[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,106,0,25,[9,47,74,103,126,148,174,209,234,262,300,338,369,399,425,455,474,506,538,568,605,624,651,674,700],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053587","phase-1-combination-of-gns561-and-trametinib-in-patients-with-advanced-kras-mutated-cholangiocarcinoma-100053587",false,"NCT05874414","Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma","Phase 1b\u002F2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma","Inclusion criteria:\n\n1. Histologically confirmed intrahepatic CCA with a documented KRAS mutation.\n2. Patients greater than or equal to 18 years of age.\n3. Patients must have disease progression that is not amenable to potentially curative treatment.\n4. Patients must have received one or two lines of chemotherapy.\n5. Patients must have at least one measurable disease by RECIST v1.1.\n6. Performance status (ECOG) 0-1.\n7. Adequate organ baseline function defined as follows: absolute neutrophil count ≥1000 cells\u002FμL, platelet count ≥75,000 cells\u002FμL, hemoglobin ≥9 g\u002FdL, aspartate aminotransferase or alanine aminotransferase less than or equal to 3 × upper limit of normal, estimated glomerular filtration rate ≥60 mL\u002Fmin, corrected QT interval by Fridericia's (QTcF) interval ≤470 msec.\n8. Women of childbearing potential must present with a negative serum pregnancy test and agree to use adequate contraception during the study and until 6 months after the end of treatment. Male patients with women partners of childbearing potential must agree with the contraception procedures of the study protocol.\n9. Patients must be able to understand and be willing to comply with the requirements of the study protocol.\n10. Patients participate voluntarily and sign informed consent form(s).\n\nExclusion criteria:\n\n1. Previous treatment with a MEK inhibitor or autophagy inhibitor.\n2. Previous treatment with three or more lines of prior chemotherapy.\n3. Extrahepatic CCA with recent (within 6 weeks) placement of a stent or episodes of unstable biliary stents (manifest as obstruction, migration of the stent, infevtion or mechanical failure of the stent) within 6 weeks according to investigator's judgement.\n4. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n   1. Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \\\u003C50%, arrythmias or cardiac conduction abnormalities. Uncontrolled arterial hypertension or inadequately controlled arterial hypertension, at the discretion of the investigator, based on an average of = \\>3 BP readings over = \\>2 sessions.\n   2. Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal pigment epithelial detachment.\n   3. History of interstitial lung disease or pneumonitis.\n   4. Patients who have clinically significant pleural effusion or ascites.\n   5. Patients who have neurological condition (e.g., tremor, ataxia, hypotension, confusion), history of seizures or active central nervous system metastases.\n   6. Impairment of gastrointestinal function or gastrointestinal disease (e.g., diarrhea, active ulcer disease, history of gastrointestinal perforation\u002Fhemorrhage, malabsorption or other conditions that under the judgment of the principal investigator (PI) may impair absorption of study drugs).\n   7. Patients who are taking antineoplastic drugs for concomitant cancer or history of malignancy other than CCA within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n   8. Any other condition that would, in the Investigator s judgment, contraindicate the patients' participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection, unable to swallow medication, social\u002Fpsychological issues, etc).\n5. Known active viral hepatitis, including HBV and HCV.\n6. Patients with known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, mefloquine) and\u002For hypersensitivity to study drugs.\n7. Patients who have not recovered for certain AEs due to previous lines of therpay.\n8. Female patients who are pregnant or lactating at the time of enrollment.","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an open-label, multicenter Phase 1b\u002F2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy",[28],"Cholangiocarcinoma",[30,28,31,32,33],"GNS561","Trametinib","Phase1b\u002F2a","Bile Duct cancer","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2023-08-21",{"date":42,"type":21},"2028-06",{"name":44,"class":45},"Genfit","INDUSTRY",11,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100536139","targeted-navigation-in-hepatocellular-carcinoma-hcc-100536139","NCT06260943","Targeted Navigation in Hepatocellular Carcinoma (HCC)","Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation","Inclusion Criteria:\n\n* HCC Patients:\n\n  * Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.\n  * Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0.\n  * Adults, age 18 or older\n  * Able to provide informed consent\n* All other interviewees:\n\n  * Advocates who will self-identify as having had HCC.\n  * Others who self-identify as either a caregiver or support person of an HCC patient.\n\nPhysicians\u002FLicensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.\n\nExclusion Criteria:\n\n* Unable to speak Spanish or English\n* West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.\n* Adults unable or unwilling to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected",true,{"count":56,"type":21},210,[58],"NA","The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.",[61,28,62],"Hepatocellular Carcinoma","Hepatobiliary Cancer","2026-06-30",{"date":65,"type":38},"2026-07-02",{"date":67,"type":38},"2024-04-15",{"date":69,"type":21},"2026-10-31",{"name":71,"class":72},"University of Miami","OTHER",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":73},"100412023","phase-1-evaluating-efficacy-of-tivozanib-av-951-in-biliary-tract-cancers-100412023","NCT04645160","Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","Phase II Study Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","* INCLUSION CRITERIA:\n\n  1. Participants with histologically or cytologically confirmed biliary tract cancer (BTC) (cholangiocarcinoma or gallbladder cancer). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n  2. Participants must have disease that is not amenable to resection.\n  3. Participants must have had prior treatment with 1st line chemotherapy.\n  4. Disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.\n  5. Age \\>=18 years.\n\n     NOTE: Because no dosing or adverse event data are currently available on the use of tivozanib in participants \\\u003C 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.\n  6. ECOG performance status \\\u003C= 2\n  7. Adequate organ and marrow function as defined below:\n\n     * Hemoglobin \\>= 8.0 g\u002FdL\n     * Absolute Neutrophil Count \\>= 1,000\u002FmcL\n     * Platelets \\>= 75,000\u002FmcL\n     * Total Bilirubin \\\u003C= 2.5 X institutional upper limit of normal (ULN)\n     * AST(SGOT)\u002FALT(SGPT) \\\u003C= 5 X institutional ULN\n     * Creatinine Clearance \\> 30\n     * Serum Albumin (g\u002FL) \\> 28\n  8. Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP), excepting identified false-positive pregnancy test results as permitted in the note below.\n\n     NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n     NOTE: Advanced biliary tract disease may secrete hormones that produce false-positive pregnancy test results. A false-positive result will be explicitly determined in this protocol at screening via a series of serial blood tests (i.e., serum HCG measurements) over a 5-day period (i.e., a minimum of a blood test on the first and fifth day of the 5-day period), in which a false-positive result not compatible with pregnancy will be defined as results indicating a consecutive, clinically low, constant level (i.e., no more than a 15% rate of increase) of HCG over the testing period. An ultrasound may be performed for clarification purposes as necessary.\n  9. All participants (regardless of childbearing potential) must (all) agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 1 month after completion of treatment.\n  10. Ability of participant to understand and the willingness to sign a written informed consent document.\n  11. Ability and willingness to co-enroll on the tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n\nEXCLUSION CRITERIA:\n\n1. Chemotherapy, small molecule or radiation therapy within 2 weeks prior to administration of first dose of study drug.\n2. Prior treatment with Tivozanib.\n3. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy).\n4. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.\n5. Previous malignant disease other than the target malignancy within the last 3 years with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, chronic lymphocytic leukemia, or thyroid carcinoma.\n6. Current active second primary malignancy, other than skin carcinoma (basal or squamous cell carcinoma), chronic lymphocytic leukemia not requiring active treatment, or differentiated thyroid carcinoma.\n7. History of allergic reactions or known or suspected hypersensitivity attributed to compounds of similar chemical or biologic composition to tivozanib.\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy (see exceptions below), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n\n   * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n   * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable and on suppressive therapy, if indicated. For participants with HBV infection who are currently on treatment, they are eligible if they have an undetectable HBV viral load.\n   * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n9. Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 3 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.\n10. Uncontrolled hypertension, i.e., blood pressure (BP) of \\>= 150\u002F90 mmHg; participants who have a history of hypertension controlled by medication must be on a stable dose of antihypertensive therapy such that there has been no increase in hypertensive medications or dosage (for at least -14 days) and meet all other inclusion criteria.\n11. Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.\n12. GI Bleeding (e.g., esophageal varices or ulcer bleeding) within 3 months. (Note: For participants with a history of GI bleeding for more than 12 months or assessed as high risk for esophageal variceal by the Investigator, adequate endoscopic therapy according to institutional standards is required.)\n13. Complex biliary obstruction requiring bile duct stents at more than one level of the biliary tree or external biliary drainage.\n14. Recurrent episodes of cholangitis (\\>1) in the preceding 3 months prior to enrollment.\n15. Therapeutic anti-coagulation or anti-platelet therapy with the exception of low molecular weight heparin, aspirin, or factor Xa inhibitors.\n16. Pregnant or lactating individuals. Pregnant individuals are excluded from this study because based on findings in animals and its mechanism of action, tivozanib can cause fetal harm when administered to a pregnant individual. In animal reproduction studies, administration of tivozanib to pregnant rats caused adverse developmental outcomes including embryo- fetal mortality. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the individual with tivozanib, nursing (such as breastfeeding) should be discontinued if the individual is treated with tivozanib. These potential risks may also apply to other agents used in this study.",{"count":82,"type":21},31,[24,25],"Background:\n\nCholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth.\n\nObjective:\n\nTo find the safest and most effective dose of tivozanib to treat CCA and learn its overall response rate.\n\nEligibility:\n\nAdults ages 18 and older with CCA not removable with surgery and have been treated with at least one type of chemotherapy.\n\nDesign:\n\nParticipants will be screened with the following:\n\n* Medical history\n* Physical exam\n* Assessment of their ability to do daily activities\n* Medicine review\n* Blood tests, including thyroid function tests\n* Urine tests\n* Electrocardiogram, to check heart function\n* Pregnancy test, if needed\n* Tumor biopsy, if needed\n* Computed tomography scans\n* Magnetic resonance imaging, if needed\n\nSome screening tests may be repeated during the study.\n\nParticipants will be asked to enroll in protocol #13C0176. This will allow any remaining tumor or blood samples to be used in future research.\n\nParticipants will take tivozanib by mouth, once a day for 21 days per cycle or every other day per cycle. Each cycle is 28 days. They can take the drug until they have bad side effects, their CCA gets worse, or if they become pregnant. They will record their blood pressure twice daily at home. They will also keep a medication diary of each dose of tivozanib they take and any side effects.\n\nParticipants will have study visits before starting each new cycle and every 8 weeks. They will also have a follow-up visit 30 days after treatment ends at NIH, or if they are unable to come to NIH by phone, videocall, or other NIH-approved platform. Then they will be contacted 6 and 12 months later, and then once a year.",[28,86,87],"Bile Duct Neoplasm","Biliary Tract Malignancy",[89,90,91,92,93],"CCA","FOTIVDA","pan-vascular endothelial growth factor receptor (VEGFR) inhibitor","XPO7","Ste-20 like kinase (SLK)","2026-06-27",{"date":63,"type":38},{"date":97,"type":38},"2022-03-04",{"date":99,"type":21},"2029-12-31",{"name":101,"class":102},"National Cancer Institute (NCI)","NIH",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100562756","ivosidenib-in-locally-advanced-or-metastatic-cholangiocarcinoma-with-idh1-r132-mutation-after-at-least-one-prior-systemic-treatment---an-observational-study-100562756","NCT06607302","Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study","Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective, Multicenter, Observational Study in Germany","IDHIRA","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test\n* Patients must have at least one prior systemic therapy\n* Decision for treatment with ivosidenib according to current SmPC.\n* Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module)\n* For patients participating in the PRO module (optional):\n\n  * Dated signature of informed consent form before start of study treatment.\n  * Willingness and capability to participate in PRO assessment in German language.\n* Other criteria according to current SmPC.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period.\n* Other contraindications according to current SmPC.",{"count":112,"type":21},100,"OBSERVATIONAL","Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.\n\nThe prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.",[28],"2026-06-24",{"date":118,"type":38},"2026-06-25",{"date":120,"type":38},"2024-10-08",{"date":122,"type":21},"2027-12",{"name":124,"class":45},"iOMEDICO AG",13,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":73},"100644764","phase-2-18fftt-positron-emission-tomographycomputed-tomography-to-predict-treatment-response-in-patients-scheduled-to-receive-gemcitabine-cisplatin-and-durvalumab-for-newly-diagnosed-cholangiocarcinoma-100644764","NCT07673341","[18F]FTT Positron Emission Tomography\u002FComputed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma","Imaging PARP Expression in Cholangiocarcinoma","Inclusion Criteria:\n\n* Patient must have histologically confirmed cholangiocarcinoma\n* Patient must be newly diagnosed and have not yet been treated\n* Patient planned to receive GCD per standard-of-care\n* Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1\n* Age ≥ 18 years\n* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \\[18F\\]FTT PET imaging\n* Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures\n* Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":134,"type":21},22,[25],"This phase II trial studies whether \\[18F\\]FTT can be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET\u002FCT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, \\[18F\\]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. \\[18F\\]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET\u002FCT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using \\[18F\\]FTT with PET\u002FCT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.",[28],"NOT_YET_RECRUITING","2026-06-22",{"date":141,"type":38},"2026-06-29",{"date":143,"type":21},"2026-11-01",{"date":145,"type":21},"2028-12-31",{"name":147,"class":72},"University of Washington",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100580714","phase-1-a-study-of-phst001-in-advanced-solid-tumors-100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":156,"type":21},272,[24],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[160,161,162,28,163],"Advanced Solid Tumors","Ovarian Cancer","Endometrial Cancer","CNS Tumor","2026-06-18",{"date":166,"type":38},"2026-06-23",{"date":168,"type":38},"2025-03-31",{"date":170,"type":21},"2031-04",{"name":172,"class":45},"Pheast Therapeutics",20,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":73},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",{"count":182,"type":21},70,[58],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[186,187,188,189,190,191,192,193,194,195,196,197,198,199,28,200],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Colorectal Adenocarcinoma","2026-06-17",{"date":164,"type":38},{"date":201,"type":38},{"date":205,"type":21},"2028-07",{"name":207,"class":208},"University Hospital, Angers","OTHER_GOV",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":216,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":219,"conditions":220,"keywords":225,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":4,"leadSponsor":233,"locationsCount":73},"100202701","obtaining-solid-tumor-tissue-from-people-having-biopsy-or-surgery-for-certain-types-of-cancer-100202701","NCT01915225","Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer","Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors","* INCLUSION CRITERIA:\n* Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \\\u003C 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \\[clinically indicated\\] resected tumor tissue) does not add risk to the clinically indicated procedures.\n* Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological\u002Fcytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and\u002For follow-up.\n* Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.\n* Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.\n* Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.\n* Ability of participant, parent\u002Fguardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone.","2 Years",{"count":218,"type":21},1800,"Background:\n\n\\- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).\n\nObjectives:\n\n\\- To collect tissue samples for use in studying new ways to treat tumors.\n\nEligibility:\n\n* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.\n* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.\n\nDesign:\n\n* Before their procedure, participants will have a small blood sample taken.\n* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.\n* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.\n* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.",[221,222,28,223,224],"Colorectal Neoplasms","Gastric Neoplasms","Bile Duct Cancer","Pancreas Cancer",[226,227,228,229],"Tissue Procurement","Surgery","Metastasectomy","Natural History",{"date":164,"type":38},{"date":232,"type":38},"2013-07-21",{"name":101,"class":102},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":73},"100635870","suprapapillary-metal-stent-vs-routine-transpapillary-drainage-in-malignant-hilar-biliary-obstruction-smart-b-trial-100635870","NCT07558304","Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)","Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction","SMART-B","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.\n3. Total bilirubin \\> 3 mg\u002FdL.\n4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.\n5. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:\n\n5.1 Estimated future liver remnant \\\u003C40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.\n\n5.2 Prolonged jaundice with total bilirubin \\>10 mg\u002FdL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin \\\u003C3 g\u002FdL, presumably attributable to cholestasis.\n\n5.4 Indication for neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.\n2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).\n3. Acute cholangitis, clinically defined as fever (axillary temperature \\>38°C) and leukocytosis (white blood cell count \\>10,000\u002Fmm³).\n4. Uncorrectable coagulopathy.\n5. Iodinated contrast allergy not amenable to desensitization.",{"count":243,"type":21},84,[58],"Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.\n\nThere are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.