[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"other-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:other-solid-tumor":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100433552","phase-1-brigatinib-in-pediatric-and-young-adult-patients-with-alk-alcl-imt-or-other-solid-tumors-100433552",false,"NCT04925609","Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors","A Phase I\u002FII Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors","Briga-PED","Inclusion Criteria:\n\n1. Patients must be 1 and \\\u003C 26 years of age at the time of enrollment, and able to swallow brigatinib tablets at the time of enrollment, with a minimum weight of 10 kg. Note: for phase 1 only patients ≤18 years old will be eligible, A liquid formulation for children with a weight lower than 10 kg or for those that cannot swallow tablets is in development.\n2. Patients must have a confirmed diagnosis of cancer histologically at baseline. In patients where a repeat biopsy at relapse (or moment of refractory disease) is considered not feasible by the treating physician, archived material from diagnosis needs to be available for central review.\n3. Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to be available for central laboratory confirmation of ALK status. For ALK+ ALCL, detection of ALK with immunohistochemistry (IHC) is sufficient for inclusion, all others require molecular evidence of a ALK fusion gene or mutation by FISH, PCR or NGS. ALK detection will be confirmed centrally with FISH.\n4. For Phase 1:\n\n   * Patients with ALCL must be relapsed\u002Frefractory or intolerant to standard therapies. Refractory disease for ALCL is defined as:\n\n     o no response to ALCL99\u002Fother standard of care chemotherapy (SD or PD of measurable lesions), and\u002For\n\n     o MRD-positivity by qualitative PCR for NPM-ALK prophase after one block ALCL99\u002Fother standard of care chemotherapy (before the second course of chemotherapy).\n   * Patients with relapsed\u002Frefractory (R\u002FR) IMT must not be suitable for curative surgical resection without causing mutilation. Newly diagnosed patients with unresectable ALK+ IMT, or when surgery would imply severe mutilation may also be included, as well as metastatic disease.\n   * Patients with other solid tumors (excluding IMT) must have relapsed or refractory disease.\n5. For Phase 2, patients must have measurable and\u002For evaluable disease:\n\n   * Patients with ALCL must be relapsed\u002Frefractory. Refractory disease for ALCL is defined as:\n\n     * no response to ALCL99\u002Fother standard of care chemotherapy (SD or PD of measurable lesions), and\u002For\n     * MRD-positivity by qualitative PCR for NPM-ALK prophase after one block ALCL99\u002Fother standard of care chemotherapy (before the second course of chemotherapy).\n   * Patients with R\u002FR IMT Relapsed\u002Frefractory ALK+ IMT, or newly diagnosed, including advanced and metastatic, ALK+ IMT which cannot be surgically resected without causing mutilation\n6. Performance Status: Karnofsky performance status ≥40% for patients \\>16 years of age or Lansky Play Scale ≥40% for patients ≤16 years of age.\n7. Patients must not be receiving other investigational medications (defined as medicinal products not yet approved for any indications, including alternative\u002Fherbal therapies) within 30 days of first dose of study drug or while on study.\n8. For patients receiving prior therapy:\n\n   * Patients who already received previous treatment with ALK inhibitors except for brigatinib can be included in this study.\n   * Patients must have recovered to Grade \\\u003C2 NCI CTCAE v5.0 or to baseline, from any nonhematologic toxicities (except alopecia and peripheral neuropathy) due to previous therapy.\n   * Patients who relapsed while receiving cytotoxic therapy: at least 14 days must have passed since the completion of the last dose of chemotherapy before the first dose of brigatinib can be given.\n   * Patients who have experienced relapse after a prior HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 45 days posttransplant at the time of enrollment.\n   * Hematopoietic growth factors: before the first dose of brigatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days must have passed since completion of therapy with pegfilgrastim.