Clinical trials: Digestive Tract Diseases
Solid Tumors, Non-Small Cell Lung Cancer
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other…
- Conditions
- Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- HS-20117 (NCT06621563)
- Testing
- HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy, HS-20117 combined HS-20093 and 5-FU
- Where
- China
- Volunteers
- 780 people
- Sponsor
- Hansoh BioMedical R&D Company
Malnutrition, Cancer
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition…
- Conditions
- Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- NCT06055543
- Testing
- Fortimel
- Where
- 6 sites in Spain
- Volunteers
- 140 people
- Sponsor
- Danone Specialized Nutrition
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Trial name
- NCT02269189
- Testing
- BIIL 284 BS, high dose, BIIL 284 BS, low dose
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Neoplasms
A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin.
- Trial name
- NCT00264433
- Testing
- ADH -1 (Exherin™)
- Where
- 11 sites in United States, Canada
- Sponsor
- Adherex Technologies, Inc.
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
Cystic Fibrosis
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).
- Trial name
- NCT03912233
- Testing
- VX-121, TEZ, VX-561
- Where
- 26 sites in United States, Germany and 3 more
- Volunteers
- 87 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Metastatic Solid Tumors, Non-small Cell Lung Cancer
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer
This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination…
- Conditions
- Metastatic Solid Tumors, Non-small Cell Lung Cancer, Melanoma, Head and Neck Squamous Cell Carcinoma
- Trial name
- PDL1x41BB (NCT03809624)
- Testing
- INBRX-105 - PDL1x41BB antibody, Pembrolizumab
- Where
- 23 sites in United States
- Volunteers
- 160 people
- Sponsor
- Inhibrx Biosciences, Inc
Hepatitis C, Chronic, Healthy Volunteer
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01181024
- Testing
- RO5303253
- Where
- New Zealand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Gynecologic Cancer, Colorectal Cancer
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects…
- Conditions
- Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05292859
- Testing
- Neoantigen specific TCR-T cell drug product
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Alaunos Therapeutics
GERD (Gastroesophageal Reflux Disease), NERD
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients.
- Conditions
- GERD (Gastroesophageal Reflux Disease), NERD, Heartburn, Regurgitation, Gastric
- Trial name
- RELIEF (NCT07624383)
- Testing
- Esophageal barrier medical device
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Cellmedis
Solid Tumor, Non-Small Cell Lung Cancer
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer
- Trial name
- NCT04930432
- Testing
- MCLA-129
- Where
- 87 sites in China
- Volunteers
- 400 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Cachexia
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
A safety \& efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
- Trial name
- NCT01433263
- Testing
- BYM338 active drug
- Where
- 10 sites in United States, Lithuania and 3 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Biliary Tract Cancer
A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy
The primary purpose of this study is to investigate the safety of Tasfygo.
- Trial name
- NCT06793709
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Eisai Co., Ltd.
Metastatic Cancer, Solid Tumors
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
- Conditions
- Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer
- Trial name
- NCT02903914
- Testing
- INCB001158, Pembrolizumab
- Where
- 20 sites in United States, Italy and 2 more
- Volunteers
- 260 people
- Sponsor
- Incyte Corporation
Advanced Cancer, Refractory Cancer
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are…
- Conditions
- Advanced Cancer, Refractory Cancer, Tumor Gastric
- Trial name
- NCT04861987
- Testing
- PCS6422 and capecitabine
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Processa Pharmaceuticals
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis (PSC)
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and…
- Trial name
- AESOP (NCT02177136)
- Testing
- Obeticholic Acid (OCA)
- Where
- 36 sites in United States, Italy
- Volunteers
- 77 people
- Sponsor
- Intercept Pharmaceuticals
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