Clinical Trial
ICP-CL-00303
ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Read MoreZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Biliary Tract Cancer (BTC) such as Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Read MoreHERIZON-BTC-01: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) in Patients with Advanced or Metastatic HER2-Amplified Biliary Tract Cancer, Including Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer
This study will test the effectiveness & safety of zanidatamab (ZW25) as a treatment for biliary tract cancer (including ICC, ECC, and gallbladder cancer) that contain extra copies of a gene called HER2. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer which has progressed following standard of care therapy.
Read MorePhase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC)
Study Name Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC). ClinicalTrials.gov Identifier (if applicable) NCT04566133 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name National Cancer Institute Institution Address 10 Center…
Read MoreIvosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.
Read MoreCRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
Read MoreCAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
Read MoreA Phase I, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of GQ1001, a HER2 Antibody-Drug Conjugate, in Patients with HER2-Positive Advanced Solid Tumors
This is a Phase I dose finding study of GQ1001, an anti-HER2 antibody drug conjugate in adults with HER2-positive solid tumors. GQ1001 is administered once every 21-days. Routine safety lab tests and other necessary medical monitoring will be conducted by the site medical staff during the study.
Read MoreTesting the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
This phase II trial studies how well the drug pevonedistat—when given alone or in combination with chemotherapy (paclitaxel and carboplatin)—works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read MoreNuTIde:121
NUC-1031, a new type of chemotherapy drug (called a ProTide) kills cancer cells by preventing DNA replication, similar to gemcitabine. There are several cancer resistance mechanisms known to limit the effectiveness of gemcitabine. NUC-1031 has been specifically designed to overcome these.
Patients will be randomised into NUC-1031 arm or SOC arm
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.
Read MoreA Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)
This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
Read MoreTAS-120-301(FOENIX-CCA3)
FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been
identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.
TELE_ABC Telotristat Ethyl for Advanced Biliary Tract Cancer. A phase 2, multicenter, open-label safety and efficacy study of Xermelo® plus first-line chemotherapy in patients with locally advanced, unresectable, recurrent or metastatic BTC
Eligible patients with signed informed consent receive Telotristat Ethyl 250 mg (1 tab) 3 times daily for the 1st 7 days and then 500 mg (2 tabs) 3 times a day thereafter. Patients will also receive chemotherapy (Gemcitabine & Cisplatin) intravenously on Day 1 and Day 8 of each 21-day cycle, until end of study, progression, or consent withdrawal
Read MoreGemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism).
Read MoreRucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
A combination of PARP inhibitor (daily pill) + immunotherapy (30 min infusion every 2 weeks) in patients with advanced biliary cancer who have not progressed after 4-6 months of first-line chemotherapy (platinum-based).
Read MorePCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer ( RELEASE )
This study contains 2 potential treatment arms and all participants will receive what is considered standard of care for your disease; up to 8 cycles of gemcitabine and cisplatin. Half of the participants will receive in addition the experimental treatment (including the drug Amphinex).
Read MoreFIDES-01: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions or FGFR2 gene mutations or amplifications
Study Name FIDES-01: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions or FGFR2 gene mutations or amplifications ClinicalTrials.gov Identifier (if applicable) NCT03230318 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name Please go to ClinicalTrials.gov to view…
Read MorePembrolizumab (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) (KEYNOTE-966)
This is a study of pembrolizumab plus gemcitabine/cisplatin vs. placebo plus gemcitabine/cisplatin as first-line therapy in people with advanced and/or unresectable BTC.
Read MoreA Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)
To preliminarily evaluate the 6-month progression-free survival (PFS) of combining tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation, TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or with cryoablation or RFA).
Read MorePembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)
A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in Subjects With Advanced Biliary Tract Carcinoma (BTC)
Read MorePhase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer
TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
Read MoreA Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)
Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…
Read MoreDurvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)
This is a Phase III Study of Durvalumab (Immunotherapy) in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. Chemotherapy (Gemcitabine plus Cisplatin) is the standard of care for advanced biliary tract cancer.
Read MoreA Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Read MorePhase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.
Read MoreA Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
This is a global Phase 2 study for 2nd line treatment of patients with advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other FGFR genetic alteration. Patients must have been previously treated with gemcitabine chemotherapy or combination chemotherapy with gemcitabine.
Read MorePROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
Read MoreStudy of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Cycles will continue until disease progression or unacceptable toxicity.
Read MoreA Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients with Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers
This Phase 2 study will be conducted in conjunction with the companion harvest protocol protocol in patients with measurable disease who have lesions that can be resected or biopsied for Tumor Infiltrating Lymphocyte(TIL) growth. The Treatment Phase begins once the cells exceed the cell growth and potency requirements in the companion protocol.
Read MoreA Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Read MoreTree Topp
The study drug, varlitinib, is an investigational anti-tumor product, delivered in the form of tablets. The study drug has been administered as a single and combination treatment to patients with metastatic gastric cancer, gastro-esophageal tumors, breast cancer, and biliary tract cancer (BTC). Laboratory studies and animal research suggest that the study drug stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that the study drug may be effective in targeting and inhibiting (preventing) the pathways of certain proteins in cells called “HER” (human epidermal growth factor receptor). The “HER” protein is important in types of cancer such as cholangiocarcinoma (BTC), gastric cancer, breast cancer, and others. Varlitinib has shown activity in BTC. In this study, patients will receive study drug plus capecitabine, or placebo plus capecitabine. Inclusion allows all forms of BTC and there is no biomarker-based patient selection.
