Clinical trials: HER-2 Gene Amplification
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in patients whose cancer has a genetic change called HER2 amplification.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT04439110
- Testing
- Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- National Cancer Institute (NCI)
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.
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
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Stomach Neoplasms, Neoplasms Metastasis
Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease are to be recruited in the study.
- Conditions
- Stomach Neoplasms, Neoplasms Metastasis, ERBB2 Gene Amplification
- Trial name
- NCT02004769
- Testing
- Trastuzumab, Docetaxel, Capecitabine
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Sun Yat-sen University
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.
Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult…
- Conditions
- Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression
- Trial name
- NCT07361562
- Testing
- CGT4255
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cogent Biosciences, Inc.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 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 GVV858 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
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Breast Cancer Female
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR).
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- Trial name
- NCT03137693
- Testing
- Standard of Care Schedule Variation: SABR, Breast-conserving Surgery
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Lung Cancer
Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression
The goal of this clinical trial is to learn ifDisitamab Vedotin in combination with tislelizumab and bevacizumab can treat in locally advanced or metastatic non-small cell lung cancer patients with HER2…
- Trial name
- NCT06749860
- Testing
- Disitamab Vedotin + tislelizumab + bevacizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Malignant Solid Neoplasm
Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)
This phase II MATCH treatment trial tests how well trastuzumab and pertuzumab work in treating patients with HER2-amplified non-breast, non-gastric/gastroesophageal junction, and non-colorectal cancers.
- Trial name
- NCT06136897
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Cancer Institute (NCI)
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
Urothelial Carcinoma
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra).
- Trial name
- NCT05911295
- Testing
- disitamab vedotin, pembrolizumab, gemcitabine
- Where
- 268 sites in United States, Argentina and 22 more
- Volunteers
- 412 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Colon Adenocarcinoma, ERBB2 Gene Amplification
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it…
- Conditions
- Colon Adenocarcinoma, ERBB2 Gene Amplification, Rectal Adenocarcinoma, Recurrent Colon Carcinoma
- Trial name
- NCT03365882
- Testing
- Cetuximab, Irinotecan Hydrochloride, Laboratory Biomarker Analysis
- Where
- 798 sites in United States, Puerto Rico
- Volunteers
- 240 people
- Sponsor
- SWOG Cancer Research Network
Gastric Adenocarcinoma, Esophageal Adenocarcinoma
Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas
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…
- Conditions
- Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Metastasis, HER-2 Gene Amplification
- Trial name
- NCT03783936
- Testing
- Oxaliplatin, Leucovorin, 5 fluorouracil
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ashwin Somasundaram
Breast Neoplasms, HER-2 Gene Amplification
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
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…
- Trial name
- EPTTCSM (NCT03979911)
- Where
- France
- Volunteers
- 63 people
- Sponsor
- University Hospital, Brest
HER-2 Protein Overexpression, HER-2 Gene Amplification
Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer.
- Trial name
- BIOs-Her (NCT04215159)
- Testing
- Trastuzumab biosimilar, Gemcitabine Hydrochloride, Irinotecan Hydrochloride
- Volunteers
- 42 people
- Sponsor
- Jin-Hee Ahn
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
Metastatic Breast Cancer
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer
This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer.
- Trial name
- HERLAP (NCT00842998)
- Testing
- Trastuzumab or Lapatinib
- Where
- 4 sites in Italy
- Volunteers
- 120 people
- Sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino