Clinical trials: Biliary Tract
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.
Cancer of the Liver
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population.
- Trial name
- NCT00422877
- Testing
- Taxoprexin
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- American Regent, Inc.
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Biliary Atresia
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
- Trial name
- NCT04336722
- Testing
- Odevixibat
- Where
- 72 sites in United States, Australia and 17 more
- Volunteers
- 254 people
- Sponsor
- Albireo, an Ipsen Company
Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
- Trial name
- NCT06427395
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- 28 sites in United States, Argentina and 1 more
- Volunteers
- 102 people
- Sponsor
- Zydus Therapeutics Inc.
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.
Colorectal Cancer, Esophagus Cancer
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA…
- Conditions
- Colorectal Cancer, Esophagus Cancer, Gastric Cancer, Pancreas Cancer
- Trial name
- NCT06043466
- Testing
- CEA-targeted CAR-T cells
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Advance Solid Tumors, Colon and Rectal Cancer
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
- Conditions
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC, Pancreatic Adenocarcinoma Advanced or Metastatic
- Trial name
- NCT07610798
- Testing
- INV-8989
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig…
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Colorectal Cancer
- Trial name
- NCT05482893
- Testing
- Spevatamig (PT886), Paclitaxel, Gemcitabine
- Where
- 11 sites in United States
- Volunteers
- 350 people
- Sponsor
- Phanes Therapeutics
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Solid Tumor Cancer, Locally Advanced
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a…
- Conditions
- Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers
- Trial name
- NCT07038343
- Testing
- AVZO-1418, Combination Agent 1, Combination Agent 2
- Where
- 27 sites in United States, China
- Volunteers
- 480 people
- Sponsor
- Avenzo Therapeutics, Inc.
Hepatocellular Carcinoma, Renal Cell Carcinoma
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Carcinoma Primary Differentiated
- Trial name
- NCT07252661
- Testing
- ACC-1898
- Volunteers
- 40 people
- Sponsor
- AccSalus Biosciences, Inc.
Biliary Tract Cancer
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
- Trial name
- NCT00090025
- Testing
- becatecarin, 5-Fluorouracil Plus Leucovorin
- Where
- 59 sites in United States, Belgium and 9 more
- Volunteers
- 248 people
- Sponsor
- Helsinn Healthcare SA
Bacterial Infections and Mycoses, Appendicitis
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
- Conditions
- Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis
- Trial name
- NCT00229060
- Testing
- doripenem
- Volunteers
- 483 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
EGFR Overexpression, Locally Advanced Solid Tumor
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can…
- Conditions
- EGFR Overexpression, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT06975410
- Testing
- YH32364
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Yuhan Corporation
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04837508
- Testing
- MRG002
- Where
- 7 sites in China
- Volunteers
- 86 people
- Sponsor
- Shanghai Miracogen Inc.
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
Biliary Tract Cancer
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer
Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line…
- Trial name
- NCT06465563
- Testing
- SHR-8068, Adebrelimab, Cisplatin
- Where
- 2 sites in China
- Volunteers
- 93 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.