[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-solid-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,42,69,98,132,159,197,222,243,284,306,326],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100643340","phase-1-a-clinical-study-comparing-the-bioavailability-of-hrs-2189-tablets-100643340",false,"NCT07639905","A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets","A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects","Inclusion Criteria:\n\n1. Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.\n2. Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).\n3. Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg\u002Fm2 \\[BMI = weight (kg) \u002F height2 (m2)\\] (including both endpoints).\n4. Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.\n2. Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.\n3. Has a history of drug allergy, or is known to be allergic to the study drug\u002Frelated drugs or excipients.\n4. Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.\n5. Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.\n6. Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result.\n7. Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result.\n8. The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study.\n9. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.\n10. Pregnant and lactating women.\n11. Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.\n12. Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},28,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.",[28],"Malignant Solid Tumor","NOT_YET_RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-10","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2026-07",{"name":39,"class":40},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":21},"100373683","phase-1-study-of-ifinatamab-deruxtecan-ds-7300a-i-dxd-in-participants-with-advanced-solid-malignant-tumors-100373683","NCT04145622","Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors","Phase I\u002FII, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n* Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator\n* Has adequate cardiac, hematopoietic, renal and hepatic functions\n* Has an adequate treatment washout period prior to start of study treatment\n* Has a pathologically documented advanced\u002Funresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.\n\nFor Expansion Cohort 4 2L ESCC participants only:\n\n* Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.\n\nExclusion Criteria:\n\n* Has prior treatment with B7-H3 targeted agent, including I-DXd.\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.\n* Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.\n* Uncontrolled significant cardiovascular disease\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen\n* Has an uncontrolled infection requiring systemic therapy.\n* Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.",{"count":50,"type":22},250,[25,52],"PHASE2","This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.\n\nThe primary purpose of the parts are:\n\n* Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).\n* Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.\n\nThis study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.\n\nThe number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:\n\n* they withdraw\n* their disease gets worse\n* they experience unacceptable side effects.",[55,28],"Advanced Solid Tumor",[55,57,58],"Malignant Tumor","Ifinatamab deruxtecan (I-DXd)","RECRUITING","2026-05-27",{"date":62,"type":33},"2026-05-29",{"date":64,"type":33},"2019-11-03",{"date":66,"type":22},"2029-10-31",{"name":68,"class":40},"Daiichi Sankyo",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100475241","phase-1-safety-and-efficacy-of-cyclophosphamide-sorafenib-bevacizumab-and-atezolizumab-in-pediatric-solid-tumor-patients-100475241","NCT05468359","Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients","ANGIO-A: Safety and Tolerability of Oral Cyclophosphamide and Sorafenib With Intravenous Bevacizumab With the Addition of Atezolizumab in Pediatric Solid Tumor Patients","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C 30 years at the time of enrollment on study.\n* Willingness to enroll on the St. Jude Molecular Analysis of Solid Tumors (MAST) study.\n* Diagnosis\n* Part 1: Patients with refractory or recurrent (relapsed) solid tumors accessible by biopsy for which there is no standard therapy are eligible.\n* Part 2: Patients with one of the following diagnoses:\n* Biopsy accessible refractory or recurrent (relapsed) hepatocellular carcinoma\n* Biopsy accessible refractory or recurrent (relapsed)or FL-HCC, DSRCT or non-CNS MRT.\n* Performance level: Karnofsky \\> 50 for patients \\> 16 years of age and Lansky \\> 50 for patients \\\u003C 16 years of age (See Appendix III). Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Disease status: Patients must tumors that are unresectable and have either measurable or evaluable disease that is accessible by biopsy\n* Organ function: Must have adequate organ and bone marrow function as defined by the following parameters:\n* Patients with solid tumor not metastatic to bone marrow:\n\n  * Peripheral absolute neutrophil count (ANC) \\>1,000\u002Fmm3\n  * Platelet count \\> 75,000\u002Fmm3 (no transfusion within 7 days of enrollment)\n  * Hemoglobin \\> 8 g\u002FdL (with or without support)\n* Patients with solid tumor metastatic to bone marrow will be eligible for study but not evaluable for hematologic toxicity. These patients must not be known to be refractory to red cell or platelet transfusions. At least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity. If dose limiting hematologic toxicity is observed at any dose level, all subsequent patients enrolled must be evaluable for hematologic toxicity.\n* Adequate renal function defined as serum creatinine based on age as shown in Table 1, or creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age).\n* Adequate hepatic function defined as total bilirubin \\\u003C 5x upper limit of normal (ULN) and AST\u002FALT \\\u003C 3 x ULN for age.\n* Adequate cardiac function defined as shortening fraction \\> 28% OR ejection fraction of ≥ 47% by echocardiogram.\n* Adequate blood clotting defined as PT\u002FPTT \\\u003C 1.2 x ULN without factor replacement products for 7 days\n* Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy during the study and for at least 5 months after last dose of therapy.\n* Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, surgery, or radiotherapy prior to entering this study:\n* Myelosuppressive chemotherapy: Patient has not received myelosuppressive chemotherapy within 1 weeks of enrollment onto this study (within 2 weeks of estimated therapy start date) (4 weeks if prior nitrosourea).\n* Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim.\n* Biologic (anti-neoplastic agent): At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.\n* Monoclonal antibodies: At least 14 days (at least 21 days from therapy start date) must have elapsed since the completion of therapy with a monoclonal antibody.