Clinical trials: Digestive Tract Diseases
Advanced Solid Tumors, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC
- Trial name
- NCT04272034
- Testing
- INCB099318
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Incyte Corporation
Non Small Cell Lung Cancer, Esophageal Cancer
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
- Conditions
- Non Small Cell Lung Cancer, Esophageal Cancer, Small Cell Lung Cancer, Nasopharyngeal Cancer
- Trial name
- NCT05983432
- Testing
- BL-B01D1
- Where
- 37 sites in United States, France and 3 more
- Volunteers
- 540 people
- Sponsor
- SystImmune Inc.
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C).
- Conditions
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
- Trial name
- NCT04956640
- Testing
- LY3537982, Pembrolizumab, Cetuximab
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 540 people
- Sponsor
- Eli Lilly and Company
Cancer, Breast, Cancer, Lung
A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid…
- Conditions
- Cancer, Breast, Cancer, Lung, Cancer of Pancreas, Cancer of Esophagus
- Trial name
- NCT05830097
- Testing
- CBP-1019
- Where
- 5 sites in United States, China
- Volunteers
- 260 people
- Sponsor
- Coherent Biopharma (Hefei) Co., Ltd.
Alpha1-antitrypsin Deficiency
Aralast alpha1-proteinase Inhibitor Surveillance Study
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on…
- Trial name
- NCT00313144
- Testing
- ARALAST Alpha1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Baxalta now part of Shire
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer
Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
A Pilot Phase II Study The primary objective for this study is: To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before…
- Conditions
- Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer, Non-squamous Non-small Cell Lung Cancer
- Trial name
- K5-101 (NCT00988936)
- Testing
- [F-18]RGD-K5
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Siemens Molecular Imaging
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Cancer, Tumor, Solid
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced…
- Conditions
- Cancer, Tumor, Solid, Advanced Solid Tumor, Metastatic Cancer
- Trial name
- NCT05620134
- Testing
- JK08, Pembrolizumab, Lenvatinib Pill
- Where
- 11 sites in Belgium, Spain
- Volunteers
- 263 people
- Sponsor
- Salubris Biotherapeutics Inc
Biliary Tract Cancer
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
- Trial name
- TOURMALINE (NCT05771480)
- Testing
- Durvalumab, Gemcitabine monotherapy, Gemcitabine + cisplatin
- Where
- 34 sites in United States, France and 6 more
- Volunteers
- 142 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor
The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).
- Trial name
- NCT05535959
- Testing
- VX-121/TEZ/D-IVA
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Neoplasms, Non-small-cell Lung Cancer
A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.
The purpose of this study is to learn about the: safety (the effect of the study medicine on the participant's body), effects of the study medicine alone or in combination with sasanlimab - the best amount of the study medicine.
- Conditions
- Neoplasms, Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
- Trial name
- NCT06546553
- Testing
- PF-07826390, sasanlimab, SOC (anti-PD-1 + platinum -based chemo)
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Advanced Cancer, Metastatic Melanoma
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.
- Conditions
- Advanced Cancer, Metastatic Melanoma, Metastatic Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT02857270
- Testing
- LY3214996, Midazolam, Abemaciclib
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 210 people
- Sponsor
- Eli Lilly and Company
Selected Advanced Solid Tumors, Colorectal Cancer (CRC)
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors.
- Conditions
- Selected Advanced Solid Tumors, Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07812805
- Testing
- SKL35501, SKL35502
- Where
- 5 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- SK Life Science, Inc.
Alpha-1 Antitrypsin Deficiency
A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With Pi*ZZ AATD
The purpose of this open-label study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of WVE-006 in participants with alpha-1 antitrypsin deficiency (AATD) following Period 1 single ascending dose…
- Trial name
- NCT06405633
- Testing
- WVE-006
- Where
- 9 sites in Australia, Canada and 4 more
- Volunteers
- 48 people
- Sponsor
- Wave Life Sciences USA, Inc.
Primary Biliary Cholangitis (PBC)
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response…
- Trial name
- NCT03124108
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 45 people
- Sponsor
- Genfit
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Acquired Immunodeficiency Syndrome, Healthy Volunteers
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of…
- Conditions
- Acquired Immunodeficiency Syndrome, Healthy Volunteers, HIV/AIDS, HIV Diarrhea
- Trial name
- NCT04192487
- Testing
- Crofelemer delayed-release tablets 125mg
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Napo Pharmaceuticals, Inc.
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.
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