Clinical trials: Protein
Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC)
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer, Gastric Cancer
- Trial name
- NCT06943521
- Testing
- MT-4561
- Where
- 6 sites in United States, Japan
- Volunteers
- 27 people
- Sponsor
- Tanabe Pharma America, Inc.
CD55-deficient Protein-losing Enteropathy
Compassionate Use of Pozelimab
Provide compassionate use of pozelimab
- Trial name
- NCT05232110
- Testing
- Pozelimab
- Sponsor
- Regeneron Pharmaceuticals
CD55-Deficient Protein-Losing Enteropathy
Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy
The program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with Protein-Losing Enteropathy (PLE).
- Trial name
- CHAPLE Disease (NCT06003881)
- Testing
- Pozelimab
- Sponsor
- Regeneron Pharmaceuticals
Refractory Metastatic Colorectal Cancer, Solid Tumor
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients.
- Conditions
- Refractory Metastatic Colorectal Cancer, Solid Tumor, Metastatic Microsatellite-stable Colorectal Cancer, Mismatch Repair Protein Proficient
- Trial name
- NCT05205330
- Testing
- CR6086, AGEN2034
- Where
- 3 sites in Italy
- Volunteers
- 107 people
- Sponsor
- Rottapharm Biotech
Hemophilia A
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in combination with prophylactic corticosteroids in patients with severe hemophilia A.
- Trial name
- GENEr8-3 (NCT04323098)
- Testing
- valoctocogene roxaparvovec
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 22 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia B
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic…
- Trial name
- B-MORE (NCT03901755)
- Testing
- Alprolix
- Where
- 29 sites in Czechia, Greece and 7 more
- Volunteers
- 151 people
- Sponsor
- Swedish Orphan Biovitrum
CD55-deficient Protein-losing Enteropathy, CHAPLE
Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)
The primary objective of the study is to determine the effect of pozelimab on active CD55-deficient protein-losing enteropathy (PLE; CHAPLE).
- Trial name
- NCT04209634
- Testing
- Pozelimab
- Where
- 3 sites in United States, Thailand and 1 more
- Volunteers
- 10 people
- Sponsor
- Regeneron Pharmaceuticals
Hemophilia A, Gene Therapy
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe…
- Conditions
- Hemophilia A, Gene Therapy, Clotting Disorders, Blood Disorder
- Trial name
- GENEr8-AAV5+ (NCT03520712)
- Testing
- Valoctocogene Roxaparvovec
- Where
- 9 sites in South Africa, South Korea and 2 more
- Volunteers
- 3 people
- Sponsor
- BioMarin Pharmaceutical
Protein Kinase Inhibitors, Other Protocol Specified Criteria
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
- Conditions
- Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms
- Trial name
- JYP0322 (NCT06128148)
- Testing
- JYP0322 50 mg qd, JYP0322 100 mg qd, JYP0322 200 mg qd
- Where
- China
- Volunteers
- 101 people
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.
Cow Milk Protein Allergy
CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
- Trial name
- CMPA-GO (NCT06830681)
- Testing
- New generation eHF, Commercial eHF
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- Société des Produits Nestlé (SPN)
Congenital Protein C Deficiency
A Study of TAK-662 for Japanese Patients With Congenital Protein C Deficiency
Pharmacokinetic Part: This study is for Japanese participants with congenital protein C deficiency. The main aim of this study is to check how much TAK-662 stays in their blood over time.
- Trial name
- NCT04984889
- Testing
- TAK-662
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Takeda
Severe Haemophilia A
Gene Therapy Study in Severe Haemophilia A Patients (270-201)
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, dose escalation study in order to determine the safety and efficacy of valoctocogene roxaparvovec (an Adenovirus-Associated Virus based gene therapy…
- Trial name
- NCT02576795
- Testing
- valoctocogene roxaparvovec
- Where
- 5 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Mild to Moderate Cows' Milk Protein Allergy
Tolerance of Extensive Hydrolyzed Whey Protein Milk Among Infant With Mild to Moderate CMPA
The goal of this clinical trial is to evaluate the tolerance, safety and efficacy of Nutribaby Royal Pepti Junior (NR Pepti) among infants with mild to moderate Cow's Milk Protein Allergy (CMPA).
- Trial name
- PEACE (NCT06204770)
- Testing
- extensive hydrolyzed protein formula
- Where
- 5 sites in Indonesia
- Volunteers
- 15 people
- Sponsor
- Danone Specialized Nutrition Indonesia
Hemophilia A
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)
This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP)…
- Trial name
- BMN 270-301 (NCT03370913)
- Testing
- valoctocogene roxaparvovec
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 144 people
- Sponsor
- BioMarin Pharmaceutical
Multiple Myeloma
ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.
- Trial name
- NCT01997840
- Testing
- ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone
- Where
- 2 sites in United States
- Volunteers
- 103 people
- Sponsor
- Celgene
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
(SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as…
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Neoplasms
- Trial name
- NCT04862780
- Testing
- BLU-945, osimertinib
- Where
- 26 sites in United States, Canada and 8 more
- Volunteers
- 177 people
- Sponsor
- Blueprint Medicines Corporation
Hemophilia A, Hemophilia B
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.
- Trial name
- JOIN-us (NCT05856266)
- Testing
- Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US), Haemophilia Joint Health Score (HJHS)
- Where
- 56 sites in Bulgaria, Croatia and 9 more
- Volunteers
- 10 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
A Gene Transfer Study for Hemophilia A
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
- Trial name
- NCT03003533
- Testing
- SPK-8011
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 25 people
- Sponsor
- Spark Therapeutics, Inc.
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc