[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,44,69,104,136,159,184,207,233,253,290,319,340,381,405,436,465,498,525],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100512874","phase-1-ima402-t-cell-engaging-receptor-molecule-tcer-in-recurrent-andor-refractory-solid-tumors-100512874",false,"NCT05958121","IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and\u002For Refractory Solid Tumors","A Phase I\u002FII First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and\u002For Refractory Solid Tumors","Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients must have a specific pathologically confirmed and documented advanced and\u002For metastatic solid tumor indication\n* Patients must have received or not be eligible for indicated standard-of-care treatments per cohort\n* Measurable disease according to RECIST 1.1\n* Confirmed HLA status\n* ECOG Performance Status of 0 to 1\n* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status\n\nExclusion Criteria:\n\n* Other active malignancies that require treatment or that might interfere with the trial endpoints\n* The patient is pregnant or is breastfeeding\n* History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product\n* The patient has concurrent severe and\u002For uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures\n* Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and\u002For refractory solid tumors.\n\nPrimary objectives:\n\n* To determine the maximum tolerated doses and\u002For recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)\n* To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I\u002FII)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n\nSecondary objectives:\n\n* To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n* To describe the PK of IMA402 as monotherapy and in combination (Phase I\u002FII)",[27,28,29,30],"Refractory Cancer","Recurrent Cancer","Solid Tumor, Adult","Cancer","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2023-08-09",{"date":39,"type":20},"2027-09",{"name":41,"class":42},"Immatics Biotechnologies GmbH","INDUSTRY",29,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100401698","phase-2-study-of-pembrolizumab-with-bendamustine-in-hodgkin-lymphoma-100401698","NCT04510636","Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma","Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed\u002FRefractory Hodgkin Lymphoma","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial and adhere to trial procedures.\n* Be age ≥18 years at the time of signing informed consent.\n* Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve CR or PR to most recent therapy) classical Hodgkin Lymphoma (RR HL).\n* Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline, i.e. ABVD or BEACOPP.\n* Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT (as per institutional criteria).\n* May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.\n* May have received a prior autologous stem cell transplant but must be at least ≥100 days post-auto-transplant, and all transplant- related adverse events must have resolved to a grade 1 or less, and patients are not on immunosuppression, and meet all other eligibility criteria.\n* Must have measurable or evaluable disease, as defined as at least one lesion that can be accurately measured in at least 2 dimensions by CT\u002FPET scan. The minimum measurement must be \\>15 mm in the longest dimension or \\>10 mm in the short axis. Baseline FDG-PET scan must be positive (i.e. FDG-avid HL). Measurements must be done within 28 days prior to trial inclusion..\n* Must have Eastern Cooperative Group (ECOG) performance status 0-1.\n* Must have an estimated life expectancy of greater than 90 days.\n* Demonstrate adequate organ and bone marrow function. All screening laboratory tests should be performed within 7 days of treatment initiation.\n* If FOCBP (defined as any female who has experienced menarche and who has not undergone surgical sterilization (i.e. hysterectomy or bilateral oophorectomy) and is not postmenopausal (menopause is defined as 12 months of amenorrhea in a woman over the age of 45 years in the absence of other biological or physiological causes), eligible patients must have a negative pregnancy test within 72 hours prior to the first dose of study treatment. If the urine test is positive, a serum pregnancy test will be required.\n* All participants must be willing to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug.\n* If male, and sexually active with FOCBP, must agree to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug.\n* Azoospermic male, or male and FOCBP who are continuously not heterosexually active, are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described.\n* Must be available for treatment, assessment and follow-up.\n\nExclusion Criteria:\n\n* There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine.\n* Patient receiving any other investigational agents, or on current treatment for RR HL, or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n\nNote: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.\n\n* Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, small molecule, or biologic agent within 4 weeks of the first dose of treatment, or who has not recovered (i.e., ≤Grade 1 or to baseline) from AEs due to a previously administered agent.\n* Patient has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study, or who has not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patient has received pembrolizumab, or another anti-PD1, or anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or anti-OX-40 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with disease progression whilst on therapy, or within 3 months of completion of this line of therapy, without intervening systemic therapy (including chemotherapy, antibody drug conjugates or other targeted agents).\n* Patient has received prior treatment with bendamustine, either as monotherapy or as part of a combination regimen.\n* Patient has undergone prior allogeneic hematopoietic stem cell transplant.\n* Patient has another concurrent active malignancy (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that has undergone potentially curative therapy), and must be disease-free and off treatment for \\> 3 years.\n* Patient has known active central nervous system or meningeal disease.\n* Patients with active or past documented autoimmune disease that has required treatment in the past 2 years.\n* Patient is receiving systemic steroid therapy at a dose of \\> 10 mg\u002Fday of prednisone (or equivalent) for 7 days prior to day 1 of study treatment.\n* Has an uncontrolled co-existing illness, including but not limited to: ongoing or active infection requiring systemic therapy; systemic congestive heart failure Class III or IV by NYHA criteria; unstable angina pectoris or cardiac arrhythmia; in patients status post allogeneic transplantation uncontrolled GVHD.\n* Patient has a history of (non-infectious) pneumonitis that has required steroid treatment, or concurrent active pneumonitis.\n* Patient is pregnant, or nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab and\u002For bendamustine.\n* Has a known history of Human Immunodeficiency Virus (HIV), active tuberculosis (TB, Mycobacterium tuberculosis), or active hepatitis B or hepatitis C.\n* Patient has received a live vaccine within 30 days prior to first dose of study drugs.