Clinical trials: Advanced Biliary Tract Carcinoma
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Solid Tumor, Solid Carcinoma
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV)…
- Conditions
- Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer
- Trial name
- MAST (NCT05346484)
- Testing
- CF33-hNIS, Pembrolizumab, Modified FOLFOX
- Where
- 12 sites in United States, Australia
- Volunteers
- 66 people
- Sponsor
- Imugene Limited
Advanced Non-small-cell Lung Cancer, Advanced Biliary Tract Cancer
A Phase 1/2 Study of SC-43 in Combination With Cisplatin
SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination with Cisplatin in…
- Trial name
- NCT04733521
- Testing
- SC-43, Cisplatin
- Volunteers
- 100 people
- Sponsor
- RaND Biosciences
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Biliary Tract Carcinoma
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Carcinoma
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint.
- Trial name
- NCT05987358
- Testing
- TQB3454 tablets
- Where
- 6 sites in China
- Volunteers
- 165 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Ovarian Cancer, Breast Cancer
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid…
- Conditions
- Ovarian Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer
- Trial name
- PETRA (NCT04644068)
- Testing
- AZD5305, Paclitaxel, Carboplatin
- Where
- 68 sites in United States, Australia and 12 more
- Volunteers
- 702 people
- Sponsor
- AstraZeneca
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
Solid Tumor, Adult, Pancreatic Ductal; Adenocarcinoma
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors
This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where…
- Conditions
- Solid Tumor, Adult, Pancreatic Ductal; Adenocarcinoma, Ovarian Serous Adenocarcinoma, Biliary Cancer Metastatic
- Trial name
- NCT05074472
- Testing
- ZB131
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- ZielBio, Inc.
NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC)
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine…
- Conditions
- NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus
- Trial name
- NCT07277413
- Testing
- IDE892, IDE397
- Where
- 23 sites in United States
- Volunteers
- 260 people
- Sponsor
- IDEAYA Biosciences
HER2-positive Solid Tumors, HER2-positive Breast Cancer
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
- Conditions
- HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Gastroesophageal Cancer
- Trial name
- NCT04278144
- Testing
- BDC-1001, Nivolumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 175 people
- Sponsor
- Bolt Biotherapeutics, Inc.
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
Biliary Tract Cancer, Cholangiocarcinoma
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gall Bladder Cancer, Ampullary Cancer
- Trial name
- NCT05506943
- Testing
- CTX-009, Paclitaxel
- Where
- 34 sites in United States
- Volunteers
- 168 people
- Sponsor
- Compass Therapeutics
Ovarian Cancer, Breast Cancer
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced…
- Conditions
- Ovarian Cancer, Breast Cancer, Endometrial Cancer, Biliary Tract Cancer
- Trial name
- LNCB74-01 (NCT06774963)
- Testing
- LNCB74
- Where
- 14 sites in United States
- Volunteers
- 145 people
- Sponsor
- NextCure, Inc.
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
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.
Biliary Tract Cancer
Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer
The term of biliary tract cancer (BTC) or cholangiocarcinoma refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder.
- Trial name
- NCT03937895
- Testing
- 'SMT-NK' Inj (allogeneic Natural Killer cell), Pembrolizumab Injection [Keytruda]
- Where
- 2 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- SMT bio Co., Ltd.
Hepatobiliary Cancers
Observational Study Protocol: LIVER-R
Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications.
- Trial name
- LIVER-R (NCT06252753)
- Testing
- Durvalumab-based combination therapies in observational study setting, Non Durvalumab-based therapies in observational study setting, Durvalumab-based combination therapies in observational study settings
- Where
- 160 sites in United States, Australia and 20 more
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
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