Clinical trials: ERBB2 Gene Amplification
HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses.
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
- Trial name
- HER2 (NCT05650879)
- Testing
- ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 198 people
- Sponsor
- Enliven Therapeutics
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
Urothelial Carcinoma
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.
- Trial name
- NCT04879329
- Testing
- disitamab vedotin, pembrolizumab
- Where
- 221 sites in United States, Argentina and 10 more
- Volunteers
- 372 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
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
Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728.
- Trial name
- NCT03410927
- Testing
- TAS0728
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Taiho Oncology, Inc.
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.
Breast Cancer
Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections
The purpose of the study is the identification of amplification level in human breast tissue. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of Her2…
- Trial name
- Her2F test (NCT01066507)
- Where
- 3 sites in United States, Israel
- Volunteers
- 126 people
- Sponsor
- Applied Spectral Imaging Ltd.
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
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
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
Neoplasms
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.
- Trial name
- NCT00748709
- Testing
- BIBW 2992 (Afatinib)
- Where
- 15 sites in United States, Taiwan
- Volunteers
- 20 people
- Sponsor
- Boehringer Ingelheim
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
Advanced Non-small Cell Lung Cancer
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification…
- Trial name
- NCT04818333
- Testing
- SHR-A1811
- Where
- China
- Volunteers
- 157 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2 Expression / Amplification in Patients With Biliary Tract Cancer
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic…
- Trial name
- NCT06413745
- Testing
- SHR-A1811
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab…
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2 Positive Solid Tumors, HER2 Amplification
- Trial name
- NCT06328738
- Testing
- ELVN-002, Trastuzumab, 5-Fluorouracil
- Where
- 31 sites in United States, Belgium and 5 more
- Volunteers
- 275 people
- Sponsor
- Enliven Therapeutics
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
NSCLC, SCLC
Study of Oral MRT-2359 in Selected Cancer Patients
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer…
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL
- Trial name
- NCT05546268
- Testing
- Oral MRT-2359
- Where
- 17 sites in United States
- Volunteers
- 174 people
- Sponsor
- Monte Rosa Therapeutics, Inc
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
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.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.