6 recruiting, 5 unknown, 4 completed, 2 active not recruiting. 12 Phase 2, 7 Phase 1, 1 Early Phase 1, 1 Phase 3.
Follow HER2 Gene Mutation: new trials by email Literature Review of HER2 Gene Mutation trials Research Report on HER2 Gene Mutation
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer PET imaging with ⁸⁹Zr-trastuzumab, Blood sampling for pharmacokinetics - Lung Cancer (NSCLC), HER2 Expression | Phase 1 | Recruiting | The Netherlands Cancer Institute | 20 | 2026-10-02 | 2026-10-20 |
| Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors BL-M17D1 - Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer | Phase 1 | Terminated | SystImmune Inc. | 3 | 2025-04-10 | 2026-09-22 |
| HEAT Trial (HER2 Antibody Therapy With Lutetium-177) 177Lu-RAD202 - HER2 Gene Mutation, Advanced Solid Tumors | Early Phase 1 | Recruiting | Radiopharm Theranostics, Ltd | 30 | 2025-02-12 | 2026-09-24 |
| Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer SOC plus trastuzumab and pembrolizumab - Biliary Tract Cancer, HER2 Gene Mutation | Phase 2 | Active not recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 24 | 2024-04-17 | 2026-03-27 |
| Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer Tumor samples will be tested for mutation status of KRAS, NRAS, BRAF, HER2 and MSI - Colorectal Cancer Metastatic, Brain Metastases, Adult | Recruiting | Blokhin's Russian Cancer Research Center | 30 | 2024-04-01 | 2026-10-05 | |
| A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer Pembrolizumab, Trastuzumab, Oxaliplatin - Esophageal Cancer, Gastric Adenocarcinoma | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 49 | 2024-02-01 | 2026-10-13 |
| To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer Injection of IAH0968 + CAPEOX, PLACEBO+CAPEOX - HER2 Gene Mutation | Phase 2 / Phase 3 | Unknown | SUNHO（China）BioPharmaceutical CO., Ltd. | 279 | 2023-05-12 | 2024-02-20 |
| Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma Disitamab Vedotin Plus Cadonilimab - Bile Duct Adenocarcinoma Non-Resectable, HER2 Gene Mutation | Phase 2 | Unknown | Zhejiang Cancer Hospital | 28 | 2023-05-01 | 2024-04-26 |
| IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors Injection of IAH0968+Gemcitabine+Cisplatin, Gemcitabine+Cisplatin - HER2 Gene Mutation | Phase 1 / Phase 2 | Unknown | SUNHO（China）BioPharmaceutical CO., Ltd. | 136 | 2023-04-25 | 2024-02-20 |
| ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine - HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer | Phase 1 | Active not recruiting | Enliven Therapeutics | 198 | 2023-03-20 | 2025-07-15 |
| Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors ORM-5029 - HER2-positive Breast Cancer, HER-2 Protein Overexpression | Phase 1 | Terminated | Orum Therapeutics USA, Inc. | 25 | 2022-10-03 | 2025-07-04 |
| Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD) - Gastric Cancer, Gastrointestinal Cancer | Phase 1 | Recruiting | Fox Chase Cancer Center | 18 | 2022-06-24 | 2026-09-21 |
| Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers Neratinib Maleate - Metastatic Cancer, HER2 Gene Mutation | Phase 2 | Completed | Korea University Guro Hospital | 42 | 2021-06-15 | 2025-03-18 |
| Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas Ado-trastuzumab (T) emtansine (T-DM1), Standard of Care Radiotherapy, Standard of Care Chemotherapy - Salivary Gland Cancer, HER2 Gene Mutation | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 37 | 2020-12-24 | 2026-04-13 |
| The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor Pyrotinib - Solid Tumor, HER2 Gene Mutation | Phase 2 | Unknown | Tianjin Medical University Second Hospital | 100 | 2019-12-01 | 2019-11-27 |
| Her2-positive Lung Cancer Treated With Dedicated Drug pertuzumab + trastuzumab + docetaxel - Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage III | Phase 2 | Completed | Intergroupe Francophone de Cancerologie Thoracique | 46 | 2019-05-17 | 2023-12-19 |
| Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene A166 - HER2-positive Breast Cancer, HER2 Gene Mutation | Phase 1 / Phase 2 | Completed | Klus Pharma Inc. | 49 | 2018-07-16 | 2023-08-03 |
| Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer Pyrotinib - Breast Cancer, HER2 Gene Mutation | Phase 2 | Unknown | Peking Union Medical College | 14 | 2018-02-20 | 2018-01-30 |
| Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Poziotinib - HER2 Gene Mutation, Adenocarcinoma Lung Stage IV | Phase 2 | Completed | Korean Association for the Study of Targeted Therapy | 6 | 2016-10-01 | 2018-05-24 |
Carcinoma, Non-Small-Cell Lung (4) · Breast Neoplasms (3) · Stomach Neoplasms (3) · Cholangiocarcinoma (2) · Lung Neoplasms (2) · Ovarian Neoplasms (2) · Salivary Gland Neoplasms (2) · Adenocarcinoma of Lung (1) · Bile Duct Neoplasms (1) · Biliary Tract Neoplasms (1) · Brain Neoplasms (1) · Carcinoma, Mucoepidermoid (1) · Carcinoma, Renal Cell (1) · Colonic Neoplasms (1) · Endometrial Neoplasms (1)
Neoplasms (13) · Neoplasms by Site (12) · Respiratory Tract Neoplasms (6) · Thoracic Neoplasms (6) · Digestive System Diseases (5) · Digestive System Neoplasms (5) · Lung Diseases (5) · Respiratory Tract Diseases (5) · Bronchial Neoplasms (4) · Carcinoma, Bronchogenic (4) · Gastrointestinal Diseases (4) · Lung Neoplasms (4) · Adenocarcinoma (3) · Breast Diseases (3) · Carcinoma (3)
Trastuzumab (3) · Ado-Trastuzumab Emtansine (2) · Docetaxel (2) · neratinib (2) · pembrolizumab (2) · pyrotinib (2) · Blood Specimen Collection (1) · Capecitabine (1) · Carboplatin (1) · Cisplatin (1) · Defecation (1) · Fluorouracil (1) · Genes, mos (1) · HM781-36B (1) · Maytansine (1)
SUNHO（China）BioPharmaceutical CO., Ltd. (2) · Blokhin's Russian Cancer Research Center (1) · Dana-Farber Cancer Institute (1) · Enliven Therapeutics (1) · Fox Chase Cancer Center (1) · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1) · Intergroupe Francophone de Cancerologie Thoracique (1) · Klus Pharma Inc. (1) · Korea University Guro Hospital (1) · Korean Association for the Study of Targeted Therapy (1) · Memorial Sloan Kettering Cancer Center (1) · Orum Therapeutics USA, Inc. (1) · Peking Union Medical College (1) · Radiopharm Theranostics, Ltd (1) · SystImmune Inc. (1)
United States (7) · China (5) · South Korea (3) · Australia (2) · France (2) · Germany (1) · Italy (1) · Netherlands (1) · Russia (1) · Spain (1) · Taiwan (1)
Alexey Tryakin, MD, professor (1) · Ali Bekyashev, MD, professor (1) · Anna Stroganova, MD (1) · Fei Ma (1) · Glenn J Hanna, MD (1) · Haitao Wang (1) · Jieer Ying (1) · Jordi Rodon Ahnert, MD, PhD (1) · Liu Tianshu, M.D. (1) · Namrata Vijavergia, MD (1) · Salah-Eddin Al-Batran, Prof. Dr. (1) · Sarah Tannenbaum, MD, MSc (1) · Yelena Janjigian, MD (1) · Zhou Jian, M.D. (1)