Clinical trials: Disorders of Biliary Tract
HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Trial name
- NCT04450732
- Testing
- GQ1001
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 96 people
- Sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
Malignant Mesothelioma, Colorectal Cancer
Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors
This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802…
- Conditions
- Malignant Mesothelioma, Colorectal Cancer, Bile Duct Cancer, Rectal Cancer
- Trial name
- NCT06256055
- Testing
- UCMYM802 Injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- UTC Therapeutics Inc.
Advanced Solid Tumor, Cholangiocarcinoma
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and…
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, Biliary Tract Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05253053
- Testing
- TT-00420, Combination Product: Atezolizumab, Combination Product: Nab-Paclitaxel
- Where
- 9 sites in China
- Volunteers
- 84 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Biliary Tract Cancer
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
- Trial name
- NCT02966821
- Testing
- Surufatinib
- Where
- 5 sites in China
- Volunteers
- 39 people
- Sponsor
- Hutchison Medipharma Limited
HER2-Positive Solid Tumor
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.
- Trial name
- NCT05523947
- Testing
- YH32367
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 147 people
- Sponsor
- Yuhan Corporation
HER2 Mutation-Related Tumors, HER2 Amplified Solid Tumors
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)
A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)
- Trial name
- NCT05041972
- Testing
- ARX788
- Where
- 2 sites in United States
- Sponsor
- Ambrx, Inc.
Primary Biliary Cirrhosis
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02026401
- Testing
- NGM282
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Pancreatic Neoplasms, Cholestasis
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubinemia secondary to bile…
- Trial name
- NCT02267707
- Testing
- nab-paclitaxel, Gemcitabine
- Where
- 6 sites in United States, Germany
- Volunteers
- 1 people
- Sponsor
- Celgene
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG
Advanced Solid Tumours
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.
- Trial name
- KEYNOTE-E86 (NCT04907851)
- Testing
- RXC004, Denosumab, pembrolizumab
- Where
- 13 sites in Australia, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Redx Pharma Ltd
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis (PBC)
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.
- Trial name
- NCT07906639
- Testing
- Elafibranor
- Volunteers
- 50 people
- Sponsor
- Ipsen
Biliary Cirrhosis, Primary
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials.
- Trial name
- NCT02932449
- Where
- 39 sites in United States
- Volunteers
- 711 people
- Sponsor
- Target PharmaSolutions, Inc.
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, 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
Gastric Cancer Adenocarcinoma Metastatic, Ovarian Cancer
Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors
This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors.
- Conditions
- Gastric Cancer Adenocarcinoma Metastatic, Ovarian Cancer, Bile Duct Cancer
- Trial name
- NCT06730581
- Testing
- Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2, Utidelone Capsule
- Volunteers
- 100 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Intrahepatic Cholestasis of Pregnancy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum Pharmaceuticals, Inc.