- Where
- Italy
- Volunteers
- 234 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Solid Tumor, HER2 Gene Mutation
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
This is an open-label, Phase 2 study exploring the efficacy and safety of 马来酸Pyrotinib Maleate Tablets in patients with solid tumors with activating（harmful） HER2 mutations or with HER2 gene amplification or immunohistochemical…
- Conditions
- Solid Tumor, HER2 Gene Mutation, HER-2 Gene Amplification, HER-2 Protein Overexpression
- Trial name
- NCT04179656
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tianjin Medical University Second Hospital