Clinical trials: Monoclonal Antibody
Rheumatoid Arthritis
First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts
This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a…
- Trial name
- NCT05576012
- Testing
- SOL-116
- Where
- 2 sites in Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Lipum AB
Systemic Lupus Erythematosus
Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
- Trial name
- NCT00660881
- Testing
- Epratuzumab
- Where
- 42 sites in United States, Belgium and 9 more
- Volunteers
- 210 people
- Sponsor
- UCB Pharma
Acute Myocardial Infarction (AMI)
Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients
The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI).
- Trial name
- IMPROVE-AMI (NCT06683131)
- Testing
- Tafolecimab
- Where
- 13 sites in China
- Volunteers
- 1,160 people
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
Cancer, Neoplasm Metastasis
Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
- Trial name
- NCT00492830
- Testing
- TRC093 recombinant humanized IgG1k monoclonal antibody
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Multiple Myeloma and Plasma Cell Neoplasm
High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- AntiCD-66 (NCT00637767)
- Testing
- melphalan, autologous hematopoietic stem cell transplantation, yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
- Where
- 3 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- University of Southampton
Solid Tumor
Pharmacokinetics and Tolerancebility Studies of Gentuximab Injection in the Treatment ofPatients With Late Recurrence of Metastatic Solid Tumors in China
The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab Injection in patients with late recurrence of…
- Trial name
- NCT03313219
- Testing
- Gentuximab Injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Gastric Cancer
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
This is a prospective, single-center, randomized controlled, phase II clinical trial. The study aims to enroll 48 patients with resectable, locally advanced gastroesophageal junction adenocarcinoma who have not received any…
- Trial name
- NCT07277439
- Testing
- Radiochemoimmunotherapy, Immunomodulation
- Where
- China
- Volunteers
- 48 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Plasma Cell Myeloma
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and…
- Trial name
- IMROZ (NCT03319667)
- Testing
- Isatuximab SAR650984, Bortezomib, Lenalidomide
- Where
- 104 sites in United States, Australia and 19 more
- Volunteers
- 475 people
- Sponsor
- Sanofi
Non Small Cell Lung Cancer
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy…
- Trial name
- INSPIRE (NCT00982111)
- Testing
- Pemetrexed, Cisplatin, Necitumumab
- Where
- 101 sites in United States, Australia and 18 more
- Volunteers
- 633 people
- Sponsor
- Eli Lilly and Company
Psoriasis
AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy.
- Trial name
- NCT00443326
- Testing
- AMG 714
- Volunteers
- 22 people
- Sponsor
- Amgen
Nephrotic Syndrome Steroid-Dependent
Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome. This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in…
- Trial name
- NCT04402580
- Testing
- Rituximab Biosimilar, Mycophenolate Mofetil
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Giannina Gaslini
Healthy
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used…
- Trial name
- NCT02912247
- Testing
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Myeloma Multiple
A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)
The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple…
- Trial name
- AMMADINA (NCT07742215)
- Testing
- BCD-248 + daratumumab, Daratumumab + pomalidomide + dexamethasone
- Where
- 16 sites in Belarus, Russia
- Volunteers
- 390 people
- Sponsor
- Biocad
Systemic Sclerosis-Associated PAH
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis)…
- Trial name
- NCT01086540
- Testing
- Rituximab, CMRI, prednisone
- Where
- 17 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
CANCER, NOS
Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor
To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with ipilimumab in subjects with select advanced…
- Trial name
- NCT01750580
- Testing
- Lirilumab, Ipilimumab
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Bristol-Myers Squibb
Recurrent Adult Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia
The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML.
- Trial name
- ARMY (NCT02353143)
- Testing
- MEN1112
- Where
- 29 sites in Belgium, France and 3 more
- Volunteers
- 71 people
- Sponsor
- Menarini Group
Advanced Cancer, Melanoma
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced…
- Conditions
- Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
- Trial name
- NCT02658890
- Testing
- BMS-986205, Nivolumab, Ipilimumab
- Where
- 47 sites in United States, Australia and 9 more
- Volunteers
- 627 people
- Sponsor
- Bristol-Myers Squibb
Unspecified Adult Solid Tumor, Protocol Specific
Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
- Trial name
- NCT00002482
- Testing
- antibody therapy, biological therapy, muromonab-CD3
- Where
- United States
- Sponsor
- St. Vincent Medical Center - Los Angeles
Indolent B-cell Lymphoma, Chronic Lymphocytic Leukaemia
A Phase I Trial of DI-B4 in Patients With Advanced CD19 Positive Indolent B-cell Malignancies
The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed.
- Conditions
- Indolent B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinaemia
- Trial name
- NCT01805375
- Testing
- DI-B4
- Where
- 5 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Cancer Research UK
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