Clinical trials: Pertuzumab
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Male Volunteers
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety…
- Trial name
- NCT04411550
- Testing
- HLX11, CN-Perjeta(Pertuzumab), EU-Perjeta(Pertuzumab)
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection
To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects
- Trial name
- NCT05323981
- Testing
- HS627(210mg/7ml), HS627(420mg/14ml), Perjeta
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Healthy Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Comparative Study of QL1209 and Perjeta® in Healthy Male Participants
The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male…
- Trial name
- NCT07861139
- Testing
- QL1209, US-Perjeta®
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult…
- Trial name
- NCT07776132
- Testing
- HLX29, HLX11
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer, Adjuvant Therapy
Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor…
- Trial name
- NCT05292742
- Testing
- Pyrotinib+Trastuzumab+Capecitabine, Trastuzumab+Pertuzumab/Trastuzumab
- Where
- China
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Fujian Medical University Union Hospital
Healthy Volunteers
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate…
- Trial name
- NCT04820439
- Testing
- recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627), Perjeta ®
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy Men
Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man
PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men.
- Trial name
- NCT05825781
- Testing
- Pertuzumab, Perjeta®
- Where
- Russia
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Mabscale, LLC
Breast Cancer
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European…
- Trial name
- NCT05471648
- Testing
- 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection, Perjeta (US origin) 420 mg in 14 mL Injection
- Where
- Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- EirGenix, Inc.