Clinical trials: Human Gastrointestinal Tract
Diphtheria, Polio
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
- Conditions
- Diphtheria, Polio, Pertussis, Hepatitis B
- Trial name
- NCT00619502
- Testing
- DTaP-IPV-HB-PRP~T vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00092469
- Testing
- V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Human Gut Microbiome Development
Phages Dynamics and Influences During Human Gut Microbiome Establishment
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology.
- Trial name
- METAKIDS (NCT03296631)
- Testing
- collection of diapers with fresh stools
- Where
- 2 sites in France
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Relapse, Advanced Malignant Neoplasm
A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).
- Conditions
- Relapse, Advanced Malignant Neoplasm, Non Small Cell Lung Cancer, Gastric Cancer
- Trial name
- JIVAN (NCT05861947)
- Testing
- AUR106
- Where
- 6 sites in India
- Volunteers
- 21 people
- Sponsor
- Aurigene Discovery Technologies Limited
Solid Tumors
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b
DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and…
- Trial name
- NCT02279433
- Testing
- DS6051b
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Nuvation Bio Inc.
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
Diphtheria, Tetanus
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00654901
- Testing
- DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
- Where
- 4 sites in Mexico
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Advanced Solid Tumor, Metastatic Solid Tumors
Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET
A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumors, MET Gene Alterations
- Trial name
- SHIELD-1 (NCT03993873)
- Testing
- elzovantinib (TPX-0022)
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 95 people
- Sponsor
- Turning Point Therapeutics, Inc.
Advanced Solid Tumors, Non-Small Cell Lung Cancer
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid Tumors
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events, change in disease activity and pharmacokinetics of ABBV-253.
- Conditions
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT07807956
- Testing
- ABBV-253
- Where
- 3 sites in United States
- Volunteers
- 130 people
- Sponsor
- AbbVie
Diphtheria, Pertussis
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all…
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01917357
- Testing
- Quinvaxem in Uniject, Quinvaxem in single dose vials
- Where
- Philippines
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Neoplasm Malignant, Breast Cancer
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Primary Objectives: Part 1 (Dose Escalation) To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for…
- Conditions
- Neoplasm Malignant, Breast Cancer, Lung Neoplasm Malignant, Gastric Cancer
- Trial name
- NCT05013554
- Testing
- SAR443216 IV, SAR443216 SC
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 44 people
- Sponsor
- Sanofi
Advanced Solid Tumor, RAS Mutation
Safety and Effectiveness of ABM-168 in Adults with Advanced Solid Tumors.
This is a Phase 1, First-in-Human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ABM-168 in adult patients…
- Conditions
- Advanced Solid Tumor, RAS Mutation, RAF Mutation, NF1 Mutation
- Trial name
- NCT05831995
- Testing
- ABM-168
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- ABM Therapeutics Corporation
Ovarian Neoplasms, Pancreatic Neoplasms
A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors
The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab…
- Conditions
- Ovarian Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms
- Trial name
- NCT00841191
- Testing
- CNTO 328; Anti-interleukin-6 monoclonal antibody
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 84 people
- Sponsor
- Centocor, Inc.
Gut Microbiota
Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota
The purpose of this trial is to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces of healthy volunteers.
- Trial name
- NCT02929459
- Testing
- Riboflavin Dose 1, Riboflavin Dose 2
- Where
- Netherlands
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Hepatitis B, Chronic (CHB)
Study of AHB-171 in Chronic Hepatitis B Participants
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated…
- Trial name
- NCT07630727
- Testing
- AHB-171 Injection
- Where
- 10 sites in China
- Volunteers
- 138 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Cystic Fibrosis
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and…
- Trial name
- NCT01684410
- Testing
- Alpha-1 HC 100 mg, Alpha-1 HC 200 mg
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Hepatitis B, Polio
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00401531
- Testing
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Where
- 2 sites in Thailand
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Advanced Solid Tumor, Metastatic Cancer
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer
- Trial name
- NCT05267626
- Testing
- AU-007, Aldesleukin, Avelumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 159 people
- Sponsor
- Aulos Bioscience, Inc.