Clinical trials: Trastuzumab
Metastatic Breast Cancer
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of…
- Trial name
- NCT03062007
- Testing
- BI-CON-02
- Where
- 6 sites in Russia
- Volunteers
- 6 people
- Sponsor
- Biointegrator LLC
Gastric Cancer
Safety and Efficacy of NK510 to Treat Gastric Cancer
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer.NK510 will be administered in combination with PD-1 blockade or monoclonal anti-HER2 antibody.
- Trial name
- NCT06098898
- Testing
- NK510, Tislelizumab，atezolizumab or Trastuzumab
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Advanced Breast Cancer, Metastatic Breast Cancer
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer.
- Trial name
- NCT04924699
- Testing
- MRG002, Trastuzumab Emtansine for Injection
- Where
- 19 sites in China
- Volunteers
- 350 people
- Sponsor
- Shanghai Miracogen Inc.
Metastatic Breast Cancer
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
- Trial name
- DB-08 (NCT04556773)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
Neoplasms, Breast
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain…
- Trial name
- NCT00263588
- Testing
- lapatinib
- Where
- 74 sites in United States, Australia and 15 more
- Volunteers
- 242 people
- Sponsor
- Novartis Pharmaceuticals
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
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.
Neoplasms, Breast
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given…
- Trial name
- Neo ALTTO (NCT00553358)
- Testing
- Lapatinib, Trastuzumab, Paclitaxel
- Where
- 121 sites in Argentina, Belgium and 22 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Adult
Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects…
- Trial name
- Zotatifin (NCT04092673)
- Testing
- eFT226, Sotorasib, Fulvestrant
- Where
- 14 sites in United States
- Volunteers
- 30 people
- Sponsor
- Effector Therapeutics
Breast Cancer, Gastric Cancer
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT05678205
- Testing
- AB-201, Cyclophosphamide, Fludarabine
- Where
- 2 sites in United States, South Korea
- Sponsor
- Artiva Biotherapeutics, Inc.
Breast Cancer, Solid Tumor
To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic…
- Trial name
- NCT03006172
- Testing
- Inavolisib, Fulvestrant, Letrozole
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 200 people
- Sponsor
- Genentech, Inc.
HER2-positive Breast Cancer, HER2-positive Carcinoma
Margetuximab Expanded Access Program
The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.
- Trial name
- NCT03133988
- Testing
- Margetuximab
- Sponsor
- TerSera Therapeutics LLC
Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or…
- Trial name
- NCT06271837
- Testing
- Trastuzumab deruxtecan, Bevacizumab
- Where
- 29 sites in China
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Healthy
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union).
- Trial name
- NCT01603264
- Testing
- PF-05280014, Herceptin
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Non-small Cell Lung Carcinoma
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
- Trial name
- NCT04042701
- Testing
- Trastuzumab deruxtecan (DS-8201a), Pembrolizumab
- Where
- 30 sites in United States, France and 2 more
- Volunteers
- 115 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Malignancies
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that…
- Trial name
- CERTIS1 (NCT05417594)
- Testing
- AZD9574, Temozolomide (TMZ), [11C]AZ1419 3391
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 695 people
- Sponsor
- AstraZeneca
Breast Cancer
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive…
- Trial name
- NCT02419742
- Testing
- Carboplatin, Cyclophosphamide, Docetaxel
- Where
- 6 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system…
- Trial name
- NCT07214766
- Testing
- Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Breast Cancer
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified.
- Trial name
- NCT01304797
- Testing
- MM-302 Monotherapy, MM-302 in combination with trastuzumab, MM-302 in combination with trastuzumab q3w
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Merrimack Pharmaceuticals