5 unknown, 4 terminated, 3 active not recruiting, 3 recruiting. 11 Phase 1, 11 Phase 2.
Follow HER-2 Protein Overexpression: new trials by email Literature Review of HER-2 Protein Overexpression trials Research Report on HER-2 Protein Overexpression
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 |
|---|---|---|---|---|---|---|
| A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors Zanidatamab - Breast Cancer, Gastric Cancer | Phase 2 | Recruiting | Jazz Pharmaceuticals | 200 | 2025-01-14 | 2026-07-10 |
| Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer Disitamab vedotin, Bacillus Calmette Guerin Vaccine - Non-muscle Invasive Bladder Cancer, HER-2 Protein Overexpression | Phase 2 | Active not recruiting | Fudan University | 20 | 2023-12-18 | 2026-07-20 |
| DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC RC48+PD-1+platinum-based - Esophageal Squamous Carcinoma, HER-2 Protein Overexpression | Phase 1 / Phase 2 | Unknown | Changhai Hospital | 20 | 2023-09-30 | 2023-09-26 |
| Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction Nivolumab, Trastuzumab deruxtecan - Esophageal Adenocarcinoma, Esophageal Cancer | Phase 2 | Active not recruiting | Brown University | 1 | 2023-07-14 | 2026-04-21 |
| Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations Axitinib - Breast Cancer, Ovarian Cancer | Phase 1 | Completed | Lynkcell Europe | 10 | 2023-07-11 | 2024-12-30 |
| PRE-ISPY Phase I/II Oncology Platform Program ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab - HER2-positive Breast Cancer, Metastatic Cancer | Phase 1 / Phase 2 | Recruiting | QuantumLeap Healthcare Collaborative | 280 | 2023-02-15 | 2026-09-30 |
| 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 |
| Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients Trastuzumab - Esophageal Squamous Cell Carcinoma, HER-2 Protein Overexpression | Phase 2 | Unknown | Morten Mau-Sørensen | 24 | 2022-02-04 | 2022-08-12 |
| HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma T cells or CAR T cells, Pembrolizumab Injectable Product, Nivolumab Injectable Product - Sarcoma, HER-2 Protein Overexpression | Phase 1 | Recruiting | Baylor College of Medicine | 25 | 2021-12-07 | 2026-01-22 |
| ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer Vic-trastuzumab duocarmazine (SYD985) + paclitaxel - HER2-positive Breast Cancer, HER2 Low | Phase 1 | Withdrawn | QuantumLeap Healthcare Collaborative | 2021-07-28 | 2023-11-18 | |
| Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers SNK01, Trastuzumab, Cetuximab - Advanced Solid Tumor, Metastatic Cancer | Phase 1 / Phase 2 | Withdrawn | NKGen Biotech, Inc. | 2021-03-01 | 2021-05-12 | |
| CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors CT-0508, Pembrolizumab - HER2-positive, Adenocarcinoma | Phase 1 | Unknown | Carisma Therapeutics Inc | 48 | 2021-02-02 | 2024-12-18 |
| Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors chimeric antigen receptor (CAR) T cell therapy - HER-2 Gene Amplification, HER2-positive Gastric Cancer | Phase 1 | Suspended | Bellicum Pharmaceuticals | 220 | 2020-12-07 | 2023-04-20 |
| Testing a New Imaging Agent to Identify Cancer 89Zr-ss-pertuzumab PET/CT - HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression | Phase 1 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 60 | 2020-11-30 | 2026-07-13 |
| Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor Trastuzumab biosimilar, Gemcitabine Hydrochloride, Irinotecan Hydrochloride - HER-2 Protein Overexpression, HER-2 Gene Amplification | Phase 2 | Unknown | Jin-Hee Ahn | 42 | 2019-12-30 | 2020-01-02 |
| 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 |
| Trastuzumab in HER2-positive Biliary Tract Cancer Trastuzumab - Cholangiocarcinoma, Biliary Tract Cancer | Phase 2 | Completed | Changhoon Yoo | 4 | 2019-06-01 | 2021-01-05 |
| Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers ACTR T Cell Product, Trastuzumab - Solid Tumor, HER-2 Protein Overexpression | Phase 1 | Terminated | Cogent Biosciences, Inc. | 6 | 2019-03-13 | 2020-03-31 |
| Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1 HER2 DC1 Vaccine - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Terminated | H. Lee Moffitt Cancer Center and Research Institute | 16 | 2019-01-10 | 2022-04-25 |
| Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product ACTR T Cell Product - B Cell Lymphomas, Multiple Myeloma | Terminated | Cogent Biosciences, Inc. | 22 | 2016-10-01 | 2021-10-11 |
Breast Neoplasms (9) · Ovarian Neoplasms (5) · Stomach Neoplasms (5) · Colorectal Neoplasms (4) · Endometrial Neoplasms (4) · Neoplasm Metastasis (4) · Carcinoma, Non-Small-Cell Lung (3) · Esophageal Neoplasms (3) · Pancreatic Neoplasms (3) · Triple Negative Breast Neoplasms (3) · Urinary Bladder Neoplasms (3) · Adenocarcinoma (2) · Biliary Tract Neoplasms (2) · Carcinoma, Transitional Cell (2) · Neoplasms (2)
Neoplasms (13) · Neoplasms by Site (13) · Neoplasms by Histologic Type (10) · Breast Diseases (9) · Digestive System Diseases (9) · Digestive System Neoplasms (9) · Skin Diseases (9) · Skin and Connective Tissue Diseases (9) · Carcinoma (8) · Gastrointestinal Diseases (8) · Gastrointestinal Neoplasms (8) · Neoplasms, Glandular and Epithelial (8) · Female Urogenital Diseases (6) · Female Urogenital Diseases and Pregnancy Complications (6) · Urogenital Diseases (6)
Trastuzumab (4) · zanidatamab (2) · ALX148 (1) · Automobiles (1) · Axitinib (1) · BCG Vaccine (1) · Cetuximab (1) · Gemcitabine (1) · Immune Checkpoint Inhibitors (1) · Immunotherapy, Adoptive (1) · Irinotecan (1) · Nivolumab (1) · Paclitaxel (1) · Receptors, Chimeric Antigen (1) · Vaccines (1)
Cogent Biosciences, Inc. (2) · QuantumLeap Healthcare Collaborative (2) · Baylor College of Medicine (1) · Bellicum Pharmaceuticals (1) · Brown University (1) · Carisma Therapeutics Inc (1) · Changhai Hospital (1) · Changhoon Yoo (1) · Fudan University (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Jazz Pharmaceuticals (1) · Jin-Hee Ahn (1) · Lynkcell Europe (1) · Memorial Sloan Kettering Cancer Center (1) · Morten Mau-Sørensen (1)
United States (12) · China (2) · South Korea (2) · Denmark (1) · Spain (1) · Ukraine (1)
Paula R Pohlmann, MD, MSc, PhD (2) · Anthony Elias, MD (1) · Changhoon Yoo, MD (1) · Dingwei Ye (1) · Glen Weiss, MD (1) · Haitao Wang (1) · Howard Safran, MD (1) · Jeanett Wetzel (1) · Jessica Sachs, MD (1) · Lene Baeksgaard, MD PhD (1) · Manish A Shah, MD (1) · Meenakshi Hegde, MD (1) · Nabil Ahmed, MD (1) · Paul Y. Song, MD (1) · Ricardo Costa, M.D. (1)
PMID 36441083, PMID 36449446, PMID 38272704, PMID 39726590, PMID 39920391
R01CA276684 (1)