Clinical trials: Monoclonal Antibody
Psoriatic Arthritis
Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis
Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA).
- Trial name
- PATERA (NCT03598751)
- Testing
- BCD-085
- Where
- 3 sites in Belarus, Russia
- Volunteers
- 194 people
- Sponsor
- Biocad
Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma
BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
This is a Phase 2, multi-cohort study to investigate safety, PK, and preliminary anti-tumor activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as first-line treatment.
- Trial name
- NCT03469557
- Testing
- Tislelizumab, Cisplatin, 5-FU
- Where
- 6 sites in China
- Volunteers
- 30 people
- Sponsor
- BeiGene
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
Alzheimer's Tau Platform: Regimen A - AADvac1
The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early…
- Conditions
- Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease
- Trial name
- ATP (NCT07167966)
- Testing
- AADvac1, Donanemab
- Where
- 7 sites in United States
- Volunteers
- 450 people
- Sponsor
- Paul S. Aisen
Ovarian Cancer, Colorectal Cancer
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small…
- Conditions
- Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung, Prostate Cancer
- Trial name
- NCT00132522
- Testing
- EMD 273066
- Where
- 5 sites in United States, Switzerland
- Volunteers
- 45 people
- Sponsor
- EMD Serono
Rheumatoid Arthritis
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy…
- Trial name
- NCT00195702
- Testing
- Adalimumab
- Where
- 87 sites in United States, Canada
- Volunteers
- 619 people
- Sponsor
- Abbott
Urothelial Carcinoma, Renal Cell Carcinoma
A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.
The objective of this study is to assess the overall response rate, evaluate the antitumor activity, and characterize the safety and tolerability of BGB-A445 alone or in combination with tislelizumab in participants With Advanced…
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, Non-mucosal Melanoma
- Trial name
- NCT05661955
- Testing
- BGB-A445, Tislelizumab
- Where
- 18 sites in China
- Volunteers
- 113 people
- Sponsor
- BeiGene
HIV Antibodies
Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Background: The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same.
- Trial name
- VRC 609 (NCT03538626)
- Testing
- VRC-HIVMAB091-00-AB, rHuPH20
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multiple Myeloma
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen.
- Trial name
- NCT03984097
- Testing
- TAK-079, Lenalidomide, Dexamethasone
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Takeda
Ovarian Cancer
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells.
- Trial name
- NCT00072410
- Testing
- 90Y-hu3S193, 111In-hu3S193
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ludwig Institute for Cancer Research
Melanoma, Lung Cancer
Open-label, Uncontrolled, Non-Interventional, Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors (Anti-PD-1/Anti-PD-L1 Monoclonal Antibodies) Treatment for Solid Tumors
The recent approval of ICB treatments targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1/PD-L1) by the US Food and Drug Administration has offered an improved treatment chance for a variety of…
- Trial name
- NCT04860076
- Testing
- Pembrolizumab
- Where
- Belgium
- Volunteers
- 400 people
- Sponsor
- Asylia Diagnostics BV
Limited Stage Small Cell Lung Cancer
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of…
- Trial name
- NCT04952597
- Testing
- Ociperlimab, Tislelizumab, Concurrent Chemoradiotherapy
- Where
- 33 sites in United States, China and 1 more
- Volunteers
- 126 people
- Sponsor
- BeiGene
Lymphoma, Follicular, Lymphoma, Low-Grade
FCM Versus R-FCM Followed by R-Maintenance or Observation Only
The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy (R-FCM) versus FCM chemotherapy alone for remission induction and to asses the safety and…
- Conditions
- Lymphoma, Follicular, Lymphoma, Low-Grade, Lymphoma, Intermediate-Grade
- Trial name
- NCT00317096
- Testing
- FCM, R-FCM, rituximab maintenance
- Where
- Germany
- Volunteers
- 319 people
- Sponsor
- Ludwig-Maximilians - University of Munich
Rheumatoid Arthritis
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
- Trial name
- NCT00487825
- Testing
- Canakinumab (investigational), Methotrexate (MTX)
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 78 people
- Sponsor
- Novartis
HIV Infections
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected…
- Trial name
- NCT03387150
- Testing
- VRC07-523LS
- Where
- 7 sites in United States, Switzerland
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Safety and Efficacy
Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid.
- Trial name
- NCT05021276
- Testing
- Ruxolitinib
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Clostridium Tetanus
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
- Trial name
- NCT06360250
- Testing
- Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, Tetanus human immunoglobulin (HTIG), Adsorbed tetanus vaccine (TT)
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
Preclinical Alzheimer's Disease, Alzheimer Disease
Alzheimer's Tau Platform: Master Protocol
The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late…
- Conditions
- Preclinical Alzheimer's Disease, Alzheimer Disease, Prodromal Alzheimer's Disease
- Trial name
- ATP (NCT06957418)
- Testing
- AADvac1, Tau2
- Where
- 7 sites in United States
- Volunteers
- 900 people
- Sponsor
- Paul S. Aisen
Phase 1, Dengue
Safety Study of Dengushield in Healthy Adults
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.
- Trial name
- NCT03883620
- Testing
- Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous, Dengushield 7 mg/kg (Cohort 3) intravenous
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Carcinoma, Renal Cell, Melanoma
Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal antibody in previously treated patients with…
- Trial name
- NCT00356460
- Testing
- GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody, GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ ) Monoclonal Antibody
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Genzyme, a Sanofi Company
Neoplasms
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants…
- Trial name
- NCT03843359
- Testing
- GSK3745417, Dostarlimab
- Where
- 12 sites in United States, Australia and 6 more
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
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