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.

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ZW25-201: 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.

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HERIZON-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.

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Phase 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…

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Ivosidenib (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.

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CRESTONE: 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.

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A 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.

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NuTIde: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

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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.

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A 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.

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TAS-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.

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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

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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

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…

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A 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).

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A 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…

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Durvalumab 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.

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A 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.

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PROOF 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).

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A 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.

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Tree 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.

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GNS561-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.

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A 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.

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A 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

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ClarIDHy: 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.

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Immunotherapy 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.

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STARTRK-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.

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Study 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

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