\n\nCurrently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.\n\nThe purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.",[28,247,248],"Bile Duct Neoplasms","Malignant Biliary Obstruction",[28,250,251,252,253,248],"Percutaneous biliary drainage","Self-expanding metal stent","Suprapapillary drainage","Malignant hilar biliary obstruction","2026-06-12",{"date":256,"type":38},"2026-06-16",{"date":258,"type":21},"2026-06-15",{"date":145,"type":21},{"name":261,"class":72},"Hospital de Clinicas de Porto Alegre",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":282,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":73},"100461298","phase-2-pds01adc-in-combination-with-hepatic-artery-infusion-pump-haip-and-systemic-therapy-for-subjects-with-metastatic-colorectal-cancer-intrahepatic-cholangiocarcinoma-or-metastatic-adrenocortical-carcinoma-100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.","120 Years",{"count":182,"type":21},[25],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[274,275,276,221,197,28,247,223,277,278,279,280,281],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[283,284,285,286,287,288,289,290,291,292],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-06-09",{"date":295,"type":38},"2026-06-10",{"date":297,"type":38},"2022-10-24",{"date":145,"type":21},{"name":101,"class":102},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":317,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":73},"100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684","NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.",{"count":309,"type":21},30,[24,25],"This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[28,313,314,315,316],"Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma","Biliary Tract Cancer",[318,319,320,321,322,323,324,325,326,327,328],"CAR-NK","dual-target cell therapy","HER2","ERBB2","CEA","CEACAM5","cholangiocarcinoma","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","2026-06-06",{"date":331,"type":38},"2026-06-11",{"date":333,"type":38},"2026-03-02",{"date":335,"type":21},"2028-10-17",{"name":337,"class":45},"Beijing Biotech",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":347,"type":21},227,[25],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[351,352,353,354,198,28,355,221,356,357,358],"Uterine Cervical Neoplasms","Triple Negative Breast Neoplasms","Prostatic Neoplasms","Squamous Cell Carcinoma of Head and Neck","Gallbladder Neoplasms","Pancreatic Ductal Adenocarcinoma","Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","2026-06-04",{"date":361,"type":38},"2026-06-08",{"date":363,"type":21},"2026-06-02",{"date":365,"type":21},"2029-08-15",{"name":367,"class":45},"GV20 Therapeutics",2,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":380,"conditions":381,"keywords":385,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":368},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":377,"type":21},16,[379],"PHASE4","A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[382,383,28,384],"AML (Acute Myeloid Leukemia)","Glioma","Solid Tumor Malignancies",[386,387,388,389],"IDH1 Mutation","Hematology and Oncology","Oncology","Drug-Drug Interactions","2026-06-03",{"date":392,"type":38},"2026-06-05",{"date":394,"type":38},"2026-02-23",{"date":396,"type":21},"2027-06-30",{"name":398,"class":45},"Rigel Pharmaceuticals",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100612945","phase-2-phase-ii-study-evaluating-ivosidenib-maintenance-after-soc-adjuvant-chemotherapy-in-curative-midh1-cholangiocarcinoma-100612945","NCT07260175","Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO - A Phase II Trial of Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO","Inclusion Criteria:\n\n1. Patient\\* provides signed informed consent.\n2. Patient is ≥ 18 years at the time of given informed consent.\n3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)\n4. Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 dPCR)\n5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.\n6. Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion).\n7. Patient has ECOG Performance status ≤ 1\n8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.\n9. Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin \u002F Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific.\n10. Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program.\n11. Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.\n12. Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Patient has a metastatic or R+ resected biliary tract cancer.\n2. Patient received previous therapy with an IDH1 inhibitor.\n3. Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.\n4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.\n5. Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control).\n6. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.\n7. Patient has known allergic \u002F hypersensitive reactions to at least one of the treatment components.\n8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.\n9. Patient has a known presence of an active, uncontrollable infection.\n10. Patient has QTc \\> 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored).\n11. Patient has active disseminated intravascular coagulation.\n12. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n13. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.\n14. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing.\n15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.\n16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.",{"count":408,"type":21},40,[25],"This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma",[28,412],"IDH Mutation",[414,415,324,416],"mIDH1 cholangiocarcinoma","ivosidenib maintenance","R0-resection",{"date":359,"type":38},{"date":419,"type":38},"2025-11-18",{"date":421,"type":21},"2031-12",{"name":423,"class":72},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest",12,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":443,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":309},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":434,"type":21},241,[24],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[438,439,440,221,441,442,28],"Ovarian Neoplasms","Breast Neoplasms","Pancreatic Intraductal Neoplasms","Esophageal Neoplasms","Stomach Neoplasms",[444,445,446,447],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP",{"date":359,"type":38},{"date":450,"type":38},"2025-10-22",{"date":452,"type":21},"2033-03",{"name":454,"class":45},"Eli Lilly and Company",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":465,"studyType":113,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":73},"100401706","liver-cancer-registry-platform-100401706","NCT04510740","Liver Cancer Registry Platform","JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer","JADE","Inclusion criteria:\n\n* Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced\u002Fmetastatic stage\n* Age ≥ 18 years\n* Signed and dated informed consent (IC):\n\n  * For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment\n  * For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment\n\nExclusion criteria:\n\nPatients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)",{"count":464,"type":21},1000,"3 Years","The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.",[468,28],"Hepatocellular Carcinoma (HCC)",{"date":359,"type":38},{"date":471,"type":38},"2020-08-09",{"date":122,"type":21},{"name":124,"class":45},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":480,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":481,"phases":4,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":501,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":502,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":503,"locationsCount":505},"100405976","expanded-access-to-ulixertinib-bvd-523-in-patients-with-advanced-mapk-pathway-altered-malignancies-100405976","NCT04566393","Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies","Inclusion Criteria:\n\n* Main Inclusion Criterion:\n\n  1\\. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.\n* Other Inclusion Criteria:\n\n  1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.\n  2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1\n  3. Male or female patients aged ≥ 12 years.\n  4. Patient must be able to swallow and retain orally administered medication.\n\n     Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.\n  5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.\n  6. Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.\n  7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant\n  8. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.\n\nExclusion Criteria:\n\n1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.\n3. Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.\n4. A history of current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.\n7. Known hypersensitivity to ulixertinib or any component in its formulation.\n8. Patients taking prohibited medications as described in current Investigator's Brochure.\n\n   Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks.\n9. Patient is actively breastfeeding.\n10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.","12 Years","EXPANDED_ACCESS","The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.\n\nUlixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.",[484,485,197,486,487,488,489,490,491,492,28,161,61,493,494,495,496,497,498,499,500],"Pancreatic Cancer","Small Bowel Cancer","Melanoma","Non Small Cell Lung Cancer","Thyroid Cancer","Bladder Cancer","Head and Neck Cancer","Gastric Cancer","Esophageal Cancer","Glioblastoma","MAPK Gene Mutation","KRAS Activating Mutation","BRAF Gene Mutation","NRAS Gene Mutation","HRAS Gene Mutation","MEK Mutation","ERK Mutation","AVAILABLE",{"date":359,"type":38},{"name":504,"class":45},"xCures",26,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":517,"conditions":518,"keywords":527,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":73},"100581542","phase-2-trop2-targeted-immunopet-imaging-of-solid-tumors-100581542","NCT06851663","Trop2-targeted immunoPET Imaging of Solid Tumors","Inclusion Criteria:\n\n* Aged 18-75 year-old and of either sex\n* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;\n* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n* Pregnancy；\n* Severe hepatic and renal insufficiency;\n* Allergic to single-domain antibody radiopharmaceuticals.","75 Years",{"count":514,"type":21},400,[25,516],"PHASE3","This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography\u002Fcomputed tomography (immunoPET\u002FCT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.",[519,520,521,489,522,523,524,525,28,161,526,162,488,490],"Solid Tumor","Solid Carcinoma","Uroepithelial Carcinoma","Prostate Cancer","Lung Cancer","Nasopharyngeal Cancer","Liver Cancer","Cervical Cancer",[528,529,519],"Trophoblast cell surface antigen 2 (Trop2)","ImmunoPET","2026-05-27",{"date":532,"type":38},"2026-05-29",{"date":534,"type":38},"2024-12-23",{"date":122,"type":21},{"name":537,"class":72},"RenJi Hospital",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":546,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":4},"100640173","eyemax-versus-spyglass-ds-for-biliary-stricture-diagnosis-100640173","NCT07620080","EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis","Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS","EYE\u002FSPY","Inclusion Criteria:\n\n* 1\\. Adult patients aged 18 to 84 years\n* 2\\. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture\n* 3\\. Absence of a mass easily accessible to EUS-guided fine needle aspiration\n* 4\\. ASA physical status 1-3\n* 5\\. No participation in another clinical trial\n* 6\\. Written informed consent obtained\n* 7\\. Patient affiliated with a social security system or equivalent\n\nExclusion Criteria:\n\n* 1\\. Lithiasic biliary obstruction\n* 2\\. Patients younger than 18 years\n* 3\\. ASA 4 or ASA 5 patients\n* 4\\. Pregnant or breastfeeding women\n* 5\\. Coagulation disorders preventing biopsy procedures\n* 6\\. Surgical anatomy preventing papillary access\n* 7\\. Patients unable to provide informed consent\n* 8\\. Upper gastrointestinal obstruction\n* 9\\. Intolerance to endoscopy\n* 10\\. Severe cardiopulmonary disease\n* 11\\. Acute pancreatitis or severe cholangitis\n* 12\\. Severe contrast agent allergy\n* 13\\. Patients under legal protection measures","84 Years",{"count":548,"type":21},120,[58],"Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.\n\nThe EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.\n\nThe primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.",[28,552],"Biliary Stricture",[554,555,556,557,558,559],"Cholangioscopy","ERCP","EYEMAX","SpyGlass DS","Biliary biopsy","Cholangiocarcinoma diagnosis","2026-05-26",{"date":363,"type":38},{"date":563,"type":21},"2026-09",{"date":565,"type":21},"2030-09",{"name":567,"class":72},"David KARSENTI",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":581,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":73},"100401235","tcf-001-track-target-rare-cancer-knowledge-study-100401235","NCT04504604","TCF-001 TRACK (Target Rare Cancer Knowledge) Study","TRACK","INCLUSION CRITERIA\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study related blood draws and assessments for the duration of the study.\n* Individuals who are 18 years old or older at the time of consent.\n* Patients with a rare (fewer than 6 cases per 100,000 per year) solid tumor or lymphoma with evaluable disease at baseline. The complete list of included cancers are included in the study protocol; diseases not listed in the study protocol may be enrolled with the approval of the Principal Investigator.\n* May or may not have had qualifying (by Foundation Medicine) comprehensive genomic profiling before the present study. For those who have had qualifying comprehensive genomic profiling performed prior to the present study, the archival specimen tested must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study.\n* Willingness to provide existing archived and\u002For newly collected tissue resulting from standard of care procedures and blood samples for genomic profiling. If the submitted sample is determined to be insufficient for testing, the patient will be considered to be a screen failure.\n* For archival tissue to be used for comprehensive genomic profiling for the present study, that specimen must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study.\n* Willingness to provide clinical and medical information to the study team as required.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Ability to read, write and communicate in English.\n* Ability to review and sign a web-based informed consent form, or review and sign an informed consent form in treating physician office.\n* Resides within the United States.\n\nEXCLUSION CRITERIA\n\n* Participants who are unable to provide informed consent.\n* Participants who are 17 years of age or younger.\n* Participants who are unable to comply with the study procedures.\n* Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.\n* Concurrent active malignancy requiring treatment within 1 year of enrollment, at the discretion of treating physician.\n* Pregnancy or breastfeeding.\n* Any unlisted criteria at the discretion of the treating physician.",{"count":514,"type":21},[58],"This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.",[579,28,580],"Rare Cancers","Cancer of Unknown Primary Site",[582,583,584,585,586,587,588,589,590,591,592,593,594,595,596],"genomics","precision medicine","molecular tumor board","remote participation","targeted therapy","patient reported outcomes","understudied diseases","comprehensive genomic profiling","virtual","next generation sequencing","liquid biopsies","tumor biopsies","cell-free DNA","biomarker testing","solid tumors","2026-05-21",{"date":560,"type":38},{"date":600,"type":38},"2020-10-01",{"date":602,"type":21},"2028-12",{"name":604,"class":72},"TargetCancer Foundation",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":622,"locationsCount":4},"100637737","phase-2-study-of-becotatug-vedotin-added-to-standard-treatment-for-advanced-bile-duct-cancer-with-egfr-mutations-100637737","NCT07598318","Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations","A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced\u002FMetastatic EGFR-Mutated Biliary Tract Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years old, both genders are eligible.\n* Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure), and at least one assessable lesion.\n* IHC test is positive for EGFR.\n* ECOG PS score 0-1, normal major organ functions, no severe abnormalities in blood, heart, lungs, liver, kidneys, bone marrow and immune deficiency diseases.\n* For female participants of childbearing age, a pregnancy test (serum\u002Furine) result must be negative within 14 days before enrollment, and they must voluntarily use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; for male participants, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug.\n* Expected good compliance, able to follow up on efficacy and adverse reactions as per the protocol requirements.\n* Voluntary participation in this study and signing the informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, their guardian should act on their behalf in the informed process and sign the informed consent form. If the participant is unable to read the informed consent form (such as illiterate participants), a witness should witness the informed process and sign the informed consent form.\n\nExclusion Criteria:\n\n* Within the 3 months prior to enrollment, the participant has not participated in any other clinical studies.\n* Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); Has completely recovered from childhood asthma and does not require any intervention after adulthood or vitiligo can be included, but patients requiring bronchodilators for medical intervention are not included.\n* Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infected individuals.\n* Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinical significance of supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Had severe infection within 4 weeks before the first medication (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever \\> 38.5℃ during screening or before the first administration.\n* Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Had vaccination with attenuated live vaccines within 4 weeks before the first administration or planned during the study period.\n* Has had or is currently suffering from other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer).\n* Has known allergies to any study drug.\n* Pregnant or lactating women, or subjects with reproductive capacity who are unwilling to take effective contraceptive measures.\n* Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc.\n* Other situations that the investigator deems unsuitable for inclusion in this study. Such as: the patient has central nervous system metastasis, has severe laboratory test abnormalities, is accompanied by family or social factors, which may affect the safety of the subject or the collection of data\u002Fsamples.",{"count":613,"type":21},164,[25,516],"This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.",[28],"2026-05-17",{"date":619,"type":38},"2026-05-20",{"date":619,"type":21},{"date":145,"type":21},{"name":623,"class":72},"Sir Run Run Shaw Hospital",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":639,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":73},"100554750","phase-2-18f-fibroblast-activation-protein-inhibitor-18ffapi-74-pet-imaging-for-cancer-detection-100554750","NCT06503146","18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection","* INCLUSION CRITERIA:\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma\u002Fparaganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.\n* Participants must be scheduled or intended to receive treatment for their cancer.\n* Evaluable disease\n* \\>= 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) performance score \\\u003C= 2.\n* Individuals of child-bearing potential (IOCBP) and individuals that can father children must agree to use effective contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 2 months after each (18F) FAPI-74 imaging. Sperm may not be frozen or donated within the same period.\n* Must be willing to discontinue breastfeeding for 2 months after each study imaging.\n* The ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to \\[18F\\]FAPI-74 or other agents used in the study.\n* History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.\n* Weight \\> 350 lbs., or inability to fit within the imaging gantry.\n* Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness\u002Fsocial situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.\n* Serum creatinine \\> 2 times the upper limit of normal.\n* Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.",{"count":631,"type":21},320,[25],"Background:\n\nFibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \\[18F\\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \\[18F\\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.\n\nObjective:\n\nTo see if \\[18F\\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers.\n\nEligibility:\n\nPeople aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma\u002Fparaganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer.\n\nDesign:\n\nParticipants will have 2 baseline scans: an \\[18F\\]FAPI-74, and the approved tracer \\[18F\\]-FDG.\n\nThe \\[18F\\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging.\n\nWithin 1 week, participants will undergo the same scanning procedures with the approved tracer.\n\nIf the baseline scan with \\[18F\\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \\[18F\\]FAPI-74 scan. If \\[18F\\]-FAPi PET scan shows no tumor(s), scans will not be repeated.\n\nIf the participant's cancer progresses within 2 years, scans may be repeated.\n\nFollow-up calls will continue for 2 years.",[635,636,637,638,356,161,61,491,28,489],"Sarcoma","Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)","Mesothelioma","Pheochromocytoma\u002FParaganglioma (PPGL)",[640,641,642],"Fluorodeoxyglucose F18","PET Imaging","18F-Fibroblast Activation Protein Inhibitor","2026-05-16",{"date":645,"type":38},"2026-05-19",{"date":647,"type":38},"2025-09-09",{"date":649,"type":21},"2030-06-01",{"name":101,"class":102},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":673},"100394880","phase-1-bold-100-in-combination-with-folfox-for-the-treatment-of-advanced-solid-tumours-100394880","NCT04421820","BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours","A Phase 1b\u002F2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Be 18 years or older.\n2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.\n3. Histologically and\u002For cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting.\n4. Have measurable disease according to RECIST v1.1.\n5. Have an anticipated survival of at least 16 weeks.\n6. Be ambulatory, with an ECOG performance score of 0 or 1.\n7. Have adequate organ function.\n8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.\n9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF).\n10. (ARM VII): BRAF wild-type tumour status.\n\nExclusion Criteria:\n\n1. Neuropathy \\> grade 2\n2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.\n3. Cerebrovascular accident within the past 6 months before the start of treatment.\n4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.\n5. Any serious medical conditions that might be aggravated by treatment or limit compliance.\n6. Any history of serious cardiac illness.\n7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.\n8. Any other known malignancy within 3 years before the start of treatment.\n9. Active gastrointestinal tract disease with malabsorption syndrome.\n10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.\n11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.\n12. Recent history of weight loss \\> 10% of current body weight in past 3 months before the start of treatment.\n13. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.\n14. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.\n15. Currently breastfeeding\n16. Dihydropyrimidine Dehydrogenase (DPD) deficiency\n17. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)\n18. (ARM VII): Prior exposure to BOLD-100\n19. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours\n20. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)",{"count":659,"type":21},220,[24,25],"BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.",[197,484,663,28],"Gastric Cancers","2026-05-15",{"date":666,"type":38},"2026-05-18",{"date":668,"type":38},"2020-08-28",{"date":670,"type":21},"2026-09-01",{"name":672,"class":45},"Bold Therapeutics, Inc.",24,{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":22,"phases":683,"briefSummary":684,"conditions":685,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":73},"100635787","18f-t2-petct-imaging-for-caix-positive-solid-tumors-100635787","NCT07557225","18F-T2 PET\u002FCT Imaging for CAIX Positive Solid Tumors","Evaluation of Diagnostic Value of 18F-T2 PET\u002F CT Imaging for Tumors Likely to Express High Levels of CAIX","Inclusion Criteria:\n\nAll participants must meet the following criteria:\n\n1. Written and voluntarily given Informed Consent.\n2. Male or female ≥18 years of age at time of consent.\n3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.\n4. Participants with histologically confirmed or suspected tumors of the following types, but not limited to:\n\nClear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.\n\nExclusion Criteria:\n\nParticipants will be excluded from participation in the study if one or more of the following criteria are met:\n\n1. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.\n2. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.\n3. Be a female who is pregnant or breastfeeding.",{"count":682,"type":21},200,[58],"The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET\u002FCT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.",[686,687,197,526,161,490,468,28,487,688,689,484,162,690],"Clear Cell Renal Cell Cancer (ccRCC)","Urothelial Carcinoma (UC)","Small Cell Lung Cancer","Breast Cancer","Von Hippel Lindau Disease","2026-05-12",{"date":693,"type":38},"2026-05-14",{"date":695,"type":38},"2026-04-27",{"date":697,"type":21},"2029-03",{"name":699,"class":72},"Peking University First Hospital",{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":4,"eligibilityCriteria":706,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":707,"targetDuration":4,"studyType":22,"phases":708,"briefSummary":709,"conditions":710,"keywords":714,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":715,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":720,"locationsCount":73},"100539344","phase-1-pemigatinib--afatinib-in-advanced-refractory-solid-tumors-100539344","NCT06302621","Pemigatinib + Afatinib in Advanced Refractory Solid Tumors","A Phase Ia\u002FIb Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors","Inclusion Criteria:\n\nAll Patients\n\n* Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator.\n* FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined by testing routinely performed at a Clinical Laboratory Improvement Amendments (CLIA) or other similarly certified laboratory. If the FGFR alteration is present on circulating tumor DNA (ctDNA) analysis alone, the patient may be eligible with principal investigator approval. Additional mutations may be considered with principal investigator approval.\n* Eastern Cooperative Oncology Group (ECOG) 0-1.\n* At least 18 years of age.\n* Ability to swallow tablets.\n* Life expectancy \\>\u002F=3 months\n* Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.\n* Patients with cholangiocarcinoma must have adequate biliary drainage (per investigator's discretion), with no evidence of ongoing infection.\n* Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.\n* Measurable or non-measurable disease as determined by RECIST 1.1.\n* Adequate organ function defined as:\n\n  * ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases\n  * Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN\n  * Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin\n  * Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL)\n  * Absolute Neutrophil Count ≥ 1.5 x 109\u002FL\n  * Platelets ≥ 75 x 109\u002FL\n  * INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy\n  * NOTE: Transfusions to increase a patient's hemoglobin level or initiation of erythropoietin or G-CSF therapy to meet enrollment criteria are not allowed in the 14 days preceding the first dose of study drug. If a patient receives transfusions, erythropoietin, or G-CSF therapy ≥ 14 days prior to the first dose, the hematologic criteria listed above must be met following the 14-day window and prior to the first dose of study therapy\n\nDose expansion cohort 1: Patients should fulfill the eligibility criteria above for all patients in addition to the following:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma\n* No prior treatment with a selective FGFR inhibitor treatment\n* FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion on tumor profiling in tumor tissue as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval.\n* An archived tumor tissue sample is available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval.\n\nDose expansion cohort 2: Patients should fulfill the eligibility criteria above for all patients in addition to the following:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma\n* Prior FGFR inhibitor treatment at any time prior to treatment start is required\n* FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy, as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval\n* An archived tumor tissue sample after progression on or intolerance of prior FGFR inhibitor available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval.\n\nExclusion Criteria:\n\n* Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib\n* For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs; activating mutations in the FGFR2 kinase domain seen on ctDNA or biopsy analysis prior to the 8-week timepoint may be allowed after discussion with the study PI.\n* Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib and afatinib.\n* Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful adverse events (AEs) can be made with input from the principal investigator.\n* Major surgery within 4 weeks prior to planned start of pemigatinib and afatinib (tumor biopsy, biliary stent or catheter placement, and feeding tube placement are not considered major surgical procedures).\n* Received prior palliative non-CNS radiation within 2 weeks or extended-field radiation administered within 4 weeks of first dose of study drug. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Fibrotic pulmonary disease from prior radiotherapy is permissible with approval of the study PI.\n* Known pre-existing interstitial lung disease\n* Current hypovitaminosis D requiring supraphysiologic (eg 50,000 IU\u002Fweekly) to replenish the deficiency. Vitamin D supplements are allowed.\n* History and\u002For current evidence of clinically significant ectopic mineralization\u002Fcalcification or non-tumor related alteration of calcium-phosphorus homeostasis.\n* History and\u002For current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmological examination\n* Child-Pugh B and C cirrhosis\n* Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator. This includes significant or recent gastrointestinal disorders with diarrhea as a major symptom\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.\n* Patients with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone (GnRH) or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or hormonal therapy in breast cancer\n* Have history of hepatic encephalopathy of any grade\n* Patients with ascites requiring serial paracenteses\n* Active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate provided that they are stable for ≥ 2 months. Patients with suspected or confirmed leptomeningeal disease are not eligible even if treated. Patients with glioblastoma multiforme (GBM) are not eligible.\n* Clinically significant, active cardiovascular disease such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, or history of myocardial infarction within 6 months prior to planned start of pemigatinib and afatinib\n* Fridericia's corrected QT interval (QTcF) \\> 480 ms on ECG conducted during Screening, or history of torsades de pointes or personal or family history of prolonged QT syndrome.Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and the sponsor-investigator makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.\n* Active hepatitis B virus (HBV)\n\n  \\-- Note: Controlled (treated) hepatitis will be allowed if they meet the following criteria: antiviral therapy for HBV must be given for at least 1 month prior to first dose of study drug, and HBV viral load must be less than 2000 IU\u002Fml (104 copies\u002Fml) prior to the first dose of study drug. Those on active HBV therapy with viral loads under 2000 IU\u002Fml (104 copies\u002Fml) should stay on antiviral therapy throughout the study treatment.\n* Known human immunodeficiency virus (HIV) and on anti-retroviral therapy for HIV(excluded due to potential drug-drug interactions between anti-retroviral medications and study treatment but HIV itself is not an exclusion).\n* Known or suspected active drug or alcohol use\n* Concomitant treatment with known strong p-gp inhibitor.\n* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n\n  \\-- Note: Moderate CYP3A4 inhibitors are not prohibited\n* Pregnancy during the study or within 30 days of the last dose of study intervention. Also excluded are any persons of childbearing potential, including men who are able to father a child, who are unwilling to use a medically acceptable method of contraception during the trial (see below section 3.3). Lactation and breastfeeding during the study or within 30 days of the last dose of study intervention is also not allowed. Female patients must have a negative pregnancy test (B-HCG test in urine or serum) prior to commencing study treatment.\n* Unable to swallow pills\n* Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug. Patients unable or deemed by the investigator as unlikely to comply with the protocol are also excluded.",{"count":182,"type":21},[24],"This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.\n\nThe study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.\n\nThis research study involves the study drugs Afatinib and Pemigatinib.",[711,712,713,28],"Advanced Solid Tumor","Unresectable Solid Tumor","Metastatic Solid Tumor",[711,712,713,28],{"date":664,"type":38},{"date":717,"type":38},"2024-04-17",{"date":719,"type":21},"2027-12-01",{"name":721,"class":72},"Massachusetts General Hospital"]