Clinical trials: HER2-positive Solid Tumors
Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive, HER2/Neu Positive, Postmenopausal
- Trial name
- NCT02152943
- Testing
- Everolimus, Laboratory Biomarker Analysis, Letrozole
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
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
Advanced Solid Tumor
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced…
- Trial name
- NCT06241456
- Testing
- FT825, Fludarabine, Cyclophosphamide
- Where
- 14 sites in United States
- Volunteers
- 351 people
- Sponsor
- Fate Therapeutics
Breast Cancer
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of…
- Trial name
- NCT00741260
- Testing
- Neratinib, Capecitabine
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 105 people
- Sponsor
- Puma Biotechnology, Inc.
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
NSCLC, SCLC
Study of Oral MRT-2359 in Selected Cancer Patients
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer…
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL
- Trial name
- NCT05546268
- Testing
- Oral MRT-2359
- Where
- 17 sites in United States
- Volunteers
- 174 people
- Sponsor
- Monte Rosa Therapeutics, Inc
Advanced Solid Tumors
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors.
- Trial name
- HF50 (NCT06822998)
- Testing
- HF50
- Where
- China
- Volunteers
- 10 people
- Sponsor
- HighField Biopharmaceuticals Corporation
Metastatic Breast Cancer, HER2-positive Breast Cancer
HER-2 B Cell Peptide Vaccine
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an…
- Conditions
- Metastatic Breast Cancer, HER2-positive Breast Cancer, EGFR Overexpression, Metastatic Esophageal Carcinoma
- Trial name
- NCT06414733
- Testing
- Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 51
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Pravin T.P Kaumaya
HER2 Gene Mutation, Advanced Solid Tumors
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
- Trial name
- RAD202 (NCT06824155)
- Testing
- 177Lu-RAD202
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in HER2-Positive Solid Tumors
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03330561
- Testing
- PRS-343
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Male Breast Cancer
Akt Inhibitor MK2206 in Combination With Lapatinib Ditosylate in Patients With Advanced or Metastatic Solid Tumors or Breast Cancer
This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 and lapatinib ditosylate in treating patients with solid tumors or breast cancer that has spread to other places in the body.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer
- Trial name
- NCT01245205
- Testing
- Akt inhibitor MK2206, lapatinib ditosylate, pharmacological study
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Advanced Malignant Solid Tumors
Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
- Trial name
- NCT06658951
- Testing
- Anti-HER2 CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- UTC Therapeutics Inc.
Advanced Solid Tumor, Metastatic Breast Cancer
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination…
- Trial name
- NCT04872166
- Testing
- BTX-A51
- Where
- 6 sites in United States
- Volunteers
- 112 people
- Sponsor
- Edgewood Oncology Inc.
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
Solid Tumors That Overexpress HER2 (HER2 Positive)
Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)
To evaluate the safety, tolerability, dose limiting toxicity (DLT), and maximum tolerated dose (MTD), of FS102(BMS-986186) when administered intravenously (IV) to subjects with relapsed or refractory solid tumors that overexpress…
- Trial name
- NCT02286219
- Testing
- FS102
- Where
- 6 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Bristol-Myers Squibb
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.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Non-Small Cell Lung Cancer, HER2-positive Colorectal Cancer
- Trial name
- NCT05514717
- Testing
- XMT-2056
- Where
- 14 sites in United States
- Volunteers
- 57 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Peritoneal Carcinoma Metastatic, Pleural Effusion, Malignant
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties.
- Conditions
- Peritoneal Carcinoma Metastatic, Pleural Effusion, Malignant, HER2 Positive Malignancies
- Trial name
- NCT04684459
- Testing
- Dual-targeting HER2 and PD-L1 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Sichuan University