\n* Radiotherapy: At least 1 week (2 weeks from estimated therapy start date) must have elapsed since any irradiation; at least 5 weeks (at least 6 weeks from estimated therapy start date) must have elapsed since craniospinal RT or substantial bone marrow irradiation.\n* Chemoembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of chemoembolization\n* Radioembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of radioembolization\n* Cardiac disease or hypertension: Patients must not have a history of myocardial - infarction, severe or unstable angina, or severe peripheral vascular disease. Hypertension must be well controlled on stable doses of medication for at least two weeks.\n* Female participant who is post-monarchal must have a negative urine or serum pregnancy test.\n* Life expectancy of at least 8 weeks\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Currently receiving other investigational drugs.\n* Unwilling or unable to comply with the safety monitoring requirements of this protocol.\n* Tumor not safely accessible by biopsy\n* Inability or unwillingness of research participant or legal guardian \u002F representative to give written informed consent.\n* Surgical procedures and serious or non-healing wounds: patients with a documented, chronic non-healing wound, ulcer, or bone fracture or history of a major surgical procedure or significant traumatic injury within 28 days prior to beginning therapy are excluded due to preclinical evidence supporting the potential for delayed wound healing.\n* Minor surgical procedures for minimally invasive biopsies will be allowed. For minor surgeries, the wound must be healed, and 7 days elapsed since surgery. For procedures such as the placement of an indwelling IV catheter, it is recommended that bevacizumab be postponed for at least 24 hours after the procedure.\n* Thrombosis: Patients must not have a deep venous or arterial thrombosis (including pulmonary embolism) within the last three months prior to study entry and must not have a known thrombophilic condition (i.e., protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome).","30 Years",{"count":78,"type":22},64,[25,52],"This is a phase I\u002FII study to evaluate the safety of combining intravenous (IV) atezolizumab and bevacizumab every three weeks, with daily oral cyclophosphamide and pharmacokinetic (PK)-guided sorafenib in children and adolescent and young adults (AYA) with relapsed or refractory solid malignancies (Part 1), and then evaluate the response rate of this combination in children, AYA with relapsed or refractory fibrolamellar carcinoma (FLC) and other rare solid malignancies (Part 2).\n\nPrimary Objectives Part 1\n\n* To establish the safety associated with the administration of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory solid tumors\n* To determine if sorafenib systemic exposure can be successfully targeted to an AUC between 20 and 55 hr·µg\u002FmL by Day 21 of cycle 1 in 60% of evaluable patients, when given in combination with cyclophosphamide, bevacizumab, and atezolizumab in children and AYA with relapsed or refractory solid tumors\n\nPart 2\n\n* To evaluate the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory FLC following two cycles of therapy\n* To determine if the use of PK-guided sorafenib dosing to maintain a systemic exposure between 20 and 55 reduces the interpatient pharmacokinetic variability of sorafenib and the incidence of sorafenib- induced skin toxicities in children and AYA with relapsed or refractory FLC and other rare solid tumors\n\nParts 1 \\& 2\n\n* To determine if the combination of cyclophosphamide, PK-guided sorafenib and atezolizumab will result in increased intratumoral T-cell infiltration of CD8+C45RO+ cells between baseline and following two courses of therapy in pediatric children and AYA with relapsed or refractory solid tumors following two cycles of therapy\n* To characterize the pharmacokinetics of atezolizumab in combination with cyclophosphamide, PK-guided sorafenib and bevacizumab in children and AYA with relapsed or refractory solid tumors\n* To assess the feasibility of performing contrast enhanced ultrasound and explore the correlation between quantitative CEUS parameters and clinical response.\n\nSecondary Objectives\n\nPart 1\n\n• To describe the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory solid tumors following two cycles of therapy\n\nPart 2\n\n• To describe the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory FLC, HCC, desmoplastic small round cell tumor, malignant rhabdoid tumor, and other rare solid tumors following two cycles of therapy\n\nParts 1\\&2\n\n* To describe the number of children with liver tumors, initially judged unresectable at diagnosis, that can have their primary tumor resected after treatment with oral cyclophosphamide and sorafenib with intravenous bevacizumab and atezolizumab\n* To describe changes in immune cells in the peripheral blood at periodic times before and after treatment with this combination chemoimmunotherapy\n* To describe the PFS, EFS, and OS in patients treated with the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab, and atezolizumab in patients with relapsed or refractory FLC, DSRCT, MRT, HCC and other rare solid tumors",[82,83,28,84,85,86],"Refractory Solid Tumor","Hepatocellular Carcinoma","Pediatric Cancer","Pediatric Solid Tumor","Fibrolamellar Carcinoma","2026-05-18",{"date":89,"type":33},"2026-05-19",{"date":91,"type":33},"2022-11-07",{"date":93,"type":22},"2037-06",{"name":95,"class":96},"St. Jude Children's Research Hospital","OTHER",2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100371451","phase-2-a-study-evaluating-the-activity-of-anti-cancer-treatments-targeting-tumor-molecular-alterationscharacteristics-in-advanced--metastatic-tumors-100371451","NCT04116541","A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations\u002FCharacteristics in Advanced \u002F Metastatic Tumors.","MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations \u002FCharacteristics in Advanced \u002F Metastatic Tumors.","MegaMOST","Inclusion Criteria:\n\n* Male or female patients aged of at least 18 years on day of signing informed consent.\n* Patients with histologically confirmed diagnosis of metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapies or for which standard therapies does not exist or is\u002Fare not considered appropriate by the investigator.\n* A multidisciplinary molecular board must have recommended the specific MTT based on the following documented actionable alterations:\n\n  * Cohort HDM201-Ribociclib : amplification of CDK6 and\u002For CDK4, and\u002For CDKN2A homozygous deletion, and\u002For amplification of CCND1 and\u002For CCND3 with no deletion\u002Flosses more than single copy of RB1 by copy number and P53 wild-type.\n  * Cohort Cabozantinib : AXL, MET, VEGFR, VEGF, RET, ROS1, MER, TRKB, TIE-2 and\u002For Tyro3 activating mutations and\u002For amplification, and\u002For NTRK translocation and\u002For ROS1 translocation, and\u002For MET translocation.\n  * Cohort Alectinib : Activating ALK alterations: translocation, or selected mutations, or activating rearrangements following validation by central molecular tumor board of Centre Léon Bérard.\n  * Cohort Regoranib : Activating mutation and\u002For amplification and\u002For rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and\u002For CSFR1, and\u002For amplification of the ligands, and\u002For biallelic inactivation of SMAD4, following validation by central molecular tumor board of Centre Léon Bérard.\n  * Cohort Trametinib : Activating mutation and\u002For amplification of KRAS (except all KRAS G12 mutations), NRAS, HRAS and\u002For MAP2K; and\u002For biallelic inactivation of NF1; and\u002For activating mutation PTPN11; and\u002For amplification or translocation of BRAF, and\u002For translocation RAF1\n  * Cohort Trametinib + Dabrafenib : BRAF V600 mutation.\n  * Cohort Avapritinib : Activating mutations of KIT exon 17 or PDGFRA exon 18 associated or not to mutation on KIT exon 11 or PDGFRA exon 12\u002F14\n* Previously treated by at least one prior line of treatment in the advanced\u002Fmetastatic setting except for specific tumor type with no standard treatment approved and reimbursed in France following sponsor approval.\n* Documented radiological disease progression as per RECIST v1.1 and presence of at least one measurable lesion according to RECIST 1.1 criteria based on screening tumor assessment.\n* Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n* Adequate organ function\n* Adequate cardiovascular function\n* Specific toxicities related to any prior anti-cancer therapy must have resolved to grade ≤1 , except for alopecia (all grades), grade 2 neuropathy or anemia.\n* Unless infertility is proven, men must agree to use effective contraception\n* Women of child-bearing potential must have a negative serum pregnancy test within 7 days of first dose of study drug and agree to use effective contraception\n* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study procedures as per protocol.\n* Patient must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Patients amenable to therapy with curative intent.\n* Patients participating to another clinical trial with a medicinal product.\n* Patients previously treated with similar MTT meaning any agent targeting the same signaling pathways components.\n* Patients unable to swallow oral medication.\n* Patients with known hypersensitivity to excipients\n* Patients with symptomatic central nervous system (CNS) metastasis who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease.\n* Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include: basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of recurrence for ≥ 2 years.\n* Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of medications\n* Any clinically significant and\u002For uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results.\n* Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patients who are pregnant or breastfeeding women or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through after the last dose of trial treatment (depanding on cohort).",{"count":107,"type":22},455,[52],"This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment.\n\nPatients will be assigned to a treatment cohort based on molecular alterations\u002Fcharacteristics detected on tumor sample from primary tumor or metastatic lesion.\n\nIn this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced\u002Fmetastatic cancers.\n\nAll eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent.\n\nPatients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor:\n\n* Evidence of clinical benefit as assessed by the investigators,\n* Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease,\n* No decline in ECOG Performance Status (PS) that can be attributed to disease progression.",[28],[112,55,113,114,115,116,117,118,119,120,121],"Metastatic Solid Neoplasm","Genomic alteration","Targeted therapy","Cabozantinib","Ribociclib","HDM201","Alectinib","Trametinib","Dabrafenib","Avapritinib","2026-04-21",{"date":124,"type":33},"2026-04-24",{"date":126,"type":33},"2020-01-28",{"date":128,"type":22},"2027-10",{"name":130,"class":96},"Centre Leon Berard",10,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100627503","phase-2-a-phase-ii-clinical-study-of-utidelone-and-bevacizumab-with-or-without-etoposide-in-patients-with-brain-metastases-from-malignant-solid-tumors-100627503","NCT07449481","A Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors","A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors","Inclusion Criteria:\n\n* Subjects must provide informed consent for the trial and voluntarily sign the written informed consent form (ICF) prior to the study.\n* Aged 18-75 years, male or female.\n* Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC):The pathological type of NSCLC must be adenocarcinoma.For advanced NSCLC patients with positive EGFR sensitive mutations, ALK fusion, ROS1 fusion, RET fusion, BRAF V600E, or NTRK fusion mutations, they must have experienced disease progression after adequate targeted therapy for the corresponding mutation AND after at least one platinum-based chemotherapy regimen, or be intolerant to platinum-based therapy.Patients with NSCLC without driver gene mutations and patients with SCLC must have experienced disease progression after platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors, or be intolerant to the aforementioned therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-2.\n* At least one measurable lesion in the central nervous system (CNS).\n* Patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.\n* All toxicities related to prior anti-tumor treatment must have recovered to ≤ Grade 1 (CTCAE v5.0), except for alopecia of any grade, which is permitted.\n* CNS patients, based on screening brain Magnetic Resonance Imaging (MRI), must meet one of the following conditions:Untreated brain metastases not requiring immediate local therapy；Previously treated brain metastases, assessed by the investigator as having progressed after prior local CNS therapy and without clinical manifestations requiring immediate local therapy.\n* Routine blood tests within 1 week prior to enrollment are essentially normal (based on the normal ranges of each research center's laboratory):\n\nWhite blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL；\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL；\n\nPlatelet count (PLT) ≥ 100 × 10\\^9\u002FL；\n\nHemoglobin ≥ 9.0 g\u002FdL (Patients may receive blood transfusion or erythropoietin treatment to meet this criterion.)；\n\n-Liver and kidney function tests within 1 week prior to enrollment are essentially normal (based on the normal ranges of each research center's laboratory):\n\nTotal bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)；\n\nAlanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)；\n\nAspartate aminotransferase (AST\u002FSGOT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)；\n\nCreatinine clearance (Ccr) ≥ 60 ml\u002Fmin；\n\n* Expected survival ≥ 12 weeks.\n* Men of reproductive potential and women of childbearing potential must agree to use reliable contraception from signing the ICF until 180 days after the last dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result within ≤7 days before the first dose of study drug.\n\nExclusion Criteria for Lung Cancer with Brain Metastases:\n\n* History of other malignancies (including primary brain or leptomeningeal tumors) within the past 5 years, except for cured basal cell skin carcinoma or cervical carcinoma in situ.\n* Prior use of Utidelone injection or Bevacizumab.\n* Imaging shows tumor invasion of major blood vessels, unclear demarcation from vessels, or judged by the investigator as having a high probability of fatal massive hemorrhage due to tumor invasion of important vessels during the study (major thoracic vessels include the thoracic aorta, left pulmonary artery, right pulmonary artery, 4 pulmonary veins, superior vena cava, inferior vena cava, and aorta).\n* Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or scheduled elective surgery during the trial period.\n* History of Grade 3 or higher severe neurological adverse reactions related to prior anti-microtubule drug use.\n* Any untreated brain lesion \\> 2.0 cm, unless discussed and approved for enrollment by the investigator.\n* Ongoing use of systemic corticosteroids to control brain metastasis symptoms, with a total daily dose \\> 2 mg dexamethasone (or equivalent). However, a chronic stable dose ≤ 2 mg dexamethasone daily (or equivalent) may be permitted after discussion and approval by the investigator.\n* Any brain lesion deemed to require immediate local treatment, including (but not limited to) lesions where increased size in an anatomical location or possible treatment-related edema may pose a risk to the patient (e.g., brainstem lesions). Patients receiving local treatment remain eligible for the study based on criteria described in the CNS inclusion criteria, as determined by screening contrast brain MRI.\n* More than 2 episodes of seizures within 4 weeks prior to enrollment.\n* Poorly controlled hypertension, or history of hypertensive crisis or hypertensive encephalopathy.\n* History of hemoptysis within 6 months prior to enrollment, or evidence of bleeding tendency or significant coagulation dysfunction within the past month.\n* Current use of full-dose warfarin or equivalent agents, or use of aspirin (325 mg\u002Fday) within 10 days.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days, or anticipated need for such during the study.\n* Severe gastrointestinal toxicity prior to the first dose of study drug that has not recovered to below Grade 2; or confirmed presence of other clinically uncontrolled acute or chronic gastrointestinal diseases.\n* History or presence of interstitial lung disease, emphysema, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis, drug-induced interstitial lung disease, or radiation pneumonitis; or uncontrolled respiratory symptoms prior to the first dose of study drug.\n* Clinically significant cardiovascular disease, including but not limited to:\n\nHeart failure, myocardial ischemia or infarction, unstable angina, arrhythmia within the past 6 months or currently present, and New York Heart Association (NYHA) Class III-IV cardiac function.\n\nBaseline ECG showing prolonged QT\u002FQTc interval (QTcF: \\>450 ms for males, \\>470 ms for females).\n\nBaseline echocardiogram (ECHO) showing left ventricular ejection fraction (LVEF) ≤ 50%.\n\nPoorly controlled hypertension despite medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n\nHistory of cardiac surgery such as angioplasty, coronary artery bypass graft.\n\n* Peripheral neuropathy ≥ Grade 2, or skin abnormalities such as rash ≥ Grade 2 requiring treatment prior to the first dose of study drug, or any toxicity from prior anti-tumor treatment that has not recovered to ≤ Grade 1 per CTCAE v5.0 (except for Grade 2 alopecia).\n* History of drug abuse of psychotropic substances and inability to abstain, or patients with psychiatric disorders.\n* Pregnant or breastfeeding women.\n* Presence of any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that may interfere with treatment or follow-up.\n* Known or suspected allergy to any study drug or excipient.\n* Any reason that precludes the performance of brain magnetic resonance imaging with contrast.\n* Any other condition deemed by the investigator to make the patient unsuitable for participation in this trial.\n* Other conditions contraindicating the use of corticosteroids.","75 Years",{"count":141,"type":22},56,[52],"Brain metastasis represents one of the worst prognostic outcomes in advanced malignant tumors. Approximately 10% to 40% of patients with solid tumors develop brain metastases, a incidence rate significantly higher than that of primary malignant brain tumors. Over 80% of patients present with multiple brain metastases at diagnosis, often precluding surgical intervention.\n\nBrain metastases typically occur in the late stages of cancer. Patients have often received multiple prior therapies and developed resistance to first- and second-line drugs, leaving limited pharmacological options. The rapid growth of intracranial tumors poses an immediate threat to life. Consequently, radiotherapy and surgery currently form the cornerstone of clinical management for these patients. Thus, developing effective systemic therapies is an urgent and unmet medical need .\n\nUtidelone, a new-generation epothilone anticancer agent, has demonstrated good efficacy and safety. Previous studies indicate that utidelone achieves higher concentrations in most tissues, including the brain, compared to plasma, suggesting its ability to readily cross the blood-brain barrier . Furthermore, a Phase III clinical trial in metastatic breast cancer showed that utidelone in combination with capecitabine significantly improved the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to capecitabine alone in patients previously treated with anthracyclines and taxanes .\n\nA separate Phase II study demonstrated that bevacizumab combined with carboplatin achieved a central nervous system objective response rate (CNS ORR) of 63%, with a median PFS of 5.62 months and a median OS of 14.1 months in breast cancer patients with brain metastases . Regarding safety, utidelone has a relatively low incidence of adverse reactions aside from peripheral neurotoxicity .\n\nBased on this evidence, this proposed study aims to evaluate the efficacy and safety of utidelone and bevacizumab, combined with etoposide for breast cancer cohorts or without etoposide for lung cancer cohorts, in patients with malignant tumor brain metastases.",[28,145],"Brain Metastasis",[147,148,149],"NSCLC","SCLC","brain metastases","2026-03-26",{"date":152,"type":33},"2026-04-01",{"date":154,"type":22},"2026-05-01",{"date":156,"type":22},"2030-02-01",{"name":158,"class":96},"Tianjin Medical University Cancer Institute and Hospital",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":179,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100529282","phase-1-phase-i-study-of-tolododekin-alfa-ank-101-in-advanced-solid-tumors-100529282","NCT06171750","Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors","ANCHOR","Inclusion Criteria:\n\n* ≥ 18 years of age on day of signing informed consent\n* histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible\n* measurable disease per RECIST v1.1 - Note: Must have at least 1 tumor lesion with longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node lesions) that - For Part 1 only: can be easily palpated or detected by ultrasound to facilitate IT injection of ANK-101 (i.e., tumor in skin, muscle, subcutaneous tissue, or accessible lymph node) or; - For Part 2 only: can be accessed by interventional radiologic or endoscopic procedures for injection (e.g., ultrasound or computed tomography \\[CT\\] guided). - For Part 2 Dose Expansion Cohort only: Histologically confirmed Stage III or Stage IV NSCLC\n* Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced or metastatic CSCC not amenable to surgical management as determined by a multidisciplinary tumor board.