Clinical trials: HER2 Mutation
Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Trial name
- AGATHA (NCT07619066)
- Testing
- Zongertinib (BI 1810631), Fulvestrant
- Volunteers
- 25 people
- Sponsor
- MedSIR
Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations
- Trial name
- NCT05364073
- Testing
- Furmonertinib
- Where
- 42 sites in United States, Australia and 9 more
- Volunteers
- 160 people
- Sponsor
- ArriVent BioPharma, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT05554354
- Testing
- Binimetinib, Biopsy Procedure, Biospecimen Collection
- Where
- 196 sites in United States, Puerto Rico
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor…
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06329895
- Testing
- BAY2927088, Dabigatran etexilate, Rosuvastatin
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bayer
HER2 Gene Mutation
IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors
The study aims to evaluate the efficacy and safety of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma.
- Trial name
- NCT05991518
- Testing
- Injection of IAH0968+Gemcitabine+Cisplatin, Gemcitabine+Cisplatin
- Where
- China
- Volunteers
- 136 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Breast Cancer
Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more…
- Trial name
- NCT00898898
- Testing
- diagnostic laboratory biomarker analysis
- Volunteers
- 2,837 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer
This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone…
- Trial name
- NCT07784036
- Testing
- JYP0035 plus Fulvestrant
- Volunteers
- 171 people
- Sponsor
- Chengdu JOYO pharma Co., Ltd.
Breast Cancer
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced…
- Trial name
- NCT07543250
- Testing
- Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i
- Volunteers
- 100 people
- Sponsor
- xuliang
ESR1 Gene Mutation, Advanced Breast Cancer
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination…
- Conditions
- ESR1 Gene Mutation, Advanced Breast Cancer, Safety
- Trial name
- NCT06544577
- Testing
- ELacestrant
- Where
- China
- Volunteers
- 350 people
- Sponsor
- SciClone Pharmaceuticals
ESR1 Gene Mutation, Advanced Breast Cancer
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.
- Trial name
- NCT06548919
- Testing
- Endocrine therapy, Chemotherapy Prednisone
- Where
- China
- Volunteers
- 450 people
- Sponsor
- SciClone Pharmaceuticals
Metastatic Cancer, HER2 Gene Mutation
Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial Study drug : neratinib + herzuma (trastuzumab biosimilar)
- Trial name
- NCT06083662
- Testing
- Neratinib Maleate
- Where
- South Korea
- Volunteers
- 42 people
- Sponsor
- Korea University Guro Hospital
Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA…
- Trial name
- NCT04296370
- Testing
- Fluzoparib; Apatinib, Fluzoparib, Physician's choice chemotherapy
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
MSI-H Colorectal Cancer, Melanoma
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors.
- Conditions
- MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma, Mesothelioma
- Trial name
- ACROPOLI (NCT04802876)
- Testing
- Spartalizumab, Tislelizumab
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- SOLTI Breast Cancer Research Group
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
This phase II MATCH treatment trial identifies the effects of afatinib in patients whose cancer has genetic changes called HER2 mutations.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT04439136
- Testing
- Afatinib Dimaleate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC
The study consists of a screening period of 28 days, a treatment period. Local or central testing of PIK3CA mutation in blood or tumor tissue must be performed using an approved polymerase chain reaction (PCR)-based or next…
- Trial name
- NCT07245797
- Testing
- fixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib.
- Volunteers
- 164 people
- Sponsor
- Zhimin Shao
Metastatic Breast Cancer
A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents.
- Trial name
- NCT02544997
- Testing
- Poziotinib
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- Samsung Medical Center
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
Breast Cancer, HER2 Gene Mutation
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
- Trial name
- NCT03412383
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Peking Union Medical College
Advanced Non-Small-Cell Lung Cancer
Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer
HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced…
- Trial name
- NCT05435274
- Testing
- HS-10376
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.