Clinical trials: HER2 Mutation
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Neoplasms, Breast, Carcinoma of Breast
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
- Conditions
- Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation
- Trial name
- BRAVO (NCT01905592)
- Testing
- niraparib, Physician's choice
- Where
- 104 sites in United States, Belgium and 12 more
- Volunteers
- 216 people
- Sponsor
- Tesaro, Inc.
Advanced Breast Cancer
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast…
- Trial name
- NCT04524000
- Testing
- Alpelisib, Fulvestrant
- Where
- 15 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Trial name
- DESTINY-Lung01 (NCT03505710)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 181 people
- Sponsor
- Daiichi Sankyo
Disease Progression
Treatment Resistance Following Anti-cancer Therapies
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies. New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and…
- Trial name
- NCT04436120
- Testing
- De novo tumor tissue biopsy, Research blood draws
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors
A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.
- Trial name
- NCT06560138
- Testing
- SHR-4602
- Where
- 5 sites in Australia
- Sponsor
- Atridia Pty Ltd.
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
- Trial name
- NCT05048797
- Testing
- Trastuzumab Deruxtecan, Cisplatin, Carboplatin
- Where
- 130 sites in United States, Austria and 18 more
- Volunteers
- 454 people
- Sponsor
- AstraZeneca
Melanoma, Stage II, HER2-positive
A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
- Conditions
- Melanoma, Stage II, HER2-positive, Advanced Melanoma
- Trial name
- NCT05135715
- Testing
- RC48-ADC
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both 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
- NCT06360211
- Testing
- BAY2927088, Midazolam
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bayer
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants
Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body.
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06221475
- Testing
- BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion, [14C]-BAY2927088 oral solution
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bayer
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
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.
NSCLC, Breast Cancer
A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib
This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from…
- Trial name
- NCT03744715
- Testing
- Poziotinib
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Advanced Non-small Cell Lung Cancer, Cancer
Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human…
- Trial name
- NCT06761976
- Testing
- Sevabertinib
- Sponsor
- Bayer
Breast Cancer Metastatic
A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.
- Trial name
- NCT05420779
- Testing
- TSL-1502 capsules(low dose), TSL-1502 capsules(high dose), Investigator's choice of chemotherapy
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.