\n* documented disease progression, be refractory to, or intolerant of existing SOC therapy(ies) known to provide clinical benefit (including surgical cure) or not be eligible for SOC therapy(ies)\n* ECOG performance status 0-1\n* life expectancy \\> 12 weeks\n* adequate bone marrow, hepatic and renal function\n* baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc interval \\> 460 msec\n* Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection\u002Fdisease\n* last dose of previous anticancer therapy (including investigational agents) ≥ 28 days, radiotherapy ≥ 14 days (targeted palliative radiotherapy is allowed for lesions not planned for injections), or surgical intervention ≥ 21 days prior to the start of treatment\n* resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1 (as per NCI CTCAE Version 5.0)\n* willing to provide pre- and post-treatment tumor biopsy samples if medically feasible\n* participant is capable of understanding and complying with protocol requirements\n\nExclusion Criteria:\n\n* injectable tumors impinging upon major airways or blood vessels\n* prior treatment with recombinant interleukin-12 (IL-12)\n* have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment\n* have received live vaccines within 28 days prior to the start of ANK-101 treatment\n* have primary or acquired immunodeficient states (e.g., leukemia, lymphoma)\n* a woman of childbearing potential (WOCBP) who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment or female participant who is breastfeeding\n* prior organ transplantation\n* known history of hepatitis B virus, known active hepatitis C virus, or a positive serological test at screening within 28 days prior to the start of treatment\n* HIV-infected participants with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease\n* active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 28 days prior to the start of treatment\n* known active central nervous system (CNS) metastases\n* congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias\n* uncontrolled bleeding disorders within 4 weeks prior to the start of treatment or known bleeding diathesis - Note: Part 2 only: Participants with active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* history of hypersensitivity to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20\n* other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and\u002For interpretation of the current study\n* any acute or chronic psychiatric problems or substance abuse disorder that, in the opinion of the Investigator, make the participant unsuitable for participation\n* Part 3 only: prior Grade 3 or greater immune-mediated adverse events (imAEs) following treatment with an agent that blocks the programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) pathway.\n* Part 3 only: hypersensitivity to cemiplimab or any of its excipients or contraindications to cemiplimab per approved local labeling",{"count":168,"type":22},97,[25],"This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.",[55,172,173,28,174,175,176,177,178],"Cutaneous Tumor","Subcutaneous Tumor","Solid Tumor","Metastatic Solid Tumor","Metastasis to Soft Tissue","Non Small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma",[180,181,182,183,184,185,186],"intratumoral","intratumoral injection","solid tumors","superficial tumors","nodal tumors","subcutaneous tumors","visceral tumors","2026-03-04",{"date":189,"type":33},"2026-03-06",{"date":191,"type":33},"2024-01-19",{"date":193,"type":22},"2027-06",{"name":195,"class":40},"Ankyra Therapeutics, Inc",5,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":41},"100579443","early-phase-1-proofprincip-intratu-tcells-singldoseimmuncheckpoininhib-gastro-esophage-adenocarcinoma-warid1a-mu-100579443","NCT06824363","ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w\u002FARID1a Mu","Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082","Inclusion Criteria:\n\n* Non metastatic GEC including locally advanced unresectable\n* Treatment naïve\n* Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS\u002FWES\n* MSI-Stable or pMMR\n* Age ≥ 18 years\n* Body weight \\> 66 pounds\n* ECOG ≤ 2\n* Repeat biopsy feasible\n* No clinically significant autoimmune disease\n\nExclusion Criteria:\n\n* Patients with known metastatic disease\n* Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma\n* Patients with uncontrolled autoimmune disease per investigator discretion\n* Inability or refusal to undergo biopsy procedures to obtain tissue samples",{"count":205,"type":22},34,[207],"EARLY_PHASE1","This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.",[210,28,211,212],"Solid Tumor, Adult","Stomach Adenocarcinoma","Esophageal Adenocarcinoma","2026-01-29",{"date":215,"type":33},"2026-01-30",{"date":217,"type":22},"2026-04",{"date":219,"type":22},"2028-07",{"name":221,"class":96},"University of California, Irvine",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":41},"100572582","phase-1-phase-iii-clinical-study-of-fh-006-for-injection-in-patients-with-malignant-solid-tumors-100572582","NCT06735144","Phase I\u002FII Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors","A Multicenter, Open Label Phase I\u002FII Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors","Inclusion Criteria:\n\n1. Women aged 18 to 75 (inclusive)\n2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.\n3. ECOG score is 0 or 1\n4. An expected survival of ≥3 months\n5. At least one target lesion according to RECIST v1.1 criteria\n6. Has a good level of organ function\n7. Patients voluntarily joined the study and signed informed consent\n\nExclusion Criteria:\n\n1. Have other malignancies within the past 5 years\n2. Active central nervous system metastasis without surgery or radiotherapy\n3. Presence with uncontrollable third space effusion\n4. Have undergone other anti-tumor treatment within 4 weeks before the first dose\n5. Has severe infection within 4 weeks before the first medication\n6. Any active autoimmune disease or a history of autoimmune disease\n7. A history of immune deficiency\n8. Has serious cardiovascular and cerebrovascular diseases\n9. Clinically significant history of lung disease\n10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I\n11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication\n12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug\n13. Presence of other serious physical or mental diseases or laboratory abnormalities",{"count":230,"type":22},200,[25,52],"Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.",[28],"2025-11-27",{"date":236,"type":33},"2025-12-05",{"date":238,"type":33},"2024-12-23",{"date":240,"type":22},"2027-12",{"name":242,"class":40},"Jiangsu