Clinical trials: Bile Duct Disease
Melanoma, Non-small Cell Lung Cancer
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy…
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer
- Trial name
- NCT03329950
- Testing
- CDX-1140, CDX-301, pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 132 people
- Sponsor
- Celldex Therapeutics
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Primary Sclerosing Cholangitis, Inflammatory Bowel Disease
Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD).
- Trial name
- NCT03035058
- Testing
- Vedolizumab
- Sponsor
- Takeda
Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous…
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT04152018
- Testing
- PF-06940434, PF-06801591
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 85 people
- Sponsor
- Pfizer
Primary Sclerosing Cholangitis (PSC)
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
- Trial name
- CAMEO (NCT02061540)
- Testing
- LUM001
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
- Trial name
- ELFINITY (NCT06447168)
- Where
- 72 sites in United States, Australia and 9 more
- Volunteers
- 424 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma 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.
Solid Tumor
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion.
- Trial name
- NCT06336148
- Testing
- ACTM-838
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Actym Therapeutics, Inc.
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Cholestasis, Intrahepatic
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
This will be a randomized, double-blind, placebo-controlled study to assess safety and tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC) and symptoms of pruritus.
- Trial name
- NCT01899703
- Testing
- GSK2330672, Ursodeoxycholic acid
- Where
- 3 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Cholangiocarcinoma
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in…
- Trial name
- RELEASE (NCT04099888)
- Testing
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 41 people
- Sponsor
- PCI Biotech AS
Primary Biliary Cholangitis (PBC)
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response…
- Trial name
- NCT03124108
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 45 people
- Sponsor
- Genfit
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
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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.
Solid Tumor, NSCLC
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or…
- Conditions
- Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer
- Trial name
- NCT07873450
- Testing
- [225Ac]Ac-FL-261
- Where
- 2 sites in United States, Australia
- Volunteers
- 208 people
- Sponsor
- Full-Life Technologies UK Limited
Primary Sclerosing Cholangitis
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02653625
- Testing
- Cenicriviroc 150 mg
- Where
- 9 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- Tobira Therapeutics, Inc.
Primary Biliary Cholangitis
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
- Trial name
- ELSPIRE (NCT06383403)
- Testing
- Elafibranor
- Where
- 60 sites in United States, Czechia and 8 more
- Volunteers
- 92 people
- Sponsor
- Ipsen