Clinical trials: Digestive Tract Diseases
Solid Tumors, Advanced Cancer
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
To assess: efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion…
- Conditions
- Solid Tumors, Advanced Cancer, Renal Cancer, Gastric Cancer
- Trial name
- SPARTA (NCT03175224)
- Testing
- APL-101 Oral Capsules
- Where
- 35 sites in United States, Australia and 9 more
- Volunteers
- 497 people
- Sponsor
- Apollomics Inc.
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA
Sarcoma, Melanoma
A Study of PRT1419 in Patients With Advanced Solid Tumors
This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors.
- Conditions
- Sarcoma, Melanoma, Lung Cancer, Breast Cancer
- Trial name
- NCT04837677
- Testing
- PRT1419
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- Prelude Therapeutics Incorporated
Mesothelioma, Non Small Cell Lung Cancer
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the…
- Conditions
- Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor
- Trial name
- NCT05245500
- Testing
- MRTX1719
- Where
- 25 sites in United States
- Volunteers
- 336 people
- Sponsor
- Bristol-Myers Squibb
Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome…
- Conditions
- Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer
- Trial name
- NCT03829436
- Testing
- Part 1 TPST-1120, Part 2 TPST-1120 + nivolumab, Part 3 TPST-1120
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Tempest Therapeutics
Cystic Fibrosis
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.
- Trial name
- NCT02875366
- Testing
- LUM/IVA
- Where
- 12 sites in Australia, United Kingdom
- Volunteers
- 70 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Immunotherapy, Cancer
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
- Conditions
- Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder
- Trial name
- ELEPHAS-02 (NCT05520099)
- Testing
- Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Where
- 12 sites in United States
- Volunteers
- 416 people
- Sponsor
- Elephas
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Biliary Tract Cancer
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
- Trial name
- AB02 (NCT07221253)
- Testing
- Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin
- Where
- 183 sites in United States, Australia and 17 more
- Volunteers
- 1,100 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation (3849 +10kb C-->T).
- Trial name
- NCT06429176
- Testing
- SPL84
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- SpliSense Ltd.
Whole Cell Pertussis, Haemophilus Influenzae Type b
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as…
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus, Diphtheria
- Trial name
- NCT00473668
- Testing
- Zilbrix-Hib, Tritanrix™-HepB/ Hiberix™
- Where
- 3 sites in India
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Cancer, Non Small Cell Lung Cancer
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Cancer of Pancreas
- Trial name
- NCT05485974
- Testing
- HBI-2438
- Where
- 14 sites in United States, Puerto Rico
- Volunteers
- 44 people
- Sponsor
- HUYABIO International, LLC.
Head and Neck Cancer, Liver Cancer
A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors.
- Conditions
- Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer
- Trial name
- NCT01171924
- Testing
- CUDC-101
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Curis, Inc.
Cystic Fibrosis
A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis
This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ…
- Trial name
- NCT02951182
- Testing
- TEZ, IVA, VX-440
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 74 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Diphtheria, Tetanus
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT04073459
- Testing
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Cystic Fibrosis
A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis
This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF…
- Trial name
- NCT03045523
- Testing
- GLPG2222 150 mg q.d., GLPG2222 300 mg q.d.
- Where
- 22 sites in Australia, Belgium and 4 more
- Volunteers
- 37 people
- Sponsor
- Lakefront Biotherapeutics NV
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Advanced Solid Tumors, Lymphoma
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance.
- Conditions
- Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT03841110
- Testing
- FT500, Nivolumab, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Fate Therapeutics
Advanced Cancer, Gastric Adenocarcinoma
A Study of Emibetuzumab in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer
The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab when given with ramucirumab that may be safely given to participants with cancer.
- Conditions
- Advanced Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Hepatocellular Cancer
- Trial name
- NCT02082210
- Testing
- Emibetuzumab, Ramucirumab
- Where
- 4 sites in United States
- Volunteers
- 97 people
- Sponsor
- Eli Lilly and Company
Cholangiocarcinoma, Bile Duct Inflammation
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer.
- Trial name
- FOCUS (NCT01392274)
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 121 people
- Sponsor
- Mauna Kea Technologies
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