HengRui Medicine Co., Ltd.",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":253,"conditions":254,"keywords":264,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100374121","canadian-cancers-with-rare-molecular-alterations-carma---basket-real-world-observational-study-bros-100374121","NCT04151342","CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)","CARMA-BROS","Inclusion Criteria:\n\n* Patients ≥ 18 years at cancer diagnosis\n* Diagnosed with malignant tumour(s) with molecular testing completed that identified rare molecular alterations\n* Accessible\u002Favailable molecular testing reports\u002Fdocumentation to confirm type(s) of molecular alteration(s) (resulting from the conduct of polymerase chain reaction \\[PCR\\] based next generation sequencing \\[NGS\\], immunohistochemistry \\[IHC\\], fluorescence in situ hybridization \\[FISH\\], liquid biopsy)\n* Canadian resident received follow-up for cancer care in Canada or is currently receiving\u002Fplanning follow-up for cancer care to occur in Canada at time of enrollment\n\nExclusion Criteria:\n\n* Previous refusal of the deceased patient, when living, to enroll in this study or patient approached for this study is unable to provide informed consent",{"count":251,"type":22},5500,"OBSERVATIONAL","This study will collect data on Canadian cancer patients that have uncommon\u002Frare changes in their tumours, such as alterations\u002Frearrangements in the genetic material inside cells - known as deoxyribonucleic acid, or DNA, which acts as a map and gives directions to the cells on how to make other substances the body needs - because some of these changes have been found to respond to different drugs that help to stop the cancer. These rare changes occur in genes such as but not limited to ALK, EGFR, ROS1, BRAF, and NTRK which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs), and KRAS G12C mutation, which now has a targeted inhibitor drug therapy for patients with non small cell lung cancer (NSCLC). The goals for the study are to compare the natural history of such cancers and the treatment outcomes, including toxicities and patient-reported outcomes, for the different therapies.",[255,256,28,257,258,259,260,261,262,263],"Cancer","Malignancies Multiple","Cancer, Therapy-Related","Molecular Sequence Variation","Genetic Alteration","Gene Fusion","Receptor Tyrosine Kinase Gene Mutation","RTK Family Gene Mutation","Ras (Kras or Nras) Gene Mutation",[265,266,267,268,269,270,271,272,273],"observational study","cancer","cancer therapies","molecular alterations","real-world evidence","real-world data","tyrosine kinase inhibitors","ambispective","ras GTPase inhibitors","2025-11-25",{"date":276,"type":33},"2025-12-03",{"date":278,"type":33},"2020-01-17",{"date":280,"type":22},"2029-12",{"name":282,"class":96},"University Health Network, Toronto",27,{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":97},"100487638","phase-1-a-study-to-evaluate-geh200520geh200521-18f-safety-and-tolerability-when-used-for-pet-scans-in-patients-with-solid-tumour-malignancies-100487638","NCT05629689","A Study to Evaluate GEH200520\u002FGEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies","A Phase 1a\u002F1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients With Solid Tumour Malignancies to Evaluate GEH200520 Injection \u002F GEH200521 (18F) Injection Safety and Tolerability, PET Imaging, Pharmacokinetics, and Changes in Imaging After Treatment","Inclusion Criteria:\n\n* The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed.\n* The subject is male or female, ≥18 years of age.\n* Subject has a life expectancy ≥12 weeks.\n* Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Subject has an unresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma, or an unresectable stage III-IV melanoma.\n* Subject is eligible for ICI treatment per Investigator judgement.\n* Subject has at least 1 measurable tumour lesion documented on CT\u002Fmagnetic resonance imaging (MRI) RECIST v1.1 during the last 12 months.\n* Subject has a tumour lesion(s) of which a biopsy can safely be obtained according to standard clinical care procedures.\n* Subject is male or female that agrees to adhere to the protocol contraception methods.\n\nExclusion Criteria:\n\n* Subject is unable to undergo all procedures in the study and\u002For is unable to remain still and tolerate the imaging procedure.\n* Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.\n* Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.\n* Subject has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has B or T cell lymphoma.\n* Subject has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has signs or symptoms of systemic infection within 2 weeks prior to imaging day.\n* Subject has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and\u002For the proposed ICI therapy.\n* Subject has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the subject at high risk from complications.\n* Subject has laboratory values out of range per protocol.\n* Subject has any safety laboratory test results (blood chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has had any major surgery within 4 weeks prior to enrollment.\n* Subject has been enrolled in another interventional clinical study within the 30 days before screening for this study, except for the study site IIS.\n* Subject is pregnant or planning to become pregnant or is breastfeeding.\n* Subject has a history of alcohol or drug abuse within the last year.\n* Subject has had treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to dosing with the IMP.\n* Subject has had treatment with systemic immunosuppressive medications within 2 weeks prior to dosing with the IMP.\n* Subject has received acute, low-dose, systemic immunosuppressant medications that, in the opinion of the Investigator, could compromise protocol objectives.\n* Subject has used systemic corticosteroids to treat inflammatory or autoimmune symptoms.",{"count":292,"type":22},50,[25],"Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days.\n\nPart B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment.\n\nSubjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit. Two late imaging transfer expected post follow up visit. The estimated duration for subject participation in Part B is approximately 64 days.",[28,296],"Oncology","2025-11-14",{"date":299,"type":33},"2025-11-17",{"date":301,"type":33},"2023-01-27",{"date":303,"type":22},"2029-03-10",{"name":305,"class":40},"GE Healthcare",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":97},"100603409","phase-1-a-phase-iii-clinical-study-of-fh-006-for-injection-in-patients-with-malignant-solid-tumors-100603409","NCT07136142","A Phase I\u002FII Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors","A Multicenter, Open Label Phase I\u002FII Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors","Inclusion Criteria:\n\n1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.\n2. Patients with unresectable recurrent or metastatic solid tumors.\n3. There is at least one lesion that could be measured.\n4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n5. Adequate organ functions as defined.