Clinical trials: Disorders of Biliary Tract
Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies
This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer.
- Conditions
- Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma, Biliary Tract Cancer, Extranodal NK T Cell Lymphoma, Nasal
- Trial name
- NCT03999658
- Testing
- STI-3031
- Sponsor
- Sorrento Therapeutics, Inc.
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
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
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Tract Cancer
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
- Trial name
- NCT00380588
- Testing
- gemcitabine, cisplatin
- Where
- 7 sites in Japan
- Volunteers
- 84 people
- Sponsor
- Eli Lilly and Company
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
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
Colorectal Adenocarcinoma, Gastric Adenocarcinoma
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.
- Conditions
- Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Bile Duct Carcinoma
- Trial name
- NCT03507998
- Testing
- CGX1321
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- Curegenix Inc.
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.
Lung Cancer, Melanoma
A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours
This is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab…
- Conditions
- Lung Cancer, Melanoma, Head and Neck Carcinoma, Gastroesophageal Cancer
- Trial name
- NCT02586987
- Testing
- Selumetinib, MEDI4736, Tremelimumab
- Where
- 6 sites in United States
- Volunteers
- 58 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer
- Trial name
- NCT05429697
- Testing
- SMT-NK inj.+Pembrolizumab, Pembrolizumab
- Where
- 3 sites in South Korea
- Volunteers
- 128 people
- Sponsor
- SMT bio Co., Ltd.
Biliary Atresia
Obeticholic Acid in Pediatric Subjects With Biliary Atresia
This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in…
- Trial name
- CARE (NCT05321524)
- Testing
- OCA 0.1mg, OCA 1.5mg, OCA 5mg
- Where
- 17 sites in Belgium, France and 7 more
- Volunteers
- 7 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Tract Cancer, Cholangiocarcinoma
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current…
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT04066491
- Testing
- M7824, Gemcitabine, Cisplatin
- Where
- 99 sites in United States, Argentina and 13 more
- Volunteers
- 309 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Advanced Solid Tumors
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor…
- Trial name
- NCT01938612
- Testing
- MEDI4736, tremelimumab
- Where
- 21 sites in Japan, South Korea and 1 more
- Volunteers
- 269 people
- Sponsor
- AstraZeneca
Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms
A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.
This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors…
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT07623642
- Testing
- GV20-0251, anti-PD-1 monoclonal antibodies
- Where
- 2 sites in China
- Volunteers
- 227 people
- Sponsor
- GV20 Therapeutics
Colorectal Cancer, Gastric Adenocarcinoma
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with…
- Conditions
- Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma
- Trial name
- NCT07544589
- Testing
- DISP-10
- Where
- 7 sites in United States
- Volunteers
- 66 people
- Sponsor
- Dispatch Biotherapeutics
Solid Tumors Harboring NTRK Fusion
A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
- Trial name
- NAVIGATE (NCT02576431)
- Testing
- BAY2757556 (Larotrectinib, Vitrakvi)
- Where
- 98 sites in United States, Argentina and 23 more
- Volunteers
- 215 people
- Sponsor
- Bayer
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
Gastrointestinal Epithelial Cancer, Gastrointestinal Neoplasms
A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering
A clinical trial to assess the safety and efficacy of genetically-engineered, neoantigen-specific Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing…
- Conditions
- Gastrointestinal Epithelial Cancer, Gastrointestinal Neoplasms, Cancer of Gastrointestinal Tract, Cancer, Gastrointestinal
- Trial name
- NCT04426669
- Testing
- Cyclophosphamide, Fludarabine, Tumor-Infiltrating Lymphocytes (TIL)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Intima Bioscience, Inc.
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.