\n   * Biologics and Targeted Therapies:\n\n     o Immunotherapy: Before the first dose of brigatinib, at least 30 days must have passed after the completion of any type of immunotherapy, (i.e. monoclonal antibodies \\[anti-PD1\u002FPDL1\\], tumor vaccines, chimeric antigen receptor \\[CAR\\] T cells, etc.).\n\n     o Other: before the first dose of brigatinib, at least 7 days must have passed since the last dose of a biologic agent. For agents that have known adverse events (AEs) occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor's medical monitor\u002Fdesignee.\n\n     o Immunosuppressive therapy: Before the first dose of brigatinib, at least 14 days must have passed after the completion of immunosuppressive therapy (including regimens following stem cell transplant).\n\n     o For symptomatic patients that urgently need relief (i.e. airway obstruction), therapeutic doses of corticosteroids may be administered for a short course (up to 5 days).\n\n     o Radiotherapy (XRT): No washout period is necessary for radiation given to any extramedullary site other than the CNS and lungs; ≥45 days must have passed if patient received prior total body irradiation or craniospinal or cranial XRT; ≥28 days must have passed if patient received radiotherapy to the lung. For patients receiving XRT to both lungs, or in case of stereotactic radiotherapy, the PIs should be consulted before inclusion.\n9. Patients must meet the organ function and system function requirements as stated below:\n\n   * Patients must have adequate renal and hepatic function as indicated by the following laboratory values:\n\n     o Patient's serum creatinine must be ≤ 1.5 x institutional upper limit of normal (ULN) according to age. If the serum creatinine is greater than 1.5 x institutional ULN, the patient must have a radioisotope GFR ≥ 70mL\u002Fmin\u002F1.73m2\n     * Adequate liver function defined as: direct bilirubin ≤1.5 times the upper limit of normal (ULN) for age AND AST and ALT must be ≤5 times the ULN for age (unless related to involvement of the liver or histiocytic\u002Fmacrophage inflammatory process).\n   * No clinical, radiological or laboratory evidence of pancreatitis, including o Serum lipase must be \\\u003C2 × the ULN, and\n\n     o Serum amylase must be \\\u003C2 × the ULN.\n   * Absolute neutrophil count: ≥0.75 × 10 9\u002FL, except in case of macrophage activation syndrome (MAS) or bone marrow involvement.\n   * Platelet count o In phase 1: Platelet count: ≥75 × 10\\^9\u002F L, except in case of MAS or bone marrow involvement o In phase 2: : Platelet count: ≥75 × 10\\^9\u002F L, except in case of MAS or bone marrow involvement. For patients post SCT, platelet count ≥50 × 10\\^9\u002F L is accepted.Hemoglobin ≥8 g\u002FdL or 5.0 mmol\u002FL (red blood cell \\[RBC\\] transfusions to achieve this value are allowed with the condition that the patient has no signs of active bleeding or hemolysis).\n10. Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram OR left ventricular ejection fraction of ≥50% by multigated acquisition scan.\n11. Normal QT interval corrected per Fridericia method (QTcF) on screening electrocardiogram (ECG), defined as QTcF of ≤450 ms.\n12. Have a life expectancy of ≥3 months.\n13. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.\n14. Female patients with infants must agree not to breastfeed their infants while on this study.\n15. Contraception:\n\n    • Male and female patients of child-bearing potential must agree to use, an effective method for male and highly effective method for female, of contraception approved by the investigator during the study, following the CTFG recommendations, for at least 8 months for females and for at least 5 months for males after the last dose of brigatinib.\n\n    • Highly effective methods of contraception include (but not exclusively) the following contraceptive methods:\n\n    o combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation\n    * progestogen-only hormonal contraception associated with inhibition of ovulation\n    * intrauterine device (IUD), intrauterine hormone-releasing system (IUS), sexual abstinence.\n16. Voluntary written informed consent according to law and regulations\n\n    \\-\n\nExclusion Criteria:\n\nPatients meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Patients receiving systemic treatment with strong or moderate CYP3A inhibitors or inducers within 14 days or five half-life times whichever the less prior to the first dose of study drug (refer to Section 5.2 for a list of example medications).\n2. Diagnosis of another concurrent primary malignancy.\n3. Clinically significant cardiovascular disease, including any of the following:\n\n   * Myocardial infarction or unstable angina within 6 months of study entry.\n   * History of or presence of heart block, and\u002For clinically significant ventricular or atrial arrhythmias.\n   * Uncontrolled hypertension defined as persistent elevation of systolic and\u002For diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.\n4. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while patient is on study treatment.\n5. Any illness that affects gastrointestinal absorption.\n6. Ongoing or active systemic infection, active seropositive HIV, or known active hepatitis B or C infection.\n7. Any pre-existing condition or illness that, in the opinion of the investigator or sponsor, would compromise patient safety or interfere with the evaluation of the safety or efficacy of brigatinib.\n8. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible (patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved).\n9. Uncontrolled seizure disorder (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs are eligible).","ALL","1 Year","25 Years",{"count":21,"type":22},65,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.",[29,30,31],"Anaplastic Large Cell Lymphoma, ALK-Positive","Inflammatory Myofibroblastic Tumor","Other Solid Tumor","RECRUITING","2025-11-27",{"date":35,"type":36},"2025-12-05","ACTUAL",{"date":38,"type":36},"2022-08-18",{"date":40,"type":22},"2033-12",{"name":42,"class":43},"Princess Maxima Center for Pediatric Oncology","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100563724","early-phase-1-tp53-r248q-tcr-t-cell-therapy-for-advanced-solid-tumor-100563724","NCT06619886","TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor","Early Clinical Study to Evaluate the Safety and Efficacy of TP53 R248Q Mutation-specific TCR-T Cell Therapy for Advanced Solid Tumor","Inclusion Criteria:\n\n1. signed a written informed consent form (ICF), and can comply with protocol-specified visits and related procedures;\n2. aged ≥ 18 years, and ≤ 75 years, male or female;\n3. Subject must be pathologically confirmed with one of the histology below:\n\n   Lung carcinoma Colorectal adenocarcinoma Pancreatic adenocarcinoma Any other solid tumor (progression after receiving standard treatment);\n4. subjects with TP53R248Q mutation in genetic testing, as determined by DNA or RNA sequencing methods;\n5. if patients with brain metastases are asymptomatic and less than 3 brain lesions less than 3 cm in diameter, they may be eligible;\n6. ECOG score 0-1;\n7. Expected survival of no less than 12 weeks;\n8. According to RECISTv1.1 and mRECIST, subjects have at least 1 measurable lesion (lesions that have received local therapy such as radiotherapy and interventional therapy cannot be used as measurable lesions unless imaging evidence confirms that the lesion has clearly progressed), RECISTv1.1 is non-lymph node lesions with the longest diameter ≥ 10 mm on CT or MRI, and\u002For lymph node lesions with the short diameter ≥ 15 mm; mRECIST is non-lymph node measurable lesion criteria that meet RECISTv1.1 criteria, and showed intratumoral arterial enhancement in enhanced CT or MRI;\n9. subjects should provide fresh tumor tissue samples that meet the requirements or within 2 years before signing the ICF;\n10. Adequate organ and bone marrow function as defined by the following laboratory criteria: (1) bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelet (PLT) ≥ 75 × 109\u002FL (transfusion or hematopoietic stimulating factor not acceptable within 14 days prior to Screening); (2) hemoglobin ≥ 90 g\u002FL; (3) liver function: total bilirubin ≤ 2.5 × ULN; alanine aminotransferase ≤ 5 × ULN; aspartate aminotransferase ≤ 5 × ULN; (4) renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); (5) coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (INR between 2.0 and 3.0 is required for subjects receiving prophylactic anticoagulant therapy);\n11. Males of childbearing potential and females of childbearing potential must agree to use effective contraception from signing the ICF until one year after the last cell infusion and females of childbearing potential must have a negative blood pregnancy test at screening.\n\nExclusion Criteria:\n\n1. previous bone marrow or organ transplantation (including but not limited to liver transplantation) or waiting for transplantation;\n2. previous or concurrent history of other malignancies (cured and at least 2 years before screening without recurrence of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or radical treatment of local prostate cancer, radical resection of ductal carcinoma in situ can be enrolled in the study);\n3. hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and HBV DNA \\> 500 IU\u002FmL (lower limit of detection \\< HBV DNA ≤ 500 IU\u002FmL, clear lymphocyte conditioning medication before the need for at least 14 days of antiviral therapy and continuous antiviral therapy during the study can be enrolled); hepatitis C virus (HCV) antibody positive and HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive;\n4. HLA antibody positive subjects, including weak positive, positive and strong positive (those with different HLA typing sites from TP53R248QTCR-T cell injection can be enrolled in the study);\n5. previous treatment with other cell products or TP53 targeted drugs;\n6. treatment with any fluorouracil chemotherapeutic drugs or small molecule targeted drugs within 14 days or 5 half-lives (whichever is shorter) before screening, and any antineoplastic biological agents or non-fluorouracil chemotherapeutic agents; radical radiotherapy or extensive radiotherapy within 28 days before screening (except palliative radiotherapy for non-target lesions performed locally to relieve symptoms); traditional Chinese medicine\u002FChinese herbal medicine and local interventional therapy with antineoplastic indications within 14 days before screening;\n7. adverse events caused by previous antineoplastic therapy have not yet recovered to grade 1 or baseline levels, except for alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy;\n8. live attenuated vaccination within 28 days before screening, or live attenuated vaccination during the study;\n9. major surgical treatment (except liver mass biopsy) within 28 days before screening, or major surgical treatment during the study;\n10. Requirement for chronic systemic corticosteroids (at doses ≥ 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first study drug infusion or during the study, with the exception of inhaled or topical use;\n11. Subjects with fungal, bacterial, viral, tuberculosis or other infection requiring systemic anti-infective therapy within 14 days prior to screening;\n12. Patients with active or previous autoimmune diseases that may relapse, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.;\n13. Previous or current interstitial lung disease, dust disease, radiation pneumonitis, severely impaired pulmonary function and other conditions;\n14. Third space effusion that is not clinically well controlled before screening, such as pleural effusion and ascites that cannot be controlled by drainage or other methods;\n15. History of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    * severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, grade II-III atrioventricular block, etc.;\n    * prolonged QT interval corrected by Fridericia formula (QTcF), \\> 450 ms in men and \\> 470 ms in women;\n    * acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other ≥ Grade 3 cardiovascular and cerebrovascular events within 6 months before screening;\n    * presence of heart failure with New York Heart Association (NYHA) functional class ≥ II or left ventricular ejection fraction (LVEF) \\< 50%;\n    * clinically uncontrolled hypertension, systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg.\n16. Patients with a history of pulmonary embolism or severe lower extremity deep venous thrombosis, need to undergo inferior vena cava filter placement and other interventional therapy or need to use therapeutic doses of anticoagulants during screening;\n17. Subjects are participating in other interventional clinical studies;\n18. Pregnant or lactating women;\n19. Researchers believe that subjects have other conditions that may affect compliance or are not suitable for participating in this study.","18 Years","75 Years",{"count":54,"type":22},9,[56],"EARLY_PHASE1","To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A\\*11:01 allele.",[59,60,61,62,31],"Solid Tumor, Adult","Lung Adenocarcinoma","Pancreas Cancer","Colorectal Cancer",[64,65,66],"TP53-R248Q","TCR-T","advanced solid tumor","NOT_YET_RECRUITING","2024-09-28",{"date":70,"type":36},"2024-10-01",{"date":72,"type":22},"2024-09-24",{"date":74,"type":22},"2027-10-31",{"name":76,"class":43},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",1]