Clinical trials: HER-2 Gene Amplification
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.
Sarcoma, Castrate Resistant Prostate Cancer
A Study of PRT2527 in Participants With Advanced Solid Tumors
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors.
- Conditions
- Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05159518
- Testing
- PRT2527
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prelude Therapeutics Incorporated
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.
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
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
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
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
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
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.
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma 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.
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
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 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.
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