\n* Patient is eligible for autologous or allogeneic stem cell transplant, unless patient has declined this, therefore rendering themselves ineligible for stem cell transplantation.",{"count":52,"type":20},40,[24],"This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.",[56,57,27],"Classical Hodgkin Lymphoma","Relapsed Cancer","2026-06-19",{"date":60,"type":35},"2026-06-23",{"date":62,"type":35},"2021-12-20",{"date":64,"type":20},"2026-11-01",{"name":66,"class":67},"University Health Network, Toronto","OTHER",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100564854","phase-1-a-study-to-investigate-safety-and-effectiveness-of-bgb-16673-in-combination-with-other-agents-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100564854","NCT06634589","A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1b\u002F2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","Key Inclusion Criteria:\n\n* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF\n* Confirmed diagnosis of a R\u002FR B-cell malignancy\n* Protocol-defined measurable disease\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab\n* Substudies 1, 3, and 4 Inclusion Criterion:\n\n  * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL\u002Fmin\n* Substudy 2 Inclusion Criteria:\n\n  * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression\n  * Adequate renal function as indicated by eGFR of ≥ 30 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Treatment-naive B-cell malignancies\n* Unable to comply with the requirements of the protocol\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively\n* Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening\n* Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period\n* Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab\n* Substudy 1 Exclusion Criterion:\n\n  * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)\n* Substudy 2 Exclusion Criterion:\n\n  * Participants who discontinued prior zanubrutinib treatment due to intolerance\n* Substudies 3 and 4 Exclusion Criteria:\n\n  * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment\n  * All participants with a prior allogeneic stem cell transplant\n  * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":77,"type":20},80,[23,24],"The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R\u002FR) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.",[81,57,27,82],"B-cell Malignancy","B-cell Lymphoma",[84,85,86,87,88,89,90,91,92,93],"R\u002FR B-Cell Malignancies","relapsed or refractory B-Cell Malignancies","B-Cell malignancy","BGB-16673","sonrotoclax","zanubrutinib","B-cell lymphoma","Bruton Tyrosine Kinase (BTK)","Mosunetuzumab","Glofitamab","2026-06-01",{"date":96,"type":35},"2026-06-03",{"date":98,"type":35},"2024-11-27",{"date":100,"type":20},"2029-12-02",{"name":102,"class":42},"BeOne Medicines",50,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100338413","phase-1-actengine-ima203ima203cd8-as-monotherapy-or-in-combination-with-nivolumab-in-recurrent-andor-refractory-solid-tumors-100338413","NCT03686124","ACTengine® IMA203\u002FIMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and\u002For Refractory Solid Tumors","Phase 1\u002F2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer\u002FGermline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and\u002For Refractory Solid Tumors","ACTengine","Inclusion Criteria:\n\n* Patients must have recurrent\u002Fprogressing and\u002For refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* HLA-A\\*02:01 positive\n* For patients with ovarian\u002Ffallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.\n* Measurable disease according to RECIST 1.1\n* Adequate selected organ function per protocol\n* Patient's tumor must express tumor antigen by \"IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.\n* Life expectancy more than 5 months\n* Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203\u002FIMA203CD8\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203\u002FIMA203CD8\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.\n* History of cardiac conditions as per protocol\n* Prior stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Patients with LDH greater than 2.0-fold ULN.\n* Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and\u002For IMA203\u002FIMA203CD8 treatment\n* Patients with active brain metastases\n* Concurrent treatment in another clinical trial.\n* For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1\u002FPD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply",{"count":113,"type":20},375,[23,24],"The study's purpose is to establish the safety and tolerability of IMA203\u002FIMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).",[27,28,29,30],[118,119,120,121,122,123,124,125],"T-cell therapy","immunotherapy","Melanoma (Skin)","Melanoma, Uveal","Ovarian Carcinoma","Uterine Carcinoma","Uterine Carcinosarcoma","Immatics","2026-05-12",{"date":128,"type":35},"2026-05-13",{"date":130,"type":35},"2019-05-14",{"date":132,"type":20},"2032-06",{"name":134,"class":42},"Immatics US, Inc.",21,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100504775","phase-2-safety-and-efficacy-of-epcoritamab-with-gemcitabine-dexamethasone-and-cisplatin-gdp-salvage-chemotherapy-in-relapsed-refractory-large-b-cell-lymphoma-100504775","NCT05852717","Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","A Phase II Trial Evaluating Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-2 within 28 days prior to registration.\n4. Histologically confirmed CD20+ relapsed large cell lymphoma according to the 5th edition of the WHO classification of the hematolymphoid tumors and the 2022 international consensus classification of mature lymphoid neoplasms. This includes de-novo and transformed from prior indolent B-cell NHL such as follicular lymphoma, or marginal zone lymphoma (33, 34). Subjects with high-grade B-cell lymphoma (HGBCL), NOS subtype, and high-grade B-cell lymphoma with c-MYC, Bcl2 and\u002For Bcl6 rearrangements (double or triple hit lymphoma) are eligible. Patients with primary mediastinal B-cell lymphoma, and T-cell histiocyte-rich B-cell lymphoma, primary cutaneous diffuse large B-cell lymphoma, leg type, Intravascular large B-cell lymphoma, Epstein-Barr virus-positive diffuse large B-cell lymphoma, NOS, Diffuse large B-cell lymphoma associated with chronic inflammation, and ALK-positive large B-cell lymphoma are eligible. Patients with Burkitt lymphoma or lymphoplasmacytic lymphoma are not eligible.\n5. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014).\n6. Have received at least 1 prior line of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy.\n7. Patients must be deemed eligible to proceed with stem cell transplantation (autologous or allogeneic) or CAR T-cell therapy per treating physician discretion. Prior autologous stem cell transplantation or CAR T-cell therapy is permitted if \\> 90 days have elapsed and the patient is deemed eligible for allogeneic stem cell transplantation or CAR T-cell therapy by the investigator. Prior allogeneic stem cell transplant recipients may be eligible if they do not have active or chronic GVHD and are not receiving immunosuppression for the prophylaxis or treatment of GVHD.\n8. Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET\u002FCT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET\u002FCT per the Lugano criteria.\n9. Archival tissue obtained within 2 years of signing consent is required if available and will be identified at screening and shipped prior to Cycle 2 Day 1. If archival tissue is not available, but the subject is undergoing a standard of care biopsy, fresh tissue from that standard of care biopsy may be used for eligibility. If a subject does not have archival tissue obtained within 2 years of signing consent or is not undergoing a standard of care biopsy, they are not eligible for the trial. Cytological or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases that has been decalcified is not acceptable.\n10. Demonstrate adequate organ function. All screening labs to be obtained within 21 days prior to registration. \\*Patients with bone marrow involvement will be eligible to participate in the study but must meet hematologic parameters.\n11. Life expectancy of ≥ 6 months, as determined by the enrolling physician or protocol designee.\n12. Females subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study treatment. If a urine test is done and it is positice ir cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Female subjects of childbearing potential and male subjects must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception.\n14. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab, or odronextamab.\n2. Known active central nervous system or meningeal involvement by large cell lymphoma at time of screening. Patients diagnosed with CNS disease who achieved and maintained CNS CR at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings).\n3. Contraindication to any drug contained in the combination therapy regimen (GDP).\n4. Known hypersensitivity or allergic reaction to epcoritamab or its' excipients.\n5. Use of any standard or experimental anti-large cell lymphoma therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \\\u003C 14 days prior to C1D1. NOTE: Prednisone up to 50 mg or equivalent for 5 days is permitted; palliative radiation is permitted only if on non-target lesions).\n6. Major surgery \\\u003C 14 days of Cycle 1 Day 1.\n7. Neuropathy Grade ≥ 2 (CTCAE v.5.0).\n8. Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumours curatively treated with no evidence of disease for at least 3 years.\n9. Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic treatment within 7 days prior to the first dose of study treatment. Prophylactic antibacterial, antiviral, and antifungal agents are allowed.\n10. Active HIV infection. NOTE: Testing for HIV antibody is required at the time of screening. Those with positive HIV antibody will require HIV viral load by PCR testing. Patients with detectable viral load will not be eligible for the study. Those with positive antibody but undetectable viral load and CD4 \\>200 will be eligible.\n11. Testing for hepatitis B (HBV) and hepatitis C virus (HCV) is required at screening. Hepatitis B testing will consist of Hepatitis B surface Antigen (HBsAg), Hepatitis B Core Antibody (HBcAb) and Hepatitis Surface Antibody (HBsAb). Hepatitis C testing will consist of Hepatitis C Antibody (HCAb). Subjects with a history of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.\n12. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, or being compliant with the study procedures.",{"count":144,"type":20},32,[24],"Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. Each cycle will last 21 days. GDP consists of gemcitabine 1000 mg\u002Fm2 IV on Days 1 and 8, cisplatin 75 mg\u002Fm2 IV on Day 1, and dexamethasone 40 mg orally on Days 1 through 4. Epcoritamab will be administered subcutaneously (SC) on Days 1, 8, and 15. Patients will receive granulocyte colony stimulating factor (G-CSF) between Day 8 through Day 10 of each cycle of combination therapy.\n\nPatients will then undergo radiology imaging for disease assessment. Patients may proceed to SCT(autologous or allogeneic) or CAR T-cell therapy or epcoritamab monotherapy upon completion of Cycle 3 per investigator discretion. The rationale for subjects not proceeding to autoSCT or CAR T-cell therapy will be captured in the eCRFs.\n\nPatients who do not undergo SCT or CAR T-cell therapy may have the option to receive study treatment with epcoritamab monotherapy following completion of Cycle 3. Epcoritamab monotherapy will be offered to selected subjects who become ineligible to undergo SCT or CAR T-cell therapy (such as social situation, change in subject decision). The decision to offer epcoritamab monotherapy will be per investigator's discretion. However, subjects must have demonstrated a response to the combination therapy (partial remission or complete remission) per disease assessment scans prior to offering epcoritamab monotherapy. Epcoritamab monotherapy should begin 2 weeks following Cycle 3 Day 15. Monotherapy will consist of epcoritamab 48 mg administered subcutaneously on Days 1 and 15 of each 28 day cycle for Cycle 4 to Cycle 9 or until unacceptable toxicity, or disease progression per the Lugano Criteria.",[148,57,27],"Large Cell Lymphoma, Diffuse","2026-05-01",{"date":151,"type":35},"2026-05-06",{"date":153,"type":35},"2023-10-31",{"date":155,"type":20},"2028-11-24",{"name":157,"class":67},"Dipenkumar Modi",4,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":167,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100388419","phase-2-fatty-acid-synthase-inhibition-in-castration-refractory-prostate-cancer-100388419","NCT04337580","Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer","A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer","FASN","Inclusion Criteria:\n\n* Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting\n* Cancer Progression as defined by prostate cancer working group 3 (PCWG3) any type- prostate specific antigen only, bone only +nodal, nodal only or new lesions\n* Age 18 or older.\n* ECOG 0, 1, or 2\n* Life expectancy of greater than 2 months\n* Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for three (3) months after study treatment discontinuation.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).\n* Organ \\& marrow function as defined below: Absolute neutrophil count \\>1,200\u002FmcL, Platelets \\>75,000\u002FmcL; total bilirubin = within normal institutional limits; AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal; creatinine \\\u003C2.5 X institutional upper limit of normal\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","MALE",{"count":103,"type":20},[24],"The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.",[172,27,173],"Prostate Cancer","Castration Resistant Prostatic Cancer","2026-04-09",{"date":176,"type":35},"2026-04-13",{"date":178,"type":35},"2021-03-05",{"date":180,"type":20},"2028-03",{"name":182,"class":67},"Wake Forest University Health Sciences",2,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":68},"100491597","phase-2-zanubrutinib-with-pemetrexed-to-treat-relapsedrefractory-primary-and-secondary-central-nervous-system-cns-lymphomas-100491597","NCT05681195","Zanubrutinib With Pemetrexed to Treat Relapsed\u002FRefractory Primary and Secondary Central Nervous System (CNS) Lymphomas","Zanubrutinib With Pemetrexed for the Treatment of Relapsed\u002FRefractory Primary and Secondary CNS Lymphomas: A Phase II Trial With a Safety Lead-In","Inclusion Criteria:\n\n1. Any of the following diseases histologically confirmed:\n\n   1. Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease\n   2. Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease\n   3. Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma.\n2. Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)\n3. Progressed during first-line chemotherapy and\u002For radiotherapy -OR- insufficient clinical response to previous therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as Grade 3+ acute kidney injury (AKI) and\u002For transaminase elevation according to CTCAE v 5.0 criteria preventing repeat treatment exposure OR prior glucarpidase use due to high dose methotrexate delayed clearance and\u002For toxicity OR those who would have been glucarpidase candidates due to delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered or toxic plasma methotrexate concentrations (\\>1 micromole per liter) in patients with delayed methotrexate clearance) due to impaired renal function OR unable to receive high dose methotrexate induction on every 2 week +\u002F- 3 days schedule due to deconditioning and\u002FOR need for physical rehabilitation between the high dose methotrexate treatments\n4. No systemic lymphoma by positron emission tomography (PET) CT or CT scan of the chest, abdomen, and pelvis with contrast\n5. Adequate bone marrow and organ function demonstrated by:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   2. Platelets ≥ 75 x 10\\^9\u002FL and no platelet transfusion within the past 14 days prior to study enrollment\n   3. Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 14 days prior to study enrollment\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal\n   5. Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome\n   6. Creatinine Clearance (CrCl)\\> 45 mL\u002Fminute using Cockcroft-Gault formula\n6. Ability to understand and sign written informed consent prior to study entry unless the subject suffers from cognitive or physical impairment due to their CNS malignancy or due to a known underlying medical condition in which case consent could be signed by proxy\n7. Life expectancy of at least 2 months\n8. Females of childbearing potential must use highly effective method of contraception for the duration of the study and ≥ 30 days after the last dose of zanubrutinib. Female must also have a negative urine or serum pregnancy test ≤ 7 days before initial treatment.\n\n   * The investigator or a designated associate is requested to advise the patients how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Females using hormonal contraception should use barrier methods in addition.\n   * Male patients with a female partner of childbearing potential are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for up to one week after the last dose of zanubrutinib.\n\n   Agreement to use contraception during study participation\n   * Female patients of childbearing potential must practice highly effective methods of contraception.\n   * Male patients with female partners must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods. Acceptable contraception methods are included in the study protocol.\n   * Patients using hormonal contraceptives (e.g., birth control pills or devices) must use a barrier method of contraception (e.g., condoms) as well.\n9. For patients with Infectious disease, must have:\n\n   1. HIV positive with negative viral load and CD4 count \\> 400\n   2. Non-viremic Hepatitis C Virus (HCV)\n   3. HBcAb (Hepatitis B core positive) and HBsAg negative\n\nExclusion Criteria:\n\n1. Serious uncontrolled concurrent illness or comorbid condition\n2. Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer under observation. Patients with a remote history (3 years or more) of malignancy are eligible for the protocol in the absence of active disease\n3. Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol\n4. Unable to comprehend the study requirements or who are not likely to comply with the study protocol\n5. Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment\n6. Pregnant (confirmed by serum or urine β-HCG) or lactating\n7. Transaminases \\> 3 times above the upper limits of the institutional normal\n8. Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment with the exception of dexamethasone, or low dose prednisone with a total dose equivalent to 15 mg of prednisone a day or less for chronic conditions. Allogeneic stem cell transplant recipients as well as other organ transplant recipients are excluded. Autologous stem cell transplant recipients will qualify if relapse occurs at one year after the stem cell transplantation. Short course of dexamethasone up to 40 mg orally or intravenously daily with or without taper for CNS lymphoma symptom control is allowed.\n9. Patients should not have active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura).\n10. Non-healing wound, ulcer or bone fracture\n11. Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia\n12. Cerebrovascular accident or intracranial hemorrhage within 6 months of the study treatment; arterial or venous thrombotic or embolic event such as deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment. Patients with upper extremity catheter-related deep venous thrombosis will not be excluded.\n13. Concurrent use of warfarin or other vitamin K antagonists (need to be stopped 7 days prior to starting on trial drug)\n14. Infectious disease: HIV positive patients with positive viral load and CD4+ count \\\u003C 400 are excluded. HIV patients must have established and consistent infectious disease specialist care. HIV positive patients have to agree for every 12-week monitoring of viral load. Patients with the emergence of HIV viral load on the trial treatment will be referred to the infectious disease specialist and can continue on the trial treatment unless recommended to stop by the infectious disease specialist and PI. If the viral load reaches 100,000 copies per milliliter or above, the patient would be referred to an infectious disease specialist for and evaluation and would be taken off the trial.\n15. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable and if they are willing to undergo monitoring for HCV reactivation every 12 weeks. HCV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HCV viral load regardless of liver function tests (LFTs). Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n16. Patients with detectable hepatitis B surface antigen (HBsAg) are excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, are eligible if HBV DNA is undetectable and if they are willing to undergo monitoring for Hepatitis B Virus (HBV) reactivation every 12 weeks. HBV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HBV viral load regardless of LFTs. Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n17. Currently active, clinically significant cardiovascular disease including the following:\n\n    1. Myocardial infarction within 6 months before screening\n    2. Unstable angina within 3 months before screening\n    3. New York Heart Association class III or IV congestive heart failure\n    4. History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n18. Any uncontrolled active systemic infection or infection requiring systemic treatment that was completed ≤ 7 days before the first dose of therapy\n19. Participants who received a strong cytochrome P450 (CYP) 3A inhibitor or inducer within 7 days prior to the first dose of protocol anti-fungal prophylaxis, or participants who require continuous treatment with a strong CYP3A inhibitor\u002Finducer (i.e., except for any medication to be specifically mentioned in this protocol)\n20. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety, or put the study at undue risk. Participants with suspicious radiologic evidence of aspergillosis infection (i.e., chest CT and\u002For brain MRI) will not be eligible unless confirmatory laboratory testing of Beta-D glucan and aspergillus antigen are negative\n21. Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma\n22. Vaccination with a live or attenuates vaccine within 28 days prior to the first dose of zanubrutinib. Live or attenuated vaccines are not allowed during treatment with zanubrutinib\n23. Hypersensitivity to zanubrutinib or pemetrexed or any of the other ingredients of the applicable study drug",{"count":192,"type":20},15,[24],"This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.",[196,197,57,27],"Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","2026-03-02",{"date":200,"type":35},"2026-03-03",{"date":202,"type":35},"2024-04-25",{"date":204,"type":20},"2033-02",{"name":206,"class":67},"Baptist Health South Florida",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":68},"100523465","phase-1-autologous-car-t-cells-targeting-cspg4-in-relapsedrefractory-hnscc-100523465","NCT06096038","Autologous CAR-T Cells Targeting CSPG4 in Relapsed\u002FRefractory HNSCC","Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.",{"count":215,"type":20},33,[23,24],"The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.",[219,220,221,27],"Head and Neck Cancer","Relapse","Recurrent",[223],"cellular therapy","2026-02-18",{"date":226,"type":35},"2026-02-20",{"date":228,"type":35},"2024-04-05",{"date":230,"type":20},"2028-08-01",{"name":232,"class":67},"UNC Lineberger Comprehensive Cancer Center",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":158},"100394860","phase-1-pembrolizumab-ibrutinib-and-rituximab-in-pcnsl-100394860","NCT04421560","Pembrolizumab, Ibrutinib and Rituximab in PCNSL","A Phase Ib\u002FII Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory\u002FRelapsed Primary Central Nervous System Lymphoma (PCNSL)","Inclusion Criteria:\n\n* Participant must be able to understand and willing to sign a written informed consent document.\n* Participant must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n* Participant must be at least 18 years old on day of signing informed consent.\n* Subjects with pathologically confirmed PCNSL who progressed after CNS-directed therapy, primary refractory disease and relapsed disease are allowed. Participants should have evidence of R\u002FR disease on MRI or CSF cytology. Ocular only recurrences are allowed.\n* Subjects must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Life expectancy of \\>3 months (in the opinion of the investigator)\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1\n* Must be able to tolerate lumbar puncture and\u002For Ommaya taps\n* Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation.\n\n  * Hematology\n\n    * White Blood Count (WBC) ≥ 2 K\u002FμL\n    * Platelet count ≥ 100 K\u002FμL\n    * Absolute Neutrophil Count ≥ 1.5 K\u002FμL\n    * Hemoglobin \\> 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n  * Biochemistry\n\n    * Serum creatinine ≤1.5 x institutional ULN OR Measured or calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN (Creatinine clearance should be calculated per institutional standard)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN(≤5 × ULN for participants with liver metastases)\n    * Total bilirubin (TBILI) ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of \\\u003C 3.0 x institutional ULN) OR Direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN)\n  * Coagulation studies\n\n    * INR OR PT and Activated aPTT ≤1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test within 72 hours prior to registration.\n* Women in the following categories are not considered WOCBP:\n\n  * Premenarchal\n  * Premenopausal female with 1 of the following:\n\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n    * Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.\n  * Postmenopausal female: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n    * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n  * Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study discontinuation.\n\n  * 1\\. Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of \\\u003C 1% per year when used consistently and correctly.)\n\n    * a. Combined (estrogen- and progestogen- containing) hormonal contraception b, c\n\n      * i. Oral\n      * ii. Intravaginal\n      * iii. Transdermal\n      * iv. Injectable\n    * b. Progestogen-only hormonal contraception b, c\n\n      * i. Oral\n      * ii. Injectable\n  * 2\\. Highly Effective Methods That Have Low User Dependency (Failure rate of \\\u003C1% per year when used consistently and correctly)\n\n    * a. Progestogen- only contraceptive implant b, c\n    * b. Intrauterine hormone-releasing system (IUS) b\n    * c. Intrauterine device (IUD)\n    * d. Bilateral tubal occlusion\n    * e. Vasectomized partner: A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n    * f. Sexual abstinence: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n  * NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.\n\n    * Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).\n    * If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study discontinuation after the last dose of study treatment.\n    * If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.\n* Male participants must agree to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy:\n\n  * 1\\. Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n  * 2\\. Use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year as described in Eligibility criterion 3.1.13 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.\n  * a. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not be eligible for admission into the study.\n\n* Patients who cannot undergo MRI brain\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40,CD137)\n* Previously progressed on ibrutinib or other BTK inhibitor use (patient who have previously received BTK inhibitor but not progressed while on it are allowed)\n* Patients with \\> Grade 2 intracranial hemorrhage\n* Concomitant warfarin, any other warfarin-derivative anticoagulant, vitamin K antagonists, within 7 days before starting treatment. Note: novel oral anticoagulants (NOACs, e.g., Apixaban, Dabigatran, Edoxaban, Rivaroxaban), low molecular weight heparin (LMWH) are allowed\n* Arterial thromboembolic events such as cerebrovascular accident within 3 months before the start of study treatment\n* Active autoimmune disease requiring immunosuppressive agents or steroids (prednisone \\>10mg or equivalent)\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Requires treatment for PCNSL with high dose systemic corticosteroids defined as dexamethasone \\> 4 mg\u002Fday or bioequivalent for \\>3 consecutive days within 2 weeks of registration\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to dosing. OR 5 half-lives, whichever is shorter --- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with≤Grade 2 neuropathy may be eligible.\n* Patients who underwent major surgery ≤ 2 weeks before starting study treatment are excluded. If participant underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. Patients who plan to undergo surgery within 2 weeks of first dose of study treatment are excluded.\n* Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. Has received prior radiotherapy to CNS disease within 2 weeks of start of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella,varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has severe hypersensitivity (≥ Grade 3) to study agents and\u002For any of its excipients.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Patient is known to have an uncontrolled active systemic infection (\\>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug.\n* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association \\> Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Uncontrolled hypertension despite optimal medical management (per investigator's assessment).\n* Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin \\>8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of \\>8%.\n* Non-healing wound, ulcer or bone fracture.\n* Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Concurrent administration of medications or foods that are moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A4\u002F5 (need to be discontinued 2 weeks before starting study treatment)\n* Enzyme-inducing antiepileptic drugs (EIAED) need to be discontinued and switched to a non-EIAED 2 weeks prior to starting on trial drugs\n* Has known history of HIV\u002FAIDS\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)\n* Patients who have undergone prior allogeneic stem cell transplant\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment",{"count":241,"type":20},37,[23,24],"This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL).\n\nThe three drugs being used in the study are:\n\n* Pembrolizumab (MK3475)\n* Ibrutinib\n* Rituximab (or biosimilar)",[196,28,27,57],[196,28,27,57],{"date":226,"type":35},{"date":248,"type":35},"2020-08-01",{"date":250,"type":20},"2027-01-05",{"name":252,"class":67},"Dana-Farber Cancer Institute",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100532119","phase-1-optimal-precision-therapies-to-customise-care-in-childhood-and-adolescent-cancer-100532119","NCT06208657","Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer","Inclusion Criteria:\n\n1. Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists.\n2. Age \\\u003C21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent\u002Frefractory malignancy.\n3. Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).\n4. Patients enrolled in a Phase I cohort must have either evaluable or measurable disease.\n5. Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type.\n6. Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for evaluation.\n7. Performance status: Karnofsky performance status (for patients \\> 16 years of age) or Lansky play score (for patients ≤ 16 years of age) ≥ 50%.\n8. Life expectancy ≥ 6 weeks.\n9. Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment.\n10. Adequate organ function.\n11. Able to comply with scheduled follow-up and with management of toxicity.\n12. Females of childbearing potential must have a negative serum or urine pregnancy test.\n13. Fertile males must agree to use adequate contraception during the study and following completion of treatment.\n14. Provide a signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) - only for arms that include orally administered therapeutic agents.\n3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening.\n4. Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n5. Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered.\n6. Known hypersensitivity to any study drug or component of the formulation.\n7. Pregnant or nursing (lactating) females.\n8. Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the investigational drug(s).","0 Years","21 Years",{"count":262,"type":20},90,[23,24],"A companion platform trial to test novel targeted agents based on the patient's tumor profile.",[266,267,268,28,27],"Childhood Cancer","Childhood Solid Tumor","Childhood Brain Tumor",[270,271,272,273,274,275,276,277,278,279],"children","basket trial","platform study","pediatric","solid tumor","paediatric","solid tumour","CNS tumor","CNS tumour","lymphoma","2026-01-26",{"date":282,"type":35},"2026-01-28",{"date":284,"type":35},"2024-07-10",{"date":286,"type":20},"2035-12",{"name":288,"class":67},"Australian & New Zealand Children's Haematology\u002FOncology Group",14,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":307,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100505102","phase-1-phase-1-study-evaluating-the-safety-and-pk-of-adu-1805-in-advanced-solid-tumors-100505102","NCT05856981","Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors","An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Male or female aged ≥18 years\n* Signed and dated informed consent form\n* Measurable disease according to RECIST (Safety Expansion only)\n* ECOG Performance status of 0 or 1\n* Adequate organ and marrow function\n* Escalation Phase: Histologically and\u002For cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists\n* Expansion Phase: histologically and\u002For cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed\u002Frefractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST\n\nExclusion Criteria:\n\n* Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)\n* Expansion Phase:\n\n  * \\> 3 lines of prior systemic treatments\n  * MSS colorectal cancer (CRC): liver metastasis present\n* Pregnancy or breast-feeding\n* Prior treatment with or receipt of:\n\n  * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805\n  * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.\n  * anti-SIRPα or anti-CD47-directed therapy\n  * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805\n  * other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805\n  * vaccine containing live virus within 28 prior to the first dose of ADU-1805\n* Active untreated brain metastases\n* Active infection requiring systemic therapy\n* Impaired cardiac function or clinically significant cardiac disease\n* Current Grade \\>2 toxicity related to prior anti-cancer therapy\n* History of drug-induced severe immune-related adverse reaction\n* Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients\n* Major surgery within defined period\n* Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis\n* Allogenic tissue\u002Fsolid organ transplant\n* Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study",{"count":298,"type":20},130,[23],"This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).",[29,302,27,303,304,305,306],"Metastatic Solid Tumor","CRC, Colorectal Cancer","RCC, Clear Cell Adenocarcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Endometrial Cancer",[308],"Immunotherapy","2025-12-09",{"date":311,"type":35},"2025-12-17",{"date":313,"type":35},"2023-04-03",{"date":315,"type":20},"2027-07",{"name":317,"class":42},"Sairopa B.V.",7,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":68},"100535380","phase-4-plan-development-for-giving-teclistamab-in-the-outpatient-setting-100535380","NCT06251076","Plan Development for Giving Teclistamab in the Outpatient Setting","Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed\u002FRefractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden","Multiple Myeloma Patients to Receive Outpatient Teclistamab (Part 1):\n\nInclusion Criteria:\n\n1. Eligible for teclistamab treatment as per Health Canada approved indication:\n\n   1. Age 18 and greater\n   2. Relapsed or refractory multiple myeloma\n   3. Received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody\n   4. Demonstrated disease progression on the last therapy\n2. For Cohorts 1 and 2, participants must agree to receive treatment at Princess Margaret Cancer Centre. For Cohort 3, participants must agree to receive treatment at Stronach Regional Cancer Centre.\n3. Must sign the informed consent form (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.\n4. Have one or more caregivers meeting study criteria.\n5. Have clinical laboratory values meeting study criteria.\n6. Rockwood Clinical Frailty Scale - threshold score ≤ 5\n7. A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and must agree to:\n\n   1. Practicing true abstinence; or\n   2. Have a sole partner who is vasectomized; or\n   3. Practicing ≥1 highly-effective, user-independent method of contraception.\n8. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study. Upon study end, female participants must agree to continue with product monograph guidelines with ongoing teclistamab off-study.\n9. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study, and thereafter to continue with product monograph guidelines. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the study, and thereafter to follow product monograph guidelines with ongoing teclistamab off-study.\n\nExclusion Criteria:\n\n1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.\n2. Prior or concurrent exposure to any of the following:\n\n   1. Teclistamab or any anti-BCMA therapy\n   2. Other myeloma therapy (standard of care or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab\n3. Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n4. High risk disease features including:\n\n   1. Central nervous system (CNS) involvement with myeloma\n   2. Extramedullary disease (≥1 soft tissue plasmacytoma not associated with bone)\n   3. Circulating plasma cells (plasma cell leukemia)\n   4. Rapidly progressive disease, as per investigator assessment\n5. Concurrent disorders, including:\n\n   e. Light chain amyloidosis f. Second malignancy requiring active therapy, exceptions including prostate cancer receiving androgen deprivation therapy or adequately treated breast cancer carcinoma on anti-hormonal agents and considered to have a very low risk of recurrence g. Underlying neurologic dysfunction (history of seizure, Cerebrovascular Accident (CVA) or Transient ischemic attack (TIA), intracranial hemorrhage, dementia or other cognitive impairment) h. Hepatitis B infection (HBV-DNA positive). Patients with HepBsAg (Surface antigen of Hepatitis B virus) or HepBcAb (Hepatitis B viral protein) positive are allowed on study, only if on antiviral prophylaxis and HBV-DNA viral load is undetectable.\n\n   i. Active infection requiring anti-infective therapy (prophylactic antibiotics are allowed). Cytomegalovirus (CMV) IgG (Immunoglobulin G) positivity allowed, but must be CMV PCR (Polymerase Chain Reaction) negative.\n\n   j. Underlying coagulopathy that may increase the risk of bleeding in the setting of cytopenia.\n6. Presence of the following cardiac conditions:\n\n   1. New York Heart Association stage III or IV congestive heart failure\n   2. Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization\n   3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n   4. History of severe non-ischemic cardiomyopathy\n7. Major surgery within 2 weeks prior to the start of administration of study treatment (kyphoplasty or vertebroplasty are not considered major surgery).\n8. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n\n   1. Uncontrolled diabetes\n   2. Acute diffuse infiltrative pulmonary disease\n   3. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy\n   4. History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing\n   5. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status\n   6. Other comorbidities felt by treating physician to require hospitalization for teclistamab step-up dosing, such as poorly controlled pain despite use of narcotics, multiple concurrent comorbidities (diabetes, advanced age, cardiac disease)\n   7. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n   8. History of non-compliance with recommended medical treatments\n\nCaregivers of multiple myeloma subjects treated with outpatient-based teclistamab (Part 2):\n\nInclusion Criteria:\n\n1. Agree to be a caregiver for a participant with multiple myeloma enrolled in this study protocol to receive outpatient teclistamab (any of Cohorts 1, 2, 3)\n2. Age 18 and greater\n3. English-speaking\n4. Must sign an Informed consent form\n5. Attend mandatory orientation, equipment training, and provide transportation by car to and from Princess Margaret Cancer Centre until two days after completion of first three doses (at minimum 8 days to encompass step up dosing), and twice weekly to Day 27\n6. Accompany the participant through the night and during the day, with no more than 2-hour gaps during the day during which the patient is alone, to end of study (Day 27 or completion of 6 total doses \\[2 step up doses + 4 full doses\\], whichever is later). More than one caregiver may participate to fill the required hours of accompaniment.\n7. Agree to help administer home medications, buy groceries, prepare food and otherwise support the participant\n8. Agree and capable of monitoring the participants vital signs, apply the Immune Effector Cell Encephalopathy (ICE) score, record findings, and report to the study team (by phone or in person)\n\nExclusion Criteria:\n\n1. Not sufficiently comfortable or understanding of the use of vital sign equipment, applying the ICE score, or other caregiver requirements, as per Investigator discretion\n2. Unable to complete caregiver follow-up assessments at 30 and 90 days after last treatment subject dose.",{"count":192,"type":20},[328],"PHASE4","This is a pilot study to develop an outpatient-based process for the administration of teclistamab for for relapsed\u002Frefractory multiple myeloma patients and to evaluate the burden on caregivers of patients receiving outpatient administration of teclistamab.",[331,57,27],"Multiple Myeloma","2025-12-02",{"date":334,"type":35},"2025-12-10",{"date":336,"type":35},"2024-11-19",{"date":338,"type":20},"2026-10",{"name":66,"class":67},{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":370,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":318},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":348,"type":20},56,[23],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,27,369],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Solid Tumor",[352,353,354,355,357,358,359,360,361,362,363,364,365,366,367,368,27,371,372,373,369],"MQ710","Memorial Sloan Kettering Cancer Center","22-278",{"date":375,"type":35},"2025-12-03",{"date":377,"type":35},"2023-05-04",{"date":379,"type":20},"2028-05-04",{"name":372,"class":67},{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":183},"100530227","phase-1-a-dose-escalation-and-expansion-study-of-177lulu-sn201-in-participants-with-advanced-cancer-100530227","NCT06184035","A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer","Ph I\u002FIIa Escalation\u002FExpansion FIH, Open, Multi Center, Single Arm Study Evaluating Safety, Dosimetry and Early Efficacy of 177Lu-SN201 in Progressive\u002FTreatment-refractory, Locally Advanced, Unresectable Metastatic or Recurrent Solid Tumors","Tumorad","Inclusion criteria:\n\n1. Male or female participants ≥ 18 years of age on the day of signing informed consent.\n2. Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n4. Life expectancy ≥ 3 months.\n5. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within 28 days before the start of the study IMP administration:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL (transfusions are allowed).\n   2. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n   3. Platelet count ≥ 100,000 mm3.\n   4. Total bilirubin ≤ 2.5 x upper limit of normal (ULN) (in participants with liver metastases ≤ 5 ULN).\n   5. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 x ULN.\n6. On a stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and prothrombin\u002Finternational normalized ratio and partial thromboplastin time (PT\u002FINR and PTT, respectively) test results are compatible with the acceptable benefit-risk ratio at the Investigator's discretion.\n7. Serum creatinine ≤ 1.5 x ULN and estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin\u002F1.73 m2 (per local values).\n8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   1. Male participants must agree to use a highly effective method of birth control as defined in ICH M3(R2) starting with the first dose of study medication through 120 days after the last dose of study medication.\n   2. Female participants of childbearing potential\\* must have a negative pregnancy test documented at Screening and Baseline and be willing to use a highly effective method of contraception\\*\\* or practice abstinence starting from ICF signature through to 120 days after the last dose of study medication.\n\n      * A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., had had menses at any time in the preceding 24 consecutive months).\n\n        * Effective contraception is defined as contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, implantable\\], intrauterine device \\[IUD\\] or intrauterine hormone-releasing system).\n9. Written informed consent to study participation.\n10. Be able to understand and comply with the requirements of the study, as judged by the Investigator.\n11. Phase I: At least one lesion as per RECIST v1.1.\n12. Phase IIa: At least one measurable lesion as per RECIST v1.1.\n\nExclusion criteria:\n\n1. Unstable systemic disease (including but not limited to active infection, hepatic, renal, or metabolic disease).