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HER-2 Gene Amplification clinical trials

View clinical trials related to HER-2 Gene Amplification.

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NCT ID: NCT05511844 Recruiting - Clinical trials for HER2-positive Breast Cancer

Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors

Start date: October 3, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.

NCT ID: NCT05318339 Recruiting - Clinical trials for Carcinoma, Transitional Cell

A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma

Start date: March 10, 2022
Phase: Phase 2
Study type: Interventional

A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma.

NCT ID: NCT05170256 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients

HERES
Start date: February 4, 2022
Phase: Phase 2
Study type: Interventional

The study aims to determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with HER2 positive Esophageal squamous cell carcinoma (ESCC) determined by 6 months progression free survival (PFS) (RECIST 1.1).

NCT ID: NCT04660929 Active, not recruiting - Breast Cancer Clinical Trials

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Start date: February 2, 2021
Phase: Phase 1
Study type: Interventional

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

NCT ID: NCT04650451 Suspended - Solid Tumor, Adult Clinical Trials

Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

Start date: December 7, 2020
Phase: Phase 1
Study type: Interventional

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 previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.

NCT ID: NCT04215159 Not yet recruiting - Clinical trials for HER-2 Protein Overexpression

Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor

BIOs-Her
Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used after gaining official permission recently, clinical data for this use is still lacking, especially regarding experiences of combination with various cytotoxic chemotherapy agents. Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in patient's blood originated from a tumor is being developed and improved along with introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic testing. The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to investigate the association between ctDNA and clinical outcomes such as disease response, progression-free survival, and overall survival.

NCT ID: NCT04179656 Not yet recruiting - Solid Tumor Clinical Trials

The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor

Start date: December 2019
Phase: Phase 2
Study type: Interventional

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 staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive.

NCT ID: NCT03979911 Recruiting - Breast Neoplasms Clinical Trials

Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer

EPTTCSM
Start date: January 22, 2019
Phase:
Study type: Observational

This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

NCT ID: NCT03783936 Completed - Clinical trials for Gastric Adenocarcinoma

Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

The initial intent of the study was to be a multi-center single-arm open-label Simon's two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in metastatic HER2-amplified gastric and esophageal adenocarcinomas. Accrual will halt after completion of Stage I (enrollment of 18 patients). This decision is not due to safety issues. Subjects currently on treatment will continue until criteria as defined in the protocol is met.

NCT ID: NCT03630809 Terminated - Breast Cancer Clinical Trials

Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines. There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence. This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.