Clinical trials: Biliary Tract Cancers
Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728.
- Trial name
- NCT03410927
- Testing
- TAS0728
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Taiho Oncology, Inc.
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
Biliary Tract Cancer
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT06591520
- Testing
- AK112, Gemcitabine, Cisplatin, Durvalumab, Gemcitabine, Cisplatin
- Where
- 2 sites in China
- Volunteers
- 682 people
- Sponsor
- Akeso
Gastrointestinal Cancer, Prostate Cancer
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response.
- Conditions
- Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female
- Trial name
- NCT00332280
- Testing
- AMT2003
- Where
- 2 sites in Bosnia and Herzegovina, Germany
- Volunteers
- 67 people
- Sponsor
- Auron Healthcare GmbH
Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This example phase 1/2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic…
- Conditions
- Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
- Trial name
- DUET-BTC (NCT07641036)
- Testing
- EB-HC01 dual-target CARNK cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Biotech
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)
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- KEYNOTE-966 (NCT04003636)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 185 sites in United States, Argentina and 22 more
- Volunteers
- 1,069 people
- Sponsor
- Merck Sharp & Dohme LLC
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.
- Trial name
- DPT02 (NCT04482309)
- Testing
- Trastuzumab deruxtecan
- Where
- 89 sites in United States, Australia and 15 more
- Volunteers
- 477 people
- Sponsor
- AstraZeneca
Advanced Biliary Tract Cancer
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
An open label study to determine the efficacy and safety of SPARC1507
- Trial name
- NCT02597465
- Testing
- SPARC1507, Reference1507
- Where
- United States
- Sponsor
- Sun Pharma Advanced Research Company Limited
Biliary Tract Cancer, Melanoma
HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma
- Trial name
- NCT06708663
- Testing
- HX009+IN10018
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
Solid Tumours
Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors
This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This study is designed to identify recommended doses and regimens in Japanese subjects for the future development of GSK1120212.
- Trial name
- NCT01324258
- Testing
- GSK1120212, Gemcitabine
- Where
- 2 sites in Japan
- Volunteers
- 19 people
- Sponsor
- GlaxoSmithKline
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.
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
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.
Metastatic Cancer, Solid Tumor
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by…
- Trial name
- NCT04641871
- Testing
- Sym021, Sym022, Sym023
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 78 people
- Sponsor
- Symphogen A/S
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.
HER2-Positive Advanced Biliary Tract Cancer
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for…
- Trial name
- NCT04578444
- Testing
- Zanidatamab
- Where
- 17 sites in United States, France and 3 more
- Sponsor
- Jazz Pharmaceuticals
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
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
BCL2 Gene mRNA Overexpression
Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
- Trial name
- miRNA_Chip (NCT02807896)
- Where
- South Korea
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- CHANGHEE LEE
Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
- Trial name
- NCT06434597
- Testing
- SPH5030
- Where
- 30 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd