Clinical trials: Monoclonal
Healthy Volunteers
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg.
- Trial name
- NCT06481215
- Testing
- GNR-068, Stelara®
- Where
- 2 sites in Russia
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Advanced Melanoma
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of…
- Trial name
- NCT05549297
- Testing
- Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice
- Where
- 82 sites in United States, Australia and 10 more
- Volunteers
- 540 people
- Sponsor
- Immunocore Ltd
Oncology, MET Gene Amplification
Sym015 (Anti-MET) in Patients With Advanced Solid Tumor Malignancies
This is the first study to test Sym015 in humans. The primary purpose of this study is to see if Sym015 is safe and effective for patients with advanced solid tumor malignancies without available therapeutic options.
- Conditions
- Oncology, MET Gene Amplification, NSCLC, MET Gene Mutation
- Trial name
- NCT02648724
- Testing
- Sym015
- Where
- 27 sites in United States, Denmark and 4 more
- Volunteers
- 57 people
- Sponsor
- Symphogen A/S
Homozygous Familial Hypercholesterolemia
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
- Trial name
- NCT04031742
- Testing
- IBI306
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Primary Hepatocellular Carcinoma
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
- Trial name
- NCT00966251
- Testing
- CT-011
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- CureTech Ltd
Advanced Cancer
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced or metastatic solid tumors will be enrolled.
- Trial name
- NCT04495296
- Testing
- TST001, Oxaliplatin, Capecitabine
- Where
- 40 sites in China
- Volunteers
- 320 people
- Sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
Multiple Myeloma
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
- Trial name
- NCT07090954
- Testing
- GR1803 injection, Anti-CD38 Monoclonal Antibody
- Where
- 2 sites in China
- Volunteers
- 32 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
B-cell Non-Hodgkins Lymphoma (B-NHL)
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug[s]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).
- Trial name
- ATHENA-1 (NCT05685173)
- Testing
- Odronextamab, REGN5837
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 107 people
- Sponsor
- Regeneron Pharmaceuticals
Relapsed/Refractory, Multiple Myeloma
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone…
- Trial name
- NCT03439280
- Testing
- Mezagitamab, Pomalidomide, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Esophageal Cancer, Gastric Cancer
A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors
This phase II study is a clinical study to explore the efficacy and safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic…
- Conditions
- Esophageal Cancer, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT06008054
- Testing
- SI-B003, BL-B01D1, PD-1 Monoclonal Antibody
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Neoplasms, Peritoneal Neoplasms
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells.
- Conditions
- Breast Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
- Trial name
- NCT01384253
- Testing
- ²¹²Pb-TCMC-Trastuzumab, trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Orano Med LLC
Adult Solid Tumor
Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor
This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic solid tumors.
- Trial name
- NCT05400265
- Testing
- HLX26, HLX10
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai Henlius Biotech
Prostatic Neoplasms
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another)…
- Trial name
- NCT00537381
- Testing
- Docetaxel, Prednisone, Intetumumab
- Where
- 59 sites in United States, Austria and 8 more
- Volunteers
- 131 people
- Sponsor
- Centocor, Inc.
Gastroesophageal-junction Cancer, Monoclonal Antibody
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with…
- Conditions
- Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT06532006
- Testing
- HLX22, Pembrolizumab, Trastuzumab
- Where
- 208 sites in United States, Argentina and 15 more
- Volunteers
- 550 people
- Sponsor
- Shanghai Henlius Biotech
Healthy Volunteers
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
- Trial name
- NCT07248865
- Testing
- CLYM116
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Climb Bio, Inc.
Chronic Hepatitis C
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV).
- Trial name
- NCT00962936
- Testing
- CT-011
- Where
- Israel
- Volunteers
- 13 people
- Sponsor
- CureTech Ltd
Extensive-stage Small-cell Lung Cancer
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.
- Trial name
- NCT06437509
- Testing
- BL-B01D1, PD-1 monoclonal antibody
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Paroxysmal Nocturnal Hemoglobinuria
Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria
The purpose of this study was to determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with paroxysmal nocturnal hemoglobinuria (PNH).
- Trial name
- NCT02534909
- Testing
- LFG316, LNP023
- Where
- 7 sites in Czechia, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor
PTX-35 in Patients With Advanced Solid Tumors
A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care
- Trial name
- NCT04430348
- Testing
- PTX-35
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pelican Therapeutics, Inc.
Atopic Dermatitis (AD)
A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of…
- Trial name
- MG-K10 (NCT07103174)
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
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