Clinical trials: Trastuzumab
Oral Squamous Cell Carcinoma
A Prospective, Single-arm Phase II Clinical Trial of Tislelizumab Combined With Platinum Doublet Neoadjuvant Therapy to Improve Mandibular Preservation in Resectable Locally Advanced Oral Squamous Cell Carcinoma.
Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard…
- Trial name
- B2023-153 (NCT06130007)
- Testing
- Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Xuekui Liu
HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth…
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT02827877
- Testing
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Breast Cancer, Chemotherapeutic Agent Toxicity
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
RATIONALE: Gathering information over time from laboratory tests, imaging scans, and assessment tests may help doctors learn more about the side effects of chemotherapy and plan the best treatment.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Fatigue
- Trial name
- NCT00755313
- Testing
- trastuzumab, aromatase inhibition therapy, carboplatin
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HER2-positive Breast Cancer
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
- Trial name
- NCT06330012
- Testing
- GeoMx data analysis with clinical outcome
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
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
Breast Cancer, Neoplasm, Breast
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and…
- Conditions
- Breast Cancer, Neoplasm, Breast, Breast Diseases
- Trial name
- NCT03756064
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Zhejiang Cancer Hospital
Breast Neoplasm
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
- Trial name
- NCT03013881
- Testing
- UB-921, Herceptin
- Where
- Taiwan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- United BioPharma
Trastuzumab Cardiotoxicity, HER2-Positive Breast Cancer Survivors
Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors
This is for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function.
- Trial name
- NCT02615054
- Testing
- 2D Echocardiogram, Cardiopulmonary exercise testing and post-CPET cardiac function
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Metastatic Breast Cancer, Metastatic Gastric Cancer
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells.
- Trial name
- NCT05765357
- Testing
- Trastuzumab for injection, Herceptin
- Where
- China
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Breast Cancer, HER2-positive Breast Cancer
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Trial name
- NCT05019365
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Healthy
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
- Trial name
- NCT02075073
- Testing
- SB3, EU sourced Herceptin®, US sourced Herceptin®
- Where
- Germany
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Healthy Volunteers
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
This is a double-blind, two-arm, parallel-group, single-dose study.
- Trial name
- NCT02665637
- Testing
- Trastuzumab
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy Volunteer
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Trial name
- NCT02100917
- Testing
- DMB-3111, trastuzumab
- Where
- Japan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers
- Trial name
- NCT03912441
- Testing
- BCD-147
- Where
- Russia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biocad
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
Breast Cancer Female
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and…
- Trial name
- NCT06035679
- Testing
- Pyrotinib and Trastuzumab
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Youzhi Zhu
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Trial name
- NCT04670796
- Testing
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Volunteer
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers.
- Trial name
- NCT01344863
- Testing
- trastuzumab [Herceptin]
- Where
- 2 sites in New Zealand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche