[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-biliary-tract-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-biliary-tract-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,62],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100601227","phase-1-emavusertib-ca-4948-in-combination-with-cisplatin-gemcitabine-and-durvalumab-in-patients-with-untreated-advanced-or-metastatic-biliary-tract-cancer-100601227",false,"NCT07107750","Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer","Phase I Trial of Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n* Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. Patients whose tumor have mixed histology but predominantly (\\>50%) adenocarcinoma are allowed.\n* Measurable defined by RECIST v1.1.\n* No prior systemic treatment for advanced unresectable or metastatic BTC with the following exceptions:\n\n  * Neoadjuvant or adjuvant systemic therapy completed \\> 6 months from planned C1D1.\n  * Up to two prior cycles of gemcitabine\u002Fcisplatin\u002Fanti-PD1 with no evidence of disease progression is allowed\n* At least 18 years of age.\n* ECOG performance status 0, 1, or 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN\n  * Creatinine clearance ≥ 35 mL\u002Fmin by Cockcroft-Gault\n  * INR ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤1.5 x IULN\n* Creatinine phosphokinase (CPK) elevation at screening \\\u003C Grade 2 (CPK \\\u003C 2.5 x IULN).\n* Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start.\n* The effects of emavusertib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 90 days after completion of the study.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment. Use of medical marijuana is permitted.\n* A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of BTC in the opinion of the investigator\n* History of allogeneic organ or stem cell transplant.\n* Currently receiving any other investigational therapeutic agents. Investigational tracers related to imaging studies are allowed with a 7 day-washout.\n* Clinically active CNS metastasis; treated and asymptomatic metastasis allowed at the discretion of the sponsor\u002Finvestigator or site PI. Radiotherapy to the brain must be completed \\> 10 days prior to planned C1D1.\n* Chemoradiation with curative intent within 6 months prior to C1D1 of study therapy.\n* Palliative radiation therapy within 10 days prior to C1D1 of study therapy.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to emavusertib, gemcitabine, cisplatin, durvalumab, or other agents used in the study.\n* Concomitant use of drugs with a known risk of causing prolonged QTc (with exception of Zofran if needed for supportive care) and\u002For Torsades de Pointes or a history of risk factors for Torsades de Pointes.\n* Presence of interstitial lung disease or pneumonitis ≥ G2 at time of screening.\n* Administration of a live attenuated vaccine within 30 days prior to C1D1\n* QTc (Fridericia) \\>470ms on screening EKG.\n* Gastrointestinal condition which could impair absorption of emavusertib or inability to ingest emavusertib in the opinion of the investigator.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia in the opinion of the investigator.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of C1D1.\n* Patients with known HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines and in line with contraindicated concomitant medications is recommended.\n* Participants with active, known, or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussion with the sponsor-investigator or site PI.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study treatment except for adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (\\\u003C 5 days) up to 7 days prior to initiating study treatment is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.\n* History of grade 3 or greater rhabdomyolysis that did not completely resolve.\n* Patients are unwilling to adhere to the lifestyle guidance","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor microenvironment (TME) to render chemo- and immunotherapies effective in GI malignancy. Therefore, this trial is designed to evaluate the combination of emavusertib (CA-4948) and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer (BTC).",[26,27],"Metastatic Biliary Tract Cancer","Metastatic Biliary Tract Carcinoma","RECRUITING","2026-03-30",{"date":31,"type":32},"2026-04-03","ACTUAL",{"date":34,"type":32},"2026-03-27",{"date":36,"type":20},"2032-05-31",{"name":38,"class":39},"Washington University School of Medicine","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100558230","phase-1-ctx-009-with-gemcitabine-cisplatin-and-durvalumab-as-first-line-therapy-in-patients-with-unresectable-or-metastatic-biliary-tract-cancers-100558230","NCT06548412","CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers","Inclusion Criteria:\n\n1. Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CTX-009 in combination with durvalumab, gemcitabine, and cisplatin in patients \\\u003C18 years of age, children are excluded from this study.\n2. Ability to understand and the willingness to sign a written informed consent document.\n3. Histologically or cytologically confirmed (outside pathology reports will be accepted) unresectable advanced, metastatic, or recurrent BTC at the time of enrollment that has not been previously treated in the metastatic setting.\n4. Patients must have measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n5. ECOG performance status ≤2\n6. Patients must have adequate organ and marrow function within 14 days of treatment as described below (patients must be free of G-CSF treatment within 14 days prior to the lab test)\n\n   * absolute neutrophil count ≥1,000\u002FmcL\n   * platelets ≥100,000\u002FmcL\n   * Hemoglobin ≥ 9 g\u002FdL.\n   * WBC ≥ 3,000\u002Fmm3\n   * total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)\n   * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN (≤5×ULN w\u002F hepatic metastasis)\n   * Calculated creatinine clearance ≥ 60mL\u002Fmin (determined as per Cockcroft-Gault)\n   * Urine protein ≤ 1+ by dipstick\n   * Serum amylase and lipase level ≤ 1.5 X ULN\n   * Serum albumin ≥ 3.0 g\u002FdL\n7. No evidence of ongoing active infection.\n\n   * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n   * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients with asymptomatic and controlled brain cancer are eligible for inclusion if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n9. The effects of CTX-009 on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of CTX-009 administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n   * Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CTX-009 administration.\n\nExclusion Criteria:\n\n1. Previous treatment of the current malignancy. Patients who received prior perioperative treatment (adjuvant and neoadjuvant) are eligible.\n2. History of active interstitial lung disease.\n3. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on baseline imaging\n4. Major surgical intervention within 28 days of Day 1 (Biliary stent placement, biliary stent exchange, and Endoscopic retrograde cholangiopancreatography (ERCPs) are not considered major surgical interventions)\n5. Patients with percutaneous transhepatic biliary drains (PTBD)\n6. Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving). Unless symptomatic, imaging of the head is not required for screening.\n7. Has an active infection requiring systemic therapy, with the exception of HBV and HCV\n8. Known positive serology for HIV (Human immunodeficiency virus)\n9. A history of the following hemorrhage-related or gastroenterological disease:\n\n   * Active hemorrhage, hemorrhagic diathesis, coagulopathy, or tumor in great arteries\n   * History of clinically significant gastroenterological disease, such as peptic ulcer, GI bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms, and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease (IBD)\n10. Active, uncontrolled autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with vitiligo, psoriasis, primary sclerosing cholangitis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n11. Active, uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)\n12. Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) within 2 weeks prior to screening, or is expected to need those drugs during the clinical study.\n13. A history of the following cardiovascular diseases in past 5 years:\n\n    * Congestive heart failure (CHF) that corresponds to Class II or a higher class (or less than 50% of left ventricular ejection fraction (LVEF)) under New York Heart Association (NYHA) classification.\n    * Uncontrolled hypertension (SBP\u002FDBP \\>140\u002F90 mmHg) (e.g., patient with SBP\u002FDBP \\>140\u002F90 mmHg despite the best care including optimizing the anti-hypertensive medication regimen)\n    * History of hypertensive crisis or pre-existing hypertensive encephalopathy\n    * Pulmonary hypertension\n    * Myocardial infarction\n    * Uncontrolled arrythmia\n    * Unstable angina\n14. Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product.\n15. History of hypersensitivity reactions to any components of the investigational product or other drugs of the same class (humanized\u002Fhuman monoclonal antibody drugs)\n16. Patients who are receiving any other investigational agents.\n17. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab. Note: While enrolled, patients should not receive any live vaccines while receiving durvalumab and up to 30 days after last dose of durvalumab.\n18. Patients who experience any grade 3-4 gastrointestinal (GI) bleeding within 3 months preceding Day 1\n19. Diagnosis of hepatic encephalopathy\n20. History of malignant bowel obstruction\n21. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n22. Pregnant women are excluded from this study because CTX-009 is a recombinant bispecific antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CTX-009, breastfeeding should be discontinued if the mother is treated with CTX-009. These potential risks may also apply to other agents used.",{"count":48,"type":20},50,[23,50],"PHASE2","To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.",[26],"2026-01-15",{"date":55,"type":32},"2026-01-20",{"date":57,"type":32},"2025-01-22",{"date":59,"type":20},"2029-05-01",{"name":61,"class":39},"M.D. Anderson Cancer Center",{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100579013","phase-4-inetetamab-plus-chemotherapy--pd-1pd-l1-in-her2-advanced-biliary-cancer-100579013","NCT06818773","Inetetamab Plus Chemotherapy ± PD-1\u002FPD-L1 in HER2+ Advanced Biliary Cancer","Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1\u002FPD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Males or females aged ≥18 years;\n* Histologically confirmed HER2-positive metastatic biliary tract cancer;\n* ECOG performance status of 0 to 1;\n* No prior treatment with anti-HER2 therapies;\n* Patients have not received any systemic anticancer treatment in the recurrent\u002Fmetastatic setting;\n* Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and\u002For radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;\n* Presence of at least one measurable lesion;\n* Adequate function of major organs as defined by the following criteria;\n* Estimated survival of ≥3 months;\n* Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to any component of the study drugs;\n* Previous treatment with anti-HER2 therapies;\n* Prior use of immunotherapy;\n* Use of immunosuppressive agents within 14 days before the first dose, except:\n\nIntranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg\u002Fday prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)\n\n* Known active central nervous system metastases or carcinomatous meningitis;\n* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;\n* Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;\n* Severe cardiac disease;\n* Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;\n* Neuropathy ≥ Grade I per NCI criteria;\n* Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;\n* History of immunodeficiency;\n* Participation in another drug trial within 4 weeks before screening;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;\n* Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.",{"count":70,"type":20},35,[72],"PHASE4","To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.",[26,75],"HER2 Positive","NOT_YET_RECRUITING","2025-02-07",{"date":79,"type":32},"2025-02-10",{"date":81,"type":20},"2025-02",{"date":83,"type":20},"2027-12-31",{"name":85,"class":39},"Eastern Hepatobiliary Surgery Hospital"]