Clinical trials: Clinical Trial, Phase I
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Malaria
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP).
- Trial name
- NCT05891236
- Testing
- MAM01 1.5 mg/kg, MAM01 5 mg/kg, MAM01 10 mg/kg
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Neoplasms
Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior…
- Trial name
- NCT02964507
- Testing
- GSK525762, Fulvestrant
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery
This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck…
- Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Unresectable Head and Neck Squamous Cell Carcinoma
- Trial name
- NCT01468896
- Testing
- Cetuximab, Edodekin alfa, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- National Cancer Institute (NCI)
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Healthy
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of [14C]-BI 207127 and to characterize the metabolic profile following single dose administration.
- Trial name
- NCT01605461
- Testing
- BI 207127 NA
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bipolar Disorder
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
- Trial name
- NCT00257166
- Testing
- Ziprasidone oral capsules
- Where
- 50 sites in United States
- Volunteers
- 238 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Metastatic Disease
BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients with advanced and/or metastatic…
- Trial name
- NCT01679405
- Testing
- BIBW 2992
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Johannes Gutenberg University Mainz
Knee Osteoarthritis
Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee
This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA 4P-004 in participants, Between 18 and 80 years of age, with target knee…
- Trial name
- LASARE (NCT05419856)
- Testing
- 4P-004
- Where
- 3 sites in Belgium
- Volunteers
- 34 people
- Sponsor
- 4Moving Biotech
Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Types II or III
The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if the drug has an effect on SMN mRNA and protein levels.
- Trial name
- NPTUNE01 (NCT00439569)
- Testing
- sodium phenylbutyrate
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Westat
Brain and Central Nervous System Tumors, Melanoma
Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma
RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing.
- Conditions
- Brain and Central Nervous System Tumors, Melanoma, Solid Tumor
- Trial name
- NCT00512798
- Testing
- PS-341 (VELCADE), temozolomide, immunoenzyme technique
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Leukemia, Myeloid, Acute
Azacitidine and Lenalidomide for Acute Myeloid Leukemia
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
- Trial name
- NCT01016600
- Testing
- Lenalidomide, Azacitidine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Washington University School of Medicine
Refractory Differentiated Thyroid Gland Carcinoma, Refractory Thyroid Gland Follicular Carcinoma
Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer
This partially randomized phase I/II trial studies the side effects and best dose of cediranib maleate when given together with or without lenalidomide and to see how well they work in treating patients with thyroid cancer.
- Conditions
- Refractory Differentiated Thyroid Gland Carcinoma, Refractory Thyroid Gland Follicular Carcinoma, Refractory Thyroid Gland Hurthle Cell Carcinoma, Refractory Thyroid Gland Papillary Carcinoma
- Trial name
- NCT01208051
- Testing
- Cediranib, Cediranib Maleate, Laboratory Biomarker Analysis
- Where
- 33 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- National Cancer Institute (NCI)
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
This study was an open-label single-dose gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec intravenous (IV) administration in boys with DMD.
- Trial name
- NCT03375164
- Testing
- delandistrogene moxeparvovec
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Sarepta Therapeutics, Inc.
Healthy
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
- Trial name
- NCT01608087
- Testing
- BI 695502, bevacizumab
- Where
- 2 sites in New Zealand
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatitis E, Immunisation
Safety Study of Hepatitis E Vaccine (HEV239)
This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant…
- Trial name
- NCT03827395
- Testing
- HEV 239
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back (recurrent)…
- Trial name
- NCT00450814
- Testing
- Cyclophosphamide, Laboratory Biomarker Analysis, Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Mayo Clinic
Recurrent Glioblastoma
Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma
Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.
- Trial name
- NCT03430791
- Testing
- Nivolumab 240 mg IV, Nivolumab 3 mg/kg, Ipilimumab 1 mg/kg
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Baptist Health South Florida
HIV-1 Infections
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo…
- Trial name
- NCT00799058
- Testing
- dapivirine 4789, dapivirine gel 4759
- Where
- 5 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult…
- Trial name
- HVTN139 (NCT05182125)
- Testing
- AdC6-HIVgp140, AdC7-HIVgp140, CH505TF gp120
- Where
- 6 sites in South Africa
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
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