NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).

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FIRST-308

This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.

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Effects of Exercise and Nutritional Interventions During Platinum Chemotherapy on Neuropathy: Examining the Interoceptive Brain System and Inflammation

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. There are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN.

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A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer

This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA) that cannot be removed by surgery (unresectable) or that may have spread from where it first started.

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Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors

Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip Code 78229 Country United States List additional…

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Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases

This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).

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TS-PERIO-02 – ACTIVE, NOT RECRUITING

Study Name TS–PERIO–02 ClinicalTrials.gov Identifier (if applicable) NCT05220722 Clinical Trial Category (check all that apply) Beyond First Line Therapy Immunotherapy Other Novel Therapy Study Center Institution Name MD Anderson Cancer Center City Houston State Texas Country United States List additional Institutions (include address, phone number, and website) Rhode Island Hosptial at Brown University of Colorado…

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phase 2 basket trial of ulixertinib (BVD-523) in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations (BVD-523-HCQ)  

This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations. The trial will have five baskets based on disease primary: cholangiocarcinoma, pancreatic, colorectal, esophageal, and gastric adenocarcinomas.

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A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002

Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.

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Brightline-2

This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.

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A Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations

This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam

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A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients with Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

The study drug, ENV-101, acts on a protein in the body that is thought to be involved with the
growth of these abnormal cells caused by a mutation of a gene, PTCH1. By blocking this
process, ENV-101 may slow the progress of the disease or you may have a partial or complete
response.

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ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal 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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Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors

Study Name   Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable)   NCT05275478 Clinical Trial Category (check all that apply)   Beyond First Line Therapy Targeted Therapy Study Center Institution Name   NEXT Oncology Institution Address   2829 Babcock Road City   San Antonio State   Texas Zip…

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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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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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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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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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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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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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