Clinical trials: Monoclonal Antibody
Lupus
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are…
- Trial name
- NCT00299819
- Testing
- MEDI-545, MEDI 545
- Where
- 21 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- MedImmune LLC
HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants
Part A: The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses.
- Trial name
- HVTN143 (NCT05959707)
- Testing
- VRC01.23LS, PGT121.414.LS, PGDM1400LS
- Where
- 8 sites in South Africa
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Cancer
Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies
JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult subjects with advanced refractory solid tumor malignancies, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose…
- Trial name
- NCT03790488
- Testing
- JTX-4014
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Jounce Therapeutics, Inc.
Tumors
Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies
The purpose of this study is to determine the safety of bavituximab when administered via a vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the body and how long it stays there.
- Trial name
- NCT00129337
- Testing
- Bavituximab
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Peregrine Pharmaceuticals
Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.
The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from B-lymphocyte treatment using the monoclonal anti-CD20…
- Trial name
- RituxME (NCT02229942)
- Testing
- Rituximab
- Where
- 5 sites in Norway
- Volunteers
- 151 people
- Sponsor
- Haukeland University Hospital
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Kidney Transplantation
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT06365437
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 7 sites in Austria, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- ITB-Med LLC
Cutaneous T-Cell Lymphoma
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
- Trial name
- NCT01728805
- Testing
- KW-0761, Vorinostat
- Where
- 73 sites in United States, Australia and 9 more
- Volunteers
- 372 people
- Sponsor
- Kyowa Kirin, Inc.
Scleroderma
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
- Trial name
- MEDI-546 (NCT00930683)
- Testing
- MEDI-546
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- MedImmune LLC
Breast Cancer, Colon Cancer
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer.
- Conditions
- Breast Cancer, Colon Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- Trial name
- NCT02293954
- Testing
- radionuclide imaging, positron emission tomography, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- City of Hope Medical Center
Atopic Dermatitis
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis…
- Trial name
- NCT06765005
- Testing
- MG-K10
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
Diffuse Large B-Cell Lymphoma
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory…
- Trial name
- NCT01453205
- Testing
- MEDI-551 2 mg/kg, Rituximab, ICE
- Where
- 81 sites in United States, Canada and 9 more
- Volunteers
- 187 people
- Sponsor
- MedImmune LLC
Pancreatic Neoplasms, Pancreatic Cancer
Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer
Background: Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving very focused beams of radiation to tumors.
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer, Cancer of Pancreas, Cancer of the Pancreas
- Trial name
- NCT02311361
- Testing
- Durvalumab, Tremelimumab, Sterostatic body radiation therapy (SBRT)
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- National Cancer Institute (NCI)
Colorectal Cancer
A Phase I, Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer.
The purpose of this study is to determine the maximum tolerated dose (which will be the dose recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of movement of the drug within the body…
- Trial name
- NCT02726334
- Testing
- BNC101 Solution for Infusion, BNC101 in combination with FOLFIRI
- Where
- 4 sites in Australia
- Volunteers
- 22 people
- Sponsor
- Bionomics Limited
Multicentric Castleman's Disease
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial…
- Trial name
- NCT01024036
- Testing
- Siltuximab, Best Supportive Care (BSC)
- Where
- 56 sites in United States, Australia and 21 more
- Volunteers
- 79 people
- Sponsor
- Janssen Research & Development, LLC
Extensive Stage Small Cell Lung Cancer
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell…
- Trial name
- NCT04063163
- Testing
- HLX10, carboplatin and etoposide
- Where
- 5 sites in Georgia, Poland and 3 more
- Volunteers
- 585 people
- Sponsor
- Shanghai Henlius Biotech
Sjögren´s Disease
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
- Trial name
- THALASSA (NCT07621809)
- Testing
- VAY736
- Where
- 33 sites in United States, Australia and 6 more
- Volunteers
- 570 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Lung Cancer; Metastatic Lung Cancer
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC.
- Trial name
- NCT03432598
- Testing
- Tislelizumab, Paclitaxel, Gemcitabine
- Where
- 7 sites in China
- Volunteers
- 54 people
- Sponsor
- BeiGene
Crohn's Disease
Monoclonal Antibody Treatment of Crohn's Disease
This study will examine the safety and effectiveness of an experimental drug called J695 for treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine.
- Trial name
- NCT00007163
- Testing
- J695
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smoldering Multiple Myeloma
Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.
- Trial name
- KIRMONO (NCT01222286)
- Testing
- IPH2101
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Innate Pharma
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