Beyond First Line Therapy
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 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 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 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 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 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 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 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 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 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 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 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 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.
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