Trials explorer

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Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements is being studied. Conditions: Intrahepatic Cholangiocarcinoma, FGFR2 Gene Mutation, FGFR2 Gene Rearrangement +1 • Eligibility: Inclusion Criteria: Patients who meet all of the following criteria are eligible for trial participation: * Signed informed consent form (ICF). * Patients\*, age ≥ 18 years at…. Goal: The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the safety profile to support the continuation of the concept in a large, randomized trial for further development. Phase/Status/Sponsor: Unknown phase; TERMINATED; Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

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Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements is being studied. Conditions: Advanced Cholangiocarcinoma, FGFR2 Gene Rearrangements • Eligibility: Inclusion Criteria: A participant must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1. Provide written informed consent. 2. Is ≥18…. Goal: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements Phase/Status/Sponsor: Unknown phase; TERMINATED; Taiho Oncology, Inc..

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Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations is being studied. Conditions: Advanced Cholangiocarcinoma, FGFR2 Gene Mutation • Eligibility: Inclusion Criteria: * Histologically or cytologically confirmed unresectable locally advanced or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible * Have written…. Goal: Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Phase/Status/Sponsor: Unknown phase; TERMINATED; QED Therapeutics, a BridgeBio company.

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This is an expanded-access study of TAS-120 for adults with advanced cholangiocarcinoma that has FGFR2 gene rearrangements. The study is for patients who have failed standard therapy or cannot tolerate it and is intended to provide TAS-120 before it is commercially available. Eligibility includes adults 18 and older with confirmed locally advanced, metastatic, or unresectable disease, with measurable or non-measurable lesions, ECOG 0-1, and adequate organ function. Key exclusions include pregnancy or breastfeeding, significant retinal disorders, calcium–phosphorus balance problems, serious illnesses, or other non-tumor-related health conditions.

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- This study tested bemarituzumab in adults whose solid tumors overexpress FGFR2b. - It aimed to assess safety and tolerability and to look for early signs of anti-tumor activity. - Eligible participants had unresectable, locally advanced, or metastatic cancers (such as head and neck squamous cell carcinoma, triple-negative breast cancer, intrahepatic cholangiocarcinoma, lung adenocarcinoma, platinum-resistant ovarian cancer, endometrial or cervical cancer, or other solid tumors) with FGFR2b overexpression and prior therapy. - Exclusions included untreated or symptomatic CNS metastases, certain heart and eye conditions, and prior investigational FGFR pathway inhibitors. - The study status is completed.

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Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma. 3. Subjects diagnosed…. Goal: This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; TransThera Sciences (Nanjing), Inc..

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- This is a phase 2, single-arm, open-label study across multiple centers that tests ICP-192 in people with FGFR2-rearranged intrahepatic cholangiocarcinoma that is unresectable or has spread after prior treatment. - It aims to learn how well ICP-192 works against the cancer and how safe it is. - Eligible participants are adults (18+) with unresectable or metastatic disease, measurable tumors, FGFR2 fusion/rearrangement, and adequate organ function who have progressed after at least one line of chemotherapy. - Key exclusions include prior FGFR-targeted therapy, active CNS metastases, pregnancy or breastfeeding, certain infections or uncontrolled illnesses, and use of drugs that strongly affect CYP3A.

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Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements is being studied. Conditions: Intrahepatic Cholangiocarcinoma • Eligibility: Inclusion Criteria: Patients must meet all of the following criteria to be eligible for the study: 1. Fully informed written consent and locally required authorization (European Union \[EU\]…. Goal: The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

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- This study tested KIN-3248, an oral FGFR inhibitor, in adults with advanced tumors that have FGFR2 and/or FGFR3 gene alterations. - It had two parts: a dose-escalation phase to find a safe, tolerable dose, and a dose-expansion phase to evaluate safety and preliminary efficacy at the recommended dose in FGFR2/FGFR3-altered cancers (including intrahepatic cholangiocarcinoma and urothelial cancer). - The trial looked at safety, tolerability, how the drug behaves in the body (PK/PD), and early signs of anti-tumor activity. - Eligible participants were adults with advanced solid tumors and confirmed FGFR2/FGFR3 alterations, measurable disease, good performance status, and adequate organ function; key exclusions included active brain metastases, certain eye or mineral balance disorders, significant GI issues affecting oral intake, active infections, and pregnancy. - The study status is terminated.

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A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement is being studied. Conditions: Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation • Eligibility: Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent…. Goal: This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Phase/Status/Sponsor: Unknown phase; RECRUITING; Mehmet Akce.

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Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification is being studied. Conditions: Cholangiocarcinoma, Liver Cancer • Eligibility: Inclusion Criteria: 1. Is male or female aged ≥18 years. 2. Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma. 3. Has disease that is measurable per the RECIST…. Goal: To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation. Phase/Status/Sponsor: Unknown phase; WITHDRAWN; M.D. Anderson Cancer Center.

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This trial tests nanvuranlat in adults with biliary tract cancer to find a recommended dose regimen (Part A) and to study its effect on overall survival compared with the physician’s best choice (Part B). Participants are 18 years or older with advanced, metastatic, or unresectable BTC who have received one prior platinum-based therapy. Treatments are given every two weeks with safety checks, tumor imaging, and exploratory tests to understand how the drug works. Key exclusions include active CNS metastases, significant cardiovascular disease, HIV not on therapy, active HBV or HCV infection, and pregnancy.

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Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer is being studied. Conditions: FGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR2 Gene Amplification +5 • Eligibility: Inclusion Criteria: * Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell…. Goal: This phase II/III trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the fibroblast growth factor receptor (FGFR) biomarker. Phase/Status/Sponsor: Unknown phase; COMPLETED; SWOG Cancer Research Network.

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SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry is being studied. Conditions: Cancer, Metastatic, Cancer, Cancer of Pancreas +40 • Eligibility: Inclusion Criteria: * Pts with solid and hematological malignancies; * Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2,…. Goal: International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention. Phase/Status/Sponsor: Unknown phase; RECRUITING; Massive Bio, Inc..

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Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma is being studied. Conditions: Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation +2 • Eligibility: Inclusion Criteria: 1. ≥ 18 years of age, at the time of signing informed consent 2. Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received…. Goal: This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma. Phase/Status/Sponsor: Unknown phase; COMPLETED; TransThera Sciences (Nanjing), Inc..

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Summary not available yet.

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This study tests tinengotinib against a physician's choice treatment in adults with FGFR-altered cholangiocarcinoma that is unresectable or metastatic and has progressed after chemotherapy and an FGFR inhibitor. About 200 participants worldwide will be enrolled and randomized to receive tinengotinib (8 mg or 10 mg daily) or physician's choice to evaluate efficacy and safety. The trial aims to learn whether tinengotinib can improve outcomes compared with standard care in this FGFR-altered, treatment-refractory cancer. Eligibility requires adults 18 and older with FGFR2 fusion/rearrangement who have had at least one prior chemotherapy and one FDA-approved FGFR inhibitor. Key exclusions include having had two or more FGFR inhibitors, active brain/CNS metastases, another active cancer, recent systemic or radiotherapy, and uncontrolled hypertension.

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Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies is being studied. Conditions: Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer +4 • Eligibility: Inclusion Criteria: * Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent to participate in the study must be performed before any procedure's protocol…. Goal: The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies. Phase/Status/Sponsor: Unknown phase; RECRUITING; Celon Pharma SA.

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Summary not available yet.

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Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples is being studied. Conditions: Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma • Eligibility: Inclusion Criteria: * If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use…. Goal: The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples Phase/Status/Sponsor: Unknown phase; COMPLETED; ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

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Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma is being studied. Conditions: Biliary Tract Carcinoma, Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. Age ≥18 years, men and women; 2. ECOG performance status of 0-1; 3. Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one…. Goal: This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer. The study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Eastern Hepatobiliary Surgery Hospital.

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- The trial tests SD-101, a TLR9 agonist, delivered directly to the liver via hepatic artery infusion in adults with hepatocellular carcinoma or intrahepatic cholangiocarcinoma. - It has three groups: SD-101 alone, SD-101 with pembrolizumab, and SD-101 with ipilimumab plus nivolumab, to find safe dose levels and see if adding immune therapy helps. - In Phase 1b, researchers aim to identify the recommended safe dose and which checkpoint inhibitor combination is tolerated; in Phase 2 they will test that dose with single or double immune therapy to assess safety and early effectiveness. - Eligible participants are adults with liver-focused cancer that has progressed after one prior therapy and who have adequate organ function; key exclusions include active brain metastases, active HBV/HCV infection, advanced liver failure, prior SD-101, and history of significant immune-related adverse events.

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Futibatinib in Patients With Specific FGFR Aberrations is being studied. Conditions: Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN) • Eligibility: Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 2. Known FGFR aberration status and tumor type that meet all of the criteria for…. Goal: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma \[iCCA\]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements. Phase/Status/Sponsor: Unknown phase; TERMINATED; Taiho Oncology, Inc..

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- The study tested pemigatinib for people with advanced, metastatic, or surgically unresectable cholangiocarcinoma that has FGFR2 translocations and who have failed at least one prior therapy. - The goal was to learn how effective and safe pemigatinib is in this specific group. - Eligible participants needed confirmed cholangiocarcinoma with measurable disease, FGFR gene alteration status, disease progression after prior therapy, ECOG 0-2, and a life expectancy of at least 12 weeks. - Key exclusions included prior treatment with a selective FGFR inhibitor, history of unwanted calcifications, active corneal or retinal disorders, and use of potent CYP3A4 inhibitors or inducers close to dosing (topical ketoconazole allowed).

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This trial tests pemigatinib versus the standard chemotherapy regimen gemcitabine plus cisplatin as first-line treatment for adults with unresectable or metastatic cholangiocarcinoma that has an FGFR2 rearrangement. It aims to evaluate the efficacy and safety of pemigatinib in this setting. Eligible participants are adults 18 and older with confirmed FGFR2-rearranged cholangiocarcinoma that cannot be surgically removed or has spread, and with good performance status. Key exclusions include prior systemic therapy for unresectable/metastatic disease, Child-Pugh B or C liver disease, active CNS metastases, and significant cardiac disorders.

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Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma is being studied. Conditions: Cholangiocarcinoma, Bile Duct Cancer • Eligibility: Inclusion Criteria: 1. Histologically documented locally advanced or metastatic biliary tract cancer (intra or extrahepatic cholangiocarcinoma or gallbladder cancer) previously treated with first line standard chemotherapy (gemcitabine-based chemotherapy…. Goal: This is a multi-centre, open-label, single arm phase 2 study to assess the efficacy of TRIFLURIDINE/TIPIRACIL, in patients with advanced cholangiocarcinoma as measured by median progression-free survival (PFS). This study will enroll a total of 47 patients over a 12-month period, according to a two stage enrollment design. Phase/Status/Sponsor: Unknown phase; TERMINATED; Sunnybrook Health Sciences Centre.

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A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma is being studied. Conditions: Intrahepatic Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. Voluntary participation and written informed consent; 2. Aged 18-75 years (inclusive), males and females; 3. Those with histopathologically diagnosed iCCA, who had previously undergone but…. Goal: This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy. Phase/Status/Sponsor: Unknown phase; WITHDRAWN; Jiangsu HengRui Medicine Co., Ltd..

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