Read MoreGNS561-CL-I-Q-0211: Phase 1/2 Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients with Primary Liver Cancer which includes Intrahepatic cholangiocarcinoma patients
This is a multicenter, open-label, uncontrolled, repeat-dose phase 1/2a study designed to evaluate the safety profile and to determine the Recommended Dose of GNS561 in patients with advanced advanced primary liver cancer (Hepatocarcinoma, Intrahepatic Cholangiocarcinoma). This study consists of 2 parts: escalation and expansion phase.
Read MoreA Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given with Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) alone in Patients with Intrahepatic Cholangiocarcinoma
Patients with intrahepatic cholangiocarcinoma who enroll in this study will receive either Melphalan with the investigational Hepatic Delivery System (called Melphalan/HDS) or Cisplatin and Gemcitabine alone, which is standard of care. Patients who enroll will receive gem/cis followed by melphalan, compared to gem/cis.
Read MoreA Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
This is a phase II study of the combination of 2 immunotherapy drugs (durvalumab and tremelimumab) with radiation therapy in patients with hepatocellular carcinoma (HCC) with an exploratory cohort of patients with metastatic biliary tract cancer (BTC).
Read MoreA Phase 1 Study of CDX-1140, a Fully Human Agonist Anti-CD40 Monoclonal Antibody, in Patients With Advanced Solid Tumors
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further evaluate its safety, tolerability, and efficacy in expansion cohorts once the MTD is determined.
Read MoreABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma
The goal his clinical research study is to learn if the study drug ABC294640 can help to control advanced, unresectable intra-hepatic, perihilar or extra-hepatic cholangiocarcinoma (CCA). The safety of this drug will also be studied.
Read MoreA Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
This is a trial of combining a HDAC inhibitor and a PD1 inhibitor (immunotherapy drug) to make cholangiocarcinoma more sensitive to immunotherapy. This is based on laboratory data that shows HDAC inhibitors can make tumors more sensitive to immunotherapy.
Read MoreA Randomized Phase II Study of Nivolumab in Combination with Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients with Advanced Unresectable Biliary Tract Cancer
The study is investigating the role of immunotherapy in combination with chemotherapy or dual immunotherapy as first line therapy for unresectable or metastatic patients with biliary tract cancer.
Read MoreA Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
This Phase II clinical trial will establish the effectiveness of BGJ398 in patients harboring the FGFR2 gene fusion/translocation, which are errors in the DNA. Adult patients with histologically or cytologically confirmed (tumor biopsy), advanced or metastatic cholangiocarcinoma harboring the FGFR2 gene fusion/ translocation are eligible for enrollment. Phase II clinical trials give doctors more information about the safety of the drug and how well it works.
Approximately 55 adult patients over age 18, both male and female will be enrolled. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule
Read MoreCeramide NanoLiposome in Patients with Advanced Solid Tumors
This study is a dose escalation study to determine the safety and tolerability of Ceramide NanoLiposome in patients with advanced solid tumors.
Read MoreClarIDHy: A Phase 3, multicenter, randomized, double-blind of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.
ClarIDHy is Phase 3, multicenter, randomized (people are allocated by chance to receive one of clinical interventions) double-blind (neither the participant nor the investigator know who is receiving AG-120 or the placebo) of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.
Read MoreA Phase 2 Open-Label Study in Patients with Cholangiocarcinoma
This is an open-label (both the patient and the investigator know what the patient is receiving), Phase 2 study in patient with cholangiocarcinoma who have failed at least one prior line of therapy.
Read MoreImmunotherapy of Cholangiocarcinoma
Earlier version of immunotherapy, which was designed for patients with hepatocellular carcinoma (HCC) has shown limited efficacy in patients with cholangiocarcinoma (CCA). The decline in levels of CA19.9 marker common in CCA correlated with tumor shrinkage.
Read MorePhase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors
An Open-label, Non-Randomized (the participants are not assigned by chance to different treatment groups), Multi-center, Phase I Study. Phase II Dose of the Orally taken Mutant IDH Inhibitor BAY 1436032. Cohorts will consist of patients representing the following IDH1-R132X-mutant intrahepatic cholangioncarcinoma, glioblastoma/ anaplastic glioma
Read MoreMy Pathway: An Open Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
This open-label study is looking at targeted therapies in patients with advanced cancer for whom there is no available, beneficial treatment.
Read MorePhase II study of copanlisib (BAY 80-6946) in combination with gemcitabine and cisplatin in advanced cholangiocarcinoma
This is a study for patients with advanced cholangiocarcinoma or gallbladder cancer. It includes chemotherapy (gemcitabine and cisplatin) with the addition of a PI3K inhibitor to try to improve outcome for this group of patients
Read MoreA Phase II Study of Nivolumab in Patients with Advanced Refractory Biliary Cancers
The purpose of this study is to test the efficacy of the immunotherapy agent nivolumab in patients with advanced, refractory biliary cancers (intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer). Patients will be evaluated for progression-free survival, overall survival and response rate.
Read MoreSTARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors (including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
This study will enroll patients with advanced cancers (including cholangiocarcinoma) that have an NTRK/ROS1/ALK gene rearrangement (also called gene fusions), which may be primary causes of cancer. This study will evaluate if an investigational drug, Entrectinib (also known as RXDX-101), can block the growth of cancer cells caused by NTRK/ROS1/ALK gene rearrangements.
Read MoreStudy of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3
This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions
Read MoreRandomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma
To evaluate the addition of liver-directed radiation therapy to chemotherapy with respect to overall survival (OS) for patients with unresectable, localized intrahepatic cholangiocarcinoma
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