Clinical trials: HER2 Gene Mutation
Advanced Non-small Cell Lung Cancer, HER2 Mutation
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
- Trial name
- SOHO-02 (NCT06452277)
- Testing
- Sevabertinib, Pembrolizumab, Cisplatin
- Where
- 279 sites in United States, Argentina and 34 more
- Volunteers
- 444 people
- Sponsor
- Bayer
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.
Carcinoma, Non-Small-Cell Lung
Afatinib in NSCLC With HER2 Mutation
to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens
- Trial name
- NCT02597946
- Testing
- afatinib, paclitaxel
- Where
- 9 sites in China, Malaysia
- Volunteers
- 18 people
- Sponsor
- Boehringer Ingelheim
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 254 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
HER2 Mutation-Related Tumors, HER2
A Phase 1/1b Study of IAM1363 in HER2 Cancers
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
- Conditions
- HER2 Mutation-Related Tumors, HER2, HER2-positive Breast Cancer, HER2 + Breast Cancer
- Trial name
- NCT06253871
- Testing
- IAM1363
- Where
- 53 sites in United States, France and 6 more
- Volunteers
- 383 people
- Sponsor
- Iambic Therapeutics, Inc
Breast Cancer Metastatic, BRCA 1 Gene Mutation
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in…
- Conditions
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- OlympiAD (NCT02000622)
- Testing
- Olaparib, Physician's choice chemotherapy
- Where
- 171 sites in United States, Bulgaria and 17 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
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
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
HER2-negative Breast Cancer
Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite…
- Trial name
- NCT03575065
- Testing
- BGB-290
- Where
- 20 sites in China
- Volunteers
- 88 people
- Sponsor
- BeiGene
Advanced Solid Tumors, HER2 Mutation
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety…
- Trial name
- panSOHO (NCT06760819)
- Testing
- BAY2927088
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
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.
Non Small Cell Lung
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation.
- Trial name
- NCT02834936
- Testing
- pyrotinib
- Where
- 11 sites in China
- Volunteers
- 60 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumor
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.
- Trial name
- CVL009-C2001 (NCT06519110)
- Testing
- Neratinib tablets
- Volunteers
- 60 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
Breast Cancer
A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer
The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back.
- Trial name
- NCT06735742
- Where
- Japan
- Volunteers
- 3 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of…
- Trial name
- NCT03974022
- Testing
- Sunvozertinib
- Where
- 124 sites in United States, Argentina and 11 more
- Volunteers
- 315 people
- Sponsor
- Dizal Pharmaceuticals
Non-Small Cell Lung Cancer, NSCLC
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung…
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
- Trial name
- NCT06043817
- Testing
- STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D)
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 345 people
- Sponsor
- Pierre Fabre Medicament