Antibody-based therapeutics to watch in 2011.

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Published in MAbs on January 01, 2011

Authors

Janice M Reichert1

Author Affiliations

1: Tufts Center for the Study of Drug Development, Boston, MA, USA. janice.reichert@tufts.edu

Associated clinical trials:

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma | NCT00324155

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma | NCT00094653

Study of Immunotherapy to Treat Advanced Prostate Cancer | NCT00861614

Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer | NCT01057810

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer (CLEOPATRA) (CLEOPATRA) | NCT00567190

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY 2) | NCT01042379

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE) | NCT01120184

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA) | NCT00829166

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier) | NCT00574132

Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION) | NCT00905372

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52) | NCT00424476

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76) | NCT00410384

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib (REACH) | NCT01140347

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma | NCT00917384

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer (VENICE) | NCT00519285

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma | NCT00636168

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma (RAINBOW) | NCT01170663

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) | NCT01100502

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier) | NCT00575055

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy | NCT01168973

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR) | NCT00561470

A Study in Second Line Metastatic Colorectal Cancer | NCT01183780

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer | NCT01204749

Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION2) | NCT00904683

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (SQUIRE) | NCT00981058

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma | NCT00848926

Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer | NCT00703326

Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse | NCT00849667

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) | NCT01010061

Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) (APRIL-SLE) | NCT00624338

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (INSPIRE) | NCT00982111

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus | NCT00385697

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients | NCT00676143

Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer (VANILLA) | NCT00574275

Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients | NCT00667810

AAB-001 in Patients With Mild to Moderate Alzheimer's Disease | NCT00112073

Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer | NCT00087022

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI LTS) | NCT00790933

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II) | NCT00783692

Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1 (DEFEND-1) | NCT00678886

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY) | NCT01061736

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States | NCT00724867

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2) | NCT00637377

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 | NCT00712933

Study of Dalotuzumab (MK0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004 AM9) | NCT00614393

Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (INSURE) | NCT01095250

A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (VITAL) | NCT00532155

A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN) | NCT00517530

Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW1) | NCT00509795

Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer | NCT00479817

DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC | NCT00496652

Nimotuzumab in Adults With Glioblastoma Multiforma | NCT00753246

ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma | NCT00420888

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis (ENDURE) | NCT01032915

Phase III Study in Refractory Behcet's Disease (SHIELD) | NCT00995709

Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer | NCT01074021

A Study of Ramucirumab in Participants With Metastatic Renal Cell Carcinoma | NCT00515697

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease | NCT00624351

Study of Epratuzumab in Systemic Lupus Erythematosus | NCT00383513

Zalutumumab in Patients With Non-curable Head and Neck Cancer | NCT00382031

A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis | NCT00679731

Continued Safety Monitoring of Solanezumab in Alzheimer's Disease (EXPEDITION EXT) | NCT01127633

A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients | NCT00996918

CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers (CASIMAS) | NCT00822809

Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis | NCT00646399

Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B | NCT01027364

38 Week Extension Study to CAIN457C2303 (SHIELD) | NCT01093846

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001 | NCT01196208

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A | NCT01027377

Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) | NCT00383214

Study of Epratuzumab in Systemic Lupus Erythematosus | NCT00111306

Phase I/IIa Study of FIXFc in Hemophilia B Patients | NCT00716716

Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years | NCT00538434

Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites | NCT00327444

Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients | NCT00627146

Open Label Continuation Study in Moderate to Severe Psoriasis | NCT00626002

Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis | NCT00710580

Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis | NCT00691964

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus | NCT00920582

A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients | NCT00998764

Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma | NCT00587288

A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis | NCT00570986

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A | NCT01181128

Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01) | NCT00870818

Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis | NCT00635089

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) | NCT01146652

Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2 (DEFEND-2) | NCT01123083

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO) | NCT01012973

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) | NCT00943072

Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | NCT00619489

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis (SUSTAIN) | NCT01118728

A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer | NCT00679211

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis (ENDURE) | NCT01090310

Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin. | NCT00071071

Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin. | NCT00071084

Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome | NCT00127881

Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD) | NCT00964795

NCT 00257205

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