[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-cancers":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100653976","phase-2-phase-2-study-of-daraxonrasib-in-recurrent-kras-mutant-biliary-tract-cancer-100653976",false,"NCT07793253","Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer","A Multi-Institutional Phase 2 Evaluation of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer","Inclusion Criteria:\n\n* Unresectable locally advanced or metastatic histologically or cytologically confirmed biliary tract cancer\n* Must have documented disease progression or intolerance of one prior systemic chemotherapy regimen (with or without immunotherapy) for unresectable and\u002For advanced stage disease.\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n* Have measurable disease based on RECIST 1.1.\n* Documented KRAS mutation\n* Adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* Willingness to provide serial tissue and blood samples for mandatory translational research.\n* Evidence of post-menopausal status or a negative pregnancy test in women of childbearing potential (WOCBP).\n* All participants must agree to use acceptable form of birth control while on study.\n* Ability to take oral medications and willingness to keep daily adherence record in a medication diary.\n* Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* Any systemic anti-cancer therapy for advanced BTC within 3 weeks of enrollment or 5 half-lives of the drug, whichever is shorter.\n* Prior treatment with any KRAS, RTK, or MEK inhibitor or other RAS-pathway targeting signal transduction inhibitor agents\n* Major surgery, extended field radiotherapy, or local regional therapy within 4 weeks from first dose of study drug, limited field radiotherapy within 2 weeks of first dose, or failure to recover from side effects of these prior therapies\n* Known additional malignancy that is progressing and requires active treatment.\n* Receiving concomitant medications that interfere with Daraxonrasib.\n* Significant cardiovascular disease.\n* Significant cardiac conduction abnormalities.\n* Impaired gastrointestinal function.\n* Active autoimmune disease\n* Clinically active ascites.\n* Active uncontrolled infection requiring systemic therapy within 72 hours prior to C1D1.\n* Known history of human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C.\n* Known history of central nervous system (CNS) metastases and\u002For history of uncontrolled seizures.\n* Any uncontrolled acute or chronic medical illness.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Pregnant or breastfeeding\n* Patient is unwilling or unable to follow the study schedule for any reason.\n* Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the anti-tumor efficacy of daraxonrasib monotherapy in patients with unresectable or advanced\u002Fmetastatic, KRAS-mutant BTC who have progressed on or are intolerant of 1st line systemic therapy.",[26,27,28,29,30,31],"Biliary Tract Cancers","Intrahepatic Cholangiocarcinoma (Icc)","Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma","Ampulla of Vater Carcinoma","Ampullary Carcinoma",[33,34,35,36,37,38,39,40],"Daraxonrasib (RMC-6236)","KRAS (Kirsten rat sarcoma virus) mutations","Immunotherapy","Biliary Tract Cancer","Liver Cancer","Carcinoma","Metastatic Cancer","Gastrointestinal Cancer","NOT_YET_RECRUITING","2026-08-25",{"date":44,"type":45},"2026-08-28","ACTUAL",{"date":47,"type":20},"2026-11",{"date":49,"type":20},"2030-11",{"name":51,"class":52},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100522581","phase-1-study-to-assess-adverse-events-and-change-in-disease-activity-in-adult-participants-with-select-advanced-solid-tumor-indications-receiving-intravenous-iv-abbv-400-100522581","NCT06084481","Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400","A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications","Inclusion Criteria:\n\n* Laboratory values meeting the criteria laid out in the protocol.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+\u002FHER2-breast cancer (HR+\u002FHER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)\u002Fprimary peritoneal\u002Ffallopian tube cancer (by World Health Organization \\[WHO\\] criteria). Participant meets the criteria for disease activity laid out in the protocol.\n\nExclusion Criteria:\n\n* Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period.\n* Unresolved clinically significant AEs \\> Grade 1 from prior anticancer therapy.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol.\n* History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.\n* Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required.\n* History of other active malignancy, with the exception of those laid out in the protocol.\n* Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.",{"count":62,"type":20},325,[64],"PHASE1","Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.\n\nABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \\[HR+\\]\u002FHER2-breast cancer \\[BC\\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)\u002Fprimary peritoneal\u002Ffallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide.\n\nIn cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+\u002FHER2-BC, HNSCC, and PROC\u002Fprimary peritoneal\u002Ffallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[67,68,26,69,70,71,72,73],"Hepatocellular Carcinoma","Pancreatic Ductal Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Triple Negative Breast Cancer","Hormone Receptor+\u002FHuman Epidermal Growth Factor Receptor 2 Negative Breast Cancer","Head and Neck Squamous-Cell Carcinoma","Platinum Resistant High Grade Epithelial Ovarian Cancer",[67,68,26,69,70,71,72,73,75,76,77,78],"Solid Tumors","Advanced Solid Tumors","ABBV-400","bevacizumab","RECRUITING","2026-08-21",{"date":82,"type":45},"2026-08-24",{"date":84,"type":45},"2023-11-09",{"date":86,"type":20},"2027-09",{"name":88,"class":89},"AbbVie","INDUSTRY",54,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":53},"100559476","phase-1-targeting-driver-oncogenes-with-a-peptide-vaccine-plus-durvalumab-and-tremelimumab-for-patients-with-biliary-tract-cancers-btc-100559476","NCT06564623","Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)","A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers","Inclusion Criteria:\n\n* Age ≥18 years\n* Must have a histologically- or cytologically, proven biliary tract cancer (BTC) previously treated with gemcitabine\u002Fcisplatin\u002Fanti-PD(L)1 therapy.\n* Must have evidence of radiological disease, must accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.\n* Must have sufficient archival tumor tissue for next-generation sequencing (NGS) and immune-phenotyping.\n* Have a BTC containing at least one of the oncogenic mutation\u002Falterations targeted by the vaccine.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Must have body weight of \\>30 kg.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have disease controlled prior to enrollment.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Must have a life expectancy of at least 12 weeks.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational product during the last 2 weeks.\n* Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Any of the following procedures or medications within 2 weeks prior to initiation of study treatment:\n\n  * Systemic or topical steroids at immunosuppressive doses (\\> 10 mg\u002Fday of prednisone or equivalent). The following are exceptions to this criterion:\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n  * Palliative or adjuvant radiation or gamma knife radiosurgery.\n  * Chemotherapy or checkpoint inhibitor targeting anti-Pd1\u002FPD-L1.\n* Within 4 weeks prior to initiation of study treatment:\n\n  * Any investigational cytotoxic drug.\n  * Any investigational device.\n  * Non-oncology vaccines containing live virus.\n  * Allergen hyposensitization therapy.\n  * Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin.\n  * Major surgery.\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n* All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n* Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.\n* Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.\n* History of severe hypersensitivity reaction to any monoclonal antibodies or related compounds or to any of its components.\n* History of leptomeningeal carcinomatosis.\n* Patient has a known history or evidence of brain metastases.\n* Has an active known or suspected autoimmune disease or which has required systemic therapy in the last 5 years.\n* Known history of interstitial lung disease or of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Has a pulse oximetry \\\u003C 92% on room air.\n* Requires the use of home oxygen.\n* Has a known history of Human Immunodeficiency Virus (HIV)\u002FAIDS\n* Has active co-infection with HBV (hepatitis B virus) and HCV (hepatitis C virus) or coinfected with HBV and hepatitis delta virus (HDV)\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years requiring systemic therapy or expected to require active therapy within the clinical study period.\n* Has a diagnosis of immunodeficiency.\n* Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoietic stem cell transplant will be excluded.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Patient is at the time of signing informed consent a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n* Patient is unwilling or unable to follow the study schedule for any reason.\n* Pregnant or breastfeeding.\n* WOCBP and men with female partners (WOCBP) who are not willing to use contraception.\n* Evidence of clinical ascites requiring paracentesis in the last 4 weeks.\n* History of malignant bowel obstruction.",{"count":99,"type":20},25,[64],"The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.",[26],[36,104,105,35,106,107,108,109,38],"Duvalumab","Tremelimumab","mBTCvax (peptide vaccine + Poly-ICLC (Hiltonol))","Anti PD-L1","Anti-Cytotoxic T-lymphocyte antigen 4 (CTLA-4)","Hiltonol","2026-05-05",{"date":112,"type":45},"2026-05-08",{"date":114,"type":45},"2025-05-27",{"date":116,"type":20},"2029-03",{"name":51,"class":52}]