[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558498":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":20,"enrollmentInfo":40,"targetDuration":20,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":54,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":20},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pemigatinib combined with immune checkpoint inhibitor","EXPERIMENTAL","Pemigatinib 13.5mg，two weeks on and one week off, and with immune checkpoint inhibitor selected by investigator.",[13],"Drug: Pemigatinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pemigatinib","Pemigatinib and immune checkpoint inhibitors",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"TAO QIN, MD","CONTACT","020-34071337","qint6@mail.sysu.edu.cn",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","qintao","associate chief physician","100558498","phase-2-pemigatinib-and-immune-checkpoint-inhibitor-treated-fgfr123-alteration-advanced-solid-tumor-100558498",false,"NCT06551896","Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1\u002F2\u002F3 Alteration Advanced Solid Tumor","Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1\u002F2\u002F3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically or cytologically confirmed unresectable advanced solid tumors with failure or intolerance to standard treatments;\n* At least one measurable lesion per RECIST v1.1 criteria;\n* Gene testing confirms FGFR1\u002F2\u002F3 variants, including but not limited to mutations, fusions\u002Frearrangements in solid tumors;\n* Patients have not previously used specific small molecule multi-target inhibitors of the FGFR pathway, as assessed by investigators, and have been treated with immune checkpoint inhibitors;\n* ECOG performance status of 0-1;\n* Expected survival time \\> 3 months;\n* Laboratory criteria:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL in the past 14 days without granulocyte colony-stimulating factor;\n  2. Platelets ≥ 100 x 10⁹\u002FL without transfusion in the past 14 days;\n  3. Hemoglobin \\> 9 g\u002FdL in the last 14 days without transfusion or erythropoietin;\n  4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or total bilirubin \\> ULN but direct bilirubin ≤ ULN;\n  5. AST, ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastasis);\n  6. Serum creatinine ≤ 1.5 x ULN and creatinine clearance (Cockcroft-Gault) ≥ 50 ml\u002Fmin;\n  7. Good coagulation function, defined as INR or PT ≤ 1.5 x ULN. If on anticoagulant therapy, PT should be within the therapeutic range of anticoagulants;\n* Female subjects of reproductive age must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1, Day 1). If the urine test is inconclusive, a blood test is required. Non-reproductive females are defined as post-menopausal for at least one year or surgically sterile;\n* Subjects with reproductive potential must use contraception with an annual failure rate of less than 1% during treatment and for 120 days after the last study drug dose (or 180 days after the last chemotherapy dose).\n\nExclusion Criteria:\n\n* Diagnosis of other malignancies within 3 years before the first dose, except for certain treated skin carcinomas and in-situ carcinomas;\n* Previous treatment with selective FGFR inhibitors;\n* Receipt of other investigational drugs within 21 days or antitumor drugs within 14 days before the first dose;\n* Unresolved toxicity from prior treatments unless ≤ Grade 1 or related to alopecia or fatigue;\n* Known symptomatic CNS metastasis or carcinomatous meningitis. Stable patients post-treatment with no evidence of progression may be eligible if steroid-free for at least 14 days;\n* History of allogeneic organ or hematopoietic stem cell transplantation;\n* Abnormal laboratory parameters:\n\n  1. Serum phosphate \\> 1.5 x ULN;\n  2. Elevated serum calcium or albumin-adjusted calcium outside the reference range;\n* Known HIV infection or positive HIV test;\n* Active or poorly controlled serious infection;\n* Need for drainage treatment for pleural effusion, ascites, or pericardial effusion;\n* Active hepatitis B or C infection with high viral load, or positive HBsAg or anti-HCV antibodies. Patients on antiviral therapy must meet lower thresholds;\n* Significant uncontrolled heart disease, including recent MI, severe heart failure, or uncontrolled arrhythmias;\n* Clinically significant ECG changes or history of significant cardiac issues; Screening QTcF interval \\> 480 ms, or JTc interval if applicable, must be ≤ 340 ms;\n* Uncontrolled hypertension despite treatment;\n* Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or higher cirrhosis;\n* Major surgery within 4 weeks before the first dose or planned major surgery during the study;\n* Unresolved complications from prior surgery;\n* Pregnant or breastfeeding women, or those planning to become pregnant during the study period and for safety follow-up;\n* Radiotherapy within 4 weeks before the first dose, except for non-CNS palliative radiotherapy with a 2-week washout period;\n* History of systemic electrolyte imbalance or ectopic soft tissue calcification;\n* Clinically significant corneal or retinal disease;\n* Use of potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before the first dose;","ALL","18 Years",{"count":41,"type":42},30,"ESTIMATED","INTERVENTIONAL",[45],"PHASE2","This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1\u002F2\u002F3 variant advanced solid tumors.",[48,49,50,51,52,53],"Urothelial Carcinoma","Breast Neoplasms","Lung Cancer","Gastric Cancer","Soft Tissue Sarcoma","Other Carcinoma",[17,55,56],"FGFR1\u002F2\u002F3 alteration","Solid tumor","NOT_YET_RECRUITING","2024-08-11",{"date":60,"type":61},"2024-08-13","ACTUAL",{"date":63,"type":42},"2024-08-15",{"date":65,"type":42},"2026-12-31",{"name":5,"class":6}]