Clinical trials: Trastuzumab
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
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 Early Breast Cancer
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical…
- Trial name
- PHranceSCa (NCT03674112)
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 40 sites in United States, Argentina and 15 more
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not…
- Trial name
- NCT07545044
- Testing
- JSKN003, Trastuzumab, Pertuzumab
- Volunteers
- 60 people
- Sponsor
- Shanghai JMT-Bio Inc.
Colorectal Cancer Metastatic, Advanced Colorectal Cancer
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
- Trial name
- NCT06589830
- Testing
- TL938 Capsules, Trastuzumab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Suzhou Teligene Ltd.
Breast Neoplasms
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Primary objective: Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin…
- Trial name
- NCT00021255
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 42 sites in United States, Argentina and 40 more
- Volunteers
- 3,222 people
- Sponsor
- Sanofi
Metastatic Breast Cancer
Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).
- Trial name
- NCT00303108
- Testing
- Pegylated liposomal doxorubicin, Carboplatin, trastuzumab
- Where
- 57 sites in United States
- Volunteers
- 136 people
- Sponsor
- US Oncology Research
Urothelial Carcinoma
A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic urothelial cancer.
- Trial name
- NCT03809013
- Testing
- RC48-ADC
- Where
- 8 sites in China
- Volunteers
- 64 people
- Sponsor
- RemeGen 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
Neoplasms
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing…
- Trial name
- NCT02721641
- Testing
- Herceptin
- Where
- 41 sites in Australia, Belgium and 15 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
HER2-positive Advanced Breast Cancer
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
- Trial name
- NCT04185649
- Testing
- BAT8001 for injection, Lapatinib, Capecitabine
- Where
- 51 sites in China
- Volunteers
- 410 people
- Sponsor
- Bio-Thera Solutions
Healthy Male Participants
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
- Trial name
- NCT07299955
- Testing
- Bmab3000, Herceptin Hylecta®
- Where
- New Zealand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK PLC
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast…
- Trial name
- NCT02144012
- Testing
- Trastuzumab, Trastuzumab Emtansine, Docetaxel
- Where
- 8 sites in Malaysia, South Korea and 2 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Urinary Bladder Neoplasms, Neoplasm Metastasis
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
- Trial name
- FORAGER-1 (NCT05614739)
- Testing
- Vepugratinib, Pembrolizumab, enfortumab vedotin
- Where
- 83 sites in United States, Australia and 12 more
- Volunteers
- 677 people
- Sponsor
- Eli Lilly and Company
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent…
- Trial name
- NCT07495930
- Testing
- HLX319, EU-Phesgo
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
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.
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1…
- Trial name
- NCT01120561
- Testing
- trastuzumab-MCC-DM1
- Where
- 15 sites in United States
- Sponsor
- Genentech, Inc.