Clinical trials: BTC
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.
Advanced Solid Tumors, HER2 Mutation
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety…
- Trial name
- panSOHO (NCT06760819)
- Testing
- BAY2927088
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Bayer
HER2 Expression / Amplification in Patients With Biliary Tract Cancer
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic…
- Trial name
- NCT06413745
- Testing
- SHR-A1811
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Biliary Tract Cancers (BTC)
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis.
- Trial name
- NCT06611345
- Testing
- Tumor Treating Fields, Durvalumab, Gemcitabine
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Advanced MTAP-null Solid Tumors
A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with…
- Trial name
- MTAPESTRY 101 (NCT05094336)
- Testing
- Anvumetostat, Docetaxel, Comparator Anvumetostat Test Tablet
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 329 people
- Sponsor
- Amgen
Advanced Biliary Tract Cancer
IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer
This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC
- Trial name
- NCT05653180
- Testing
- IBI310, sintilimab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Advanced Cancer
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer
- Trial name
- NCT04900818
- Testing
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy, TJ033721 (givastomig), chemotherapy
- Where
- 21 sites in United States, China
- Volunteers
- 330 people
- Sponsor
- I-Mab Biopharma US Limited
Advanced Biliary Tract Cancer
A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with…
- Trial name
- NCT07229625
- Testing
- SHR-8068 Injection, Adebrelimab Injection, Gemcitabine Hydrochloride for Injection
- Where
- China
- Volunteers
- 604 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Biliary Tract Cancer (BTC)
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
- Trial name
- NCT06622057
- Testing
- D07001-Softgel Capsules, Capecitabine
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 240 people
- Sponsor
- InnoPharmax 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
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC).
- Trial name
- NCT04784520
- Testing
- HA121-28 tablets
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Biliary Tract Cancer
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and…
- Trial name
- NCT02579616
- Testing
- Lenvatinib
- Where
- 7 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Eisai Co., Ltd.
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.
Solid Tumors
A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
- Trial name
- NCT04704154
- Testing
- Regorafenib, (Stivarga, BAY73-4506), Nivolumab (Opdivo)
- Where
- 34 sites in United States, Belgium and 6 more
- Volunteers
- 175 people
- Sponsor
- Bayer
Selected Advanced Solid Tumors, Colorectal Cancer (CRC)
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors.
- Conditions
- Selected Advanced Solid Tumors, Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07812805
- Testing
- SKL35501, SKL35502
- Where
- 5 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- SK Life Science, Inc.
Advanced Biliary Tract Cancer(BTC)
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Primary Objective: To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer Secondary Objectives: To evaluate overall response rate (ORR) To evaluate…
- Trial name
- NCT02425137
- Testing
- S-1/Gemcitabine
- Where
- 4 sites in Taiwan
- Volunteers
- 51 people
- Sponsor
- TTY Biopharm
Colorectal Cancer, Gastro Esophageal Junctional Cancer
IKS04 Regimen in Advanced Solid Tumors That Express CA242
This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further…
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma
- Trial name
- NCT07738939
- Testing
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Iksuda Therapeutics Ltd.
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.
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