Clinical trials: Biliary Disease
Bladder Cancer, Biliary Tract Cancer
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
In DESTINY-Pan-Tumor [DP-02], DESTINY CRC02 [DC-02], and DESTINY-Lung01 [DL-01], T-DXd demonstrated tumor response across a broad range of HER2-expressing solid tumors, particularly IHC3+ patients.
- Conditions
- Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer
- Trial name
- NCT06973161
- Where
- 27 sites in United States, Austria and 10 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Ovarian, Melanoma
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid…
- Conditions
- Ovarian, Melanoma, Renal, Prostate
- Trial name
- NCT00423254
- Testing
- PSMA/PRAME
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Mannkind Corporation
Biliary Tract Cancers (BTC)
Cosiporfin Sodium for Injection Photodynamic Therapy
Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery.
- Trial name
- DVDMS (NCT07398339)
- Testing
- Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection, Cisplatin for injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Guangsheng Biopharmaceutical 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.
Irritable Bowel Syndrome, Gallstone Disease
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in…
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia
- Trial name
- NCT07421011
- Testing
- Trimedat®
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan…
- Conditions
- Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
- Trial name
- NCT05009953
- Testing
- Irinotecan Liposome Injection, SG001, Fluorouracil
- Where
- China
- Volunteers
- 17 people
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Primary Sclerosing Cholangitis
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.
- Trial name
- NUC-3 (NCT01755507)
- Testing
- norUDCA
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 159 people
- Sponsor
- Dr. Falk Pharma GmbH
Cancer of the Bile Duct, Gallbladder Cancer
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer
The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall…
- Trial name
- NCT00386516
- Testing
- GM-CT-01, 5-Fluorouracil
- Where
- 3 sites in United States
- Sponsor
- Galectin Therapeutics Inc.
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Biliary Tract Cancer
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed…
- Trial name
- NCT05065957
- Testing
- D07001-softgel capsules + Xeloda (or TS-1), mFOLFOX
- Where
- 5 sites in Taiwan
- Volunteers
- 180 people
- Sponsor
- InnoPharmax Inc.
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04838964
- Testing
- MRG003
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
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
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Cancer
A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers
This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers…
- Trial name
- NCT01943864
- Testing
- Trametinib (single tablet), Trametinib (Multiple tablet)
- Where
- 5 sites in Japan
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Primary Sclerosing Cholangitis (PSC)
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of…
- Trial name
- NCT03766035
- Testing
- SpyGlass DS I - II
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation
Pancreatic Diseases, Bile Duct Diseases
SpyGlass Surgical Study
To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope To identify specific surgical procedures in which intraoperative use of a thin…
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Trial name
- NCT05822635
- Testing
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Where
- 5 sites in United States, China and 2 more
- Volunteers
- 34 people
- Sponsor
- Boston Scientific Corporation
Primary Sclerosing Cholangitis
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.
- Trial name
- ALPINE-PSC (NCT06654726)
- Testing
- aldafermin
- Sponsor
- NGM Biopharmaceuticals, Inc
Cancer, Neoplasms
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
- Conditions
- Cancer, Neoplasms, Neoplasms, Breast, Tumor
- Trial name
- NCT06819215
- Testing
- VB15010
- Where
- China
- Volunteers
- 188 people
- Sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Primary Biliary Cholangitis (PBC)
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose.
- Trial name
- NCT06798454
- Testing
- PVT201
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.