\n6. Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) metastases.\n2. Subjects who had other malignancy in five years before the first dose.\n3. Patients with tumor-related pain that can not be controlled as determined.\n4. Patients with serious cardiovascular and cerebrovascular diseases.\n5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.\n6. Patients with severe infections.\n7. History of immunodeficiency.\n8. History of autoimmune diseases.\n9. Unresolved CTCAE Grade \\>1 toxicity attributed to any prior anti-tumor therapy.\n10. Active infection.\n11. Pregnant or nursing women.\n12. Known history of serious allergic reactions to the investigational product or its main ingredients.",{"count":314,"type":22},150,[25,52],"This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.",[28],"2025-08-21",{"date":320,"type":33},"2025-08-22",{"date":322,"type":22},"2025-08",{"date":324,"type":22},"2027-02",{"name":242,"class":40},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":41},"100450129","early-phase-1-assessment-of-the-safety-and-tolerability-of-ex-vivo-next-generation-neoantigen-selected-tumor-infiltrating-lymphocyte-til-therapy-in-advanced-epithelial-tumors-and-immune-checkpoint-blockade-icb-resistant-solid-tumors-100450129","NCT05141474","Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors","A Phase I Study to Assess the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors","NEXTGENTIL-ACT","Inclusion Criteria in the pretreatment phase:\n\n1. Patients must have histologically or cytologically proven metastatic or unresectable solid tumors. The disease must have progressed to at least one standard therapy (including at least one prior line with ICB for the group of patients with tumors where ICB is approved), or the patient is unable\u002Funwilling to receive standard therapy or no standard therapy exists for a particular disease.\n2. Patients must have at least one adequate lesion (primary tumor or metastasis) for resection or biopsy for TIL generation with minimal morbidity (preferentially using imaging-guided minimally invasive procedures).\n\n   Note: If this lesion was previously irradiated, the lesion must have demonstrated progression prior to resection\u002Fbiopsy.\n3. Patient must be at least 18 years old at the tissue procurement visit.\n4. Patient must understand and voluntarily sign an informed consent document before any study-related assessments\u002Fprocedures being conducted.\n5. Patient must be able and willing to comply to the study visit schedule and protocol requirements.\n6. Patients must have a clinical performance of Eastern Cooperative Oncology Group 0 or 1.\n7. Patients are considered medically fit enough by investigator to undergo all study procedures and interventions.\n8. Patients with documented left ventricular ejection fraction (LVEF) of ≥45%.\n9. Patients with documented forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) ≥50% tested by a pulmonary function test.\n10. Patients must be seronegative for HIV antibody (patients who are HIV seropositive may be less responsive and more susceptible to toxicities related to this experimental treatment since they may have a decreased immune competence).\n11. Patients must be seronegative for active hepatitis B (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test), and seronegative for hepatitis C (HCV) antibody. Patients with a history of hepatitis B virus (HBV) infection and having a negative HBsAg test and a positive antibody to hepatitis B surface antigen (HBsAg) are eligible. Patients with the hepatitis C antibody test positive are eligible only if tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n12. Life expectancy ≥6 months.\n13. Patients who are of childbearing potential (postmenarcheal who has not reached a postmenopausal state and has not undergone surgical sterilization) or have partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 6 months after the last dose of IL-2.\n\nInclusion Criteria in the treatment phase:\n\n1. The disease must have progressed to the last standard therapy, including at least one prior line with ICB for the group of patients with tumors where ICB is approved, and no subsequent approved therapy is available, or the patients are unable\u002Funwilling to receive standard therapy, or no standard therapy exists for a particular disease.\n2. Patients must have a remaining measurable disease as defined by RECIST v. 1.1 criteria following tumor resection\u002Fbiopsy for NEXTGEN-TIL manufacturing.\n\n   Note: Lesions previously irradiated should not be selected as target lesions unless there has been demonstrated progression in those lesions.\n3. Patients must understand and voluntarily sign an informed consent document before any study-related assessments\u002Fprocedures being conducted.\n4. Patients must be able and willing to comply with the study visit schedule and protocol requirements.\n5. Patients must have a clinical performance of Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n6. Patients are considered medically fit enough to undergo all study procedures and interventions and adequate hematological, renal and hepatic functions defined by:\n\n   1. Haemoglobin ≥9.0 g\u002FdL.\n   2. An absolute neutrophil count ≥1000\u002Fmm3 without the support of filgrastim.\n   3. Platelets ≥ 100 x10⁹ \u002Fmm3.\n   4. PT and aPTT ≤1.5 x upper limit of normal (ULN, unless receiving therapeutic anticoagulation). Subjects receiving therapeutic anticoagulation (such as low-molecularweight heparin or warfarin) should be on a stable dose.\n   5. AST or ALT ≤3 x ULN. Patients with liver metastases must have AST and ALT ≤5.0 x ULN.\n   6. Total bilirubin \\\u003C2 mg\u002FdL. Patients with Gilbert's Syndrome must have a total bilirubin ≤3.0 mg\u002FdL.\n   7. Serum creatinine \\\u003C1.5 mg\u002FdL or measured creatinine clearance ≥50 ml\u002Fmin calculated using the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) × (weight in kg) × (0.85 if female)\u002F72 × (serum creatinine in mg\u002FdL).\n7. Patients must be seronegative for HIV antibody.\n8. Patients must be seronegative for active hepatitis B (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test), and seronegative for hepatitis C antibody. Patients with a history of hepatitis B virus (HBV) infection and having a negative HBsAg test and a positive antibody to hepatitis B surface antigen (HBsAg) are eligible. Patients with the hepatitis C antibody test positive are eligible only if tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n9. Life expectancy ≥3 months.\n10. Patients who are of childbearing potential (postmenarcheal who has not reached a postmenopausal state and has not undergone surgical sterilization) or have partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 6 months after the last dose of IL-2.\n11. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Women of non-childbearing potential (WONCBP).\n    2. Women of childbearing potential (WOCBP), who:\n\n    i. Agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year from screening until 6 months after the infusion of the NEXTGEN-TIL product. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal occlusion, male sterilization, and copper intrauterine devices.\n\n    ii. Have a negative pregnancy test (blood) within one week before the first study treatment administration (applicable to premenopausal women and women ≤2 years after the start of menopause (menopause is defined as amenorrhea for \\\u003C2 years).\n12. Male Participants: during the treatment period and for at least 2 months after the last dose of study treatment, agreement to:\n\n    1. Remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom or a contraceptive method that result in a failure rate of \\\u003C1% per year, with partners who are WOCBP.\n    2. Refrain from donating sperm during the study.\n    3. Inform if his partner gets pregnant during this time.\n13. Any toxicity related to prior systemic therapy must have recovered to grade 1 or less according to NCI-CTCAE v5.0 at least 4 weeks before treatment enrollment, except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy, and Grade ≤2 peripheral neuropathy.\n\n    Note: Other Grade 2 AEs that are deemed clinically insignificant by treating physician and in consultation with Medical Monitor are permitted.\n14. Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.\n\nExclusion Criteria (any phase):\n\n1. Patients with symptomatic and\u002For untreated brain metastases. Note: Patients with definitively-treated brain metastases will be considered for enrollment after discussion with Medical Monitor; if, prior to the start of NMA-LD the patient is clinically stable for ≥3 months, there are no new brain lesions via magnetic resonance imaging (MRI) post-treatment, and the patient does not require corticosteroid treatment \\>10 mg prednisone or equivalent per day.\n2. Patients with leptomeningeal carcinomatosis.\n3. Patients with an active concurrent or history within the past 3 years of invasive malignancy, except for non-melanoma skin cancer, cervical and bladder carcinoma in situ, good prognosis ductal carcinoma in situ of the breast, or prostate carcinoma that is in remission under androgen deprivation therapy for \\> 2 years. Other exceptions may apply and require discussion between the Investigator and the Medical Monitor.\n4. Patients with an active systemic infection requiring anti-infective treatment within 14 days before preparative lymphodepleting therapy.\n5. Patients with active hepatitis B or hepatitis C.\n6. Patients with active autoimmune disease requiring immunosuppressive treatments.\n7. Patients with a history of organ or bone marrow transplantation.\n8. Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n9. Patients requiring regular treatment with steroids at a dose higher than prednisone 10 mg\u002Fday (or equivalent).\n\n   Note: use of inhaled, topical steroids and use of systemic physiologic corticosteroid replacement therapy are permitted.\n10. Patients with current or history within the last 6 months, as determined by the Investigator, of clinically significant, progressive, and\u002For uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.\n11. Patients with a history of coronary revascularization or ischemic symptoms.\n12. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin)\n13. Patients with allergies to any of the compounds included in any of the treatment products.\n14. Patients with contraindications for cyclophosphamide, fludarabine and IL-2 at per protocol doses.\n15. Patients who have received any approved anti-cancer cytotoxic, anti-angiogenic and ICB therapy including radiotherapy within 4 weeks before preparative lymphodepleting therapy. Exception: palliative radiotherapy for bone metastasis \\>2 weeks before preparative lymphodepleting therapy, denosumab, bisphosphonates, androgen deprivation therapy for prostate cancer and hormonal therapy for breast cancer.\n16. Patients who have received any non-cytotoxic drug and molecular targeted therapy within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).\n17. Patients who have received any investigational agent within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).\n18. Patients who have received a live, attenuated vaccination within the 4 weeks before lymphodepleting therapy.\n19. Patients who have undergone major surgery in the previous 3 weeks before lymphodepleting therapy.\n20. Patients who have previously received any investigational cell or gene therapies.\n21. Women of childbearing potential who are pregnant or breastfeeding.\n22. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.",{"count":131,"type":22},[207],"Background:\n\nThe presence of T-lymphocytes in resected tumor samples derived from long-term survival patients and the fact that reinvigoration of their functionality through the administration of specific immune-therapies can lead to remarkable antitumor responses supports that lymphocytes play a critical role in cancer immunity.\n\nAdoptive cell therapy using tumor-infiltrating lymphocytes product (TIL-ACT) is a well-established combination therapy currently under study in several world reference centers, using an autologous cell product without genetic modifications. This cell product consists of tumor-infiltrating lymphocytes (TIL), which are collected from the patient and expanded in the lab under specific conditions to enhance its antitumoral efficacy before reinfusion in the same patient. However, this cell product alone does not achieve adequate efficacy, and a combination of both previous non-myeloablative lymphodepleting (NMA-LD) chemotherapy and subsequent cytokine therapy (specifically IL-2) is needed to support the expansion of the infused cells.\n\nThe investigators hypothesize that TILs enriched for neoantigen recognition are superior to unselected TILs at mediating tumor regression in patients with epithelial tumors and even other solid tumors where immune checkpoint blockade (ICB) is approved and used as part of standard therapy. The investigators propose to manufacture a T-cell product composed of TILs that are selected based on their ability to recognize patient-specific neoantigens and to use these to treat patients with metastatic, refractory, epithelial cancers, as well as ICB-resistant solid tumors. Furthermore, it also proposed to study the tumor and T cells at baseline and after treatment to investigate whether specific phenotypic and functional traits may be associated with clinical outcome.\n\nPrimary objective:\n\nTo evaluate the safety and the tolerability of ex vivo next generation neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) in patients with metastatic or unresectable epithelial tumors and immune checkpoint blockade (ICB) resistant solid tumors.\n\nSecondary objectives:\n\n* To determine the success in producing active specific TILs from our target patients.\n* To evaluate the initial clinical activity of the NEXTGEN-TIL products in our target patients.",[338,28],"Epithelial Tumors, Malignant",[340,341,342],"Immune checkpoint blockade resistant tumors","Tumor-infiltrating Lymphocyte","Adoptive Cell Therapy","2024-11-06",{"date":345,"type":33},"2024-11-07",{"date":347,"type":33},"2021-10-28",{"date":349,"type":22},"2027-01-01",{"name":351,"class":96},"Vall d'Hebron Institute of Oncology"]