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
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.
Breast Cancer
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with…
- Trial name
- NCT07405801
- Testing
- Inavolisib, Ribociclib, Fulvestrant
- Where
- 58 sites in United States, Argentina and 10 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Advanced Cancer, Metastatic Cancer
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: Find the recommended dose of ART4215 that can be given safely to participants…
- Conditions
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- Trial name
- NCT04991480
- Testing
- ART4215, Talazoparib, Niraparib
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 93 people
- Sponsor
- Artios Pharma Ltd
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
Early Breast Cancer
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
- Trial name
- NCT03499353
- Testing
- TALAZOPARIB
- Where
- 97 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
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
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals 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.
Non Small Cell Lung Cancer
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
This study will evaluate the efficacy and safety of RC48-ADC for injection in subjects with advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation.
- Trial name
- NCT04311034
- Testing
- RC48
- Where
- China
- Volunteers
- 37 people
- Sponsor
- RemeGen Co., Ltd.
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.
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.
NSCLC
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2)…
- Trial name
- PINNACLE (NCT05378763)
- Testing
- Poziotinib, Docetaxel
- Where
- United States
- Volunteers
- 268 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Neoplasms
An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another…
- Trial name
- NCT00580112
- Testing
- Dexamethasone, Trabectedin
- Where
- 33 sites in United States, France and 2 more
- Volunteers
- 127 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
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
Adenocarcinoma (NOS), Anal Cancer
DESTINY-PANTUMOUR04
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease…
- Conditions
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- DP-04 (NCT07124000)
- Testing
- Trastuzumab deruxtecan
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05216432
- Testing
- RLY-2608, Fulvestrant, Palbociclib 125mg
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 930 people
- Sponsor
- Relay Therapeutics, Inc.
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