\n2. Clinically significant cardiac disease including any of the following:\n\n   1. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2).\n   2. LVEF of \\\u003C 50%, as determined by MUGA or ECHO.\n   3. Uncontrolled hypertension, defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.\n   4. History or presence of clinically significant ventricular arrhythmias or atrial fibrillation.\n   5. Clinically significant resting bradycardia.\n   6. Unstable angina pectoris ≤ 3 months before the start of study treatment.\n   7. Acute myocardial infarction ≤ 3 months before the start of study treatment.\n   8. Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value \\> 480 msec (as specified in Section 10.5).\n3. Known hypersensitivity to pegylated drugs or vaccines (e.g., covid-19 vaccines).\n4. Concurrent or active solid or hematologic malignancy within the last 2 years with a distinct primary site or histology from the cancer being evaluated in this study except for the following cancer types: cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis).\n5. Infections not responding to therapy or active clinically serious infections.\n6. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection requiring treatment. Participants with chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n\n   NB: Participants with CNS metastases may be included after discussion with Sponsor, except for the sentinel participants.\n7. Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration.\n8. Palliative radiotherapy completed less than 2 weeks before the start of the study IMP administration will be allowed as long as no more than 10% of the participant's bone marrow was irradiated.\n9. Not recovered to Grade 1 from any prior anti-cancer therapy, excluding alopecia.\n10. Previous high-dose chemotherapy needing hemopoietin-stem-cell-rescue.\n11. Major surgery, open biopsy, or significant trauma within 4 weeks before the start of study treatment.\n12. A psychiatric or functional disorder that prevents participants from providing informed consent or following protocol instructions.\n13. A participant that has a condition or is in a situation, in the Investigator's opinion may put the individual at significant risk, may confound the study results, or may interfere significantly with their participation in the study.\n14. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks or 5 half-lives of the agent, whichever is the shortest.",{"count":262,"type":20},[23,24],"The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \\[177Lu\\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options.\n\n\\[177Lu\\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.",[369,368,393,394,395,27],"Unresectable Solid Tumor","Recurrent Solid Tumor","Locally Advanced Solid Tumor","2025-11-17",{"date":398,"type":35},"2025-11-20",{"date":400,"type":35},"2023-12-06",{"date":402,"type":20},"2027-12-31",{"name":404,"class":42},"Spago Nanomedical AB",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":183},"100594250","phase-1-a-phase-i-first-in-human-study-of-cba-1535-t-cell-engager5t4cd35t4-in-patients-with-advanced-solid-tumors-100594250","NCT07016997","A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4\u002FCD3\u002F5T4) in Patients With Advanced Solid Tumors.","A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.","Inclusion Criteria:\n\n* Patients who provide voluntary written informed consent to participate in the study\n* ECOG performance status: \\\u003C= 1\n* Patients with 3 months or longer life expectancy\n* Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy\n\nExclusion Criteria:\n\n* Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment\n* Patients who received anti-cancer drug within 14 days prior to enrollment\n* Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug","20 Years",{"count":414,"type":20},70,[23],"This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535.\n\nThe study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab.\n\nThis study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.",[418,27],"Solid Tumors",[420,421,422,423,424,425,426],"CBA-1535","5T4","CD3","T cell Engager","Trophoblast Glycoprotein","Tribody","solid tumors","2025-06-04",{"date":429,"type":35},"2025-06-12",{"date":431,"type":35},"2022-06-27",{"date":433,"type":20},"2026-12",{"name":435,"class":42},"Chiome Bioscience Inc.",{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":21,"phases":445,"briefSummary":446,"conditions":447,"keywords":453,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":464},"100490692","phase-1-a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-combination-with-pembrolizumab-in-participants-with-solid-tumor-malignancies-100490692","NCT05669430","A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy\n* Refractory or intolerant to standard therapy(ies)\n* Must have received, be not eligible or decline standard of care therapy\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1\n* Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D\n* Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years\n* Laboratory test results within the required parameters\n* Women of child bearing potential (WOCBP) and men must agree to use adequate contraception\n* Parts B, C and D may include the following tumor types:\n\n  * Endometrial carcinoma\n  * Squamous head and neck carcinoma\n  * Cutaneous melanoma\n  * Non-small cell lung cancer\n  * Proficient MMR (pMMR)\u002FMSS adenocarcinoma of the colon or rectum (Parts C and D only)\n\nParts A, B, C and D Exclusion Criteria:\n\n* Participant with acute leukemia or CLL (Parts A and B only)\n* Participant with heart disease or unstable arrhythmia\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* History of major organ transplant\n* History of a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication\n* Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication\n* Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication\n* Radiation for symptomatic lesions must have been completed prior to the first dose of study medication\n* Participants with liver metastases unless approved by the Sponsor\n* Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1\n* Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)\n* Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and\u002For any of its excipients (Parts C and D only)\n* Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease (Parts C and D only)\n* Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)\n* Active substance abuse",{"count":444,"type":20},365,[23,24],"This is a Phase 1\u002F2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[29,27,448,449,450,451,452],"Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum","Cutaneous Melanoma","Non-Small Cell Lung Cancer",[454],"GV20-0251","2025-02-11",{"date":457,"type":35},"2025-02-13",{"date":459,"type":35},"2023-03-23",{"date":461,"type":20},"2027-09-05",{"name":463,"class":42},"GV20 Therapeutics",13,{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":260,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":21,"phases":475,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":496,"locationsCount":68},"100462467","phase-1-allogeneic-nkg2dl-targeting-car--t-cells-ctm-n2d-in-advanced-cancers-angelica-100462467","NCT05302037","Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)","A Phase I Trial to Evaluate Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) in Subjects With Advanced Solid Tumours or Haematological Malignancies (the ANGELICA Trial)","ANGELICA","Inclusion Criteria:\n\n* At least 21 years of age\n* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling, and analyses (if applicable, the written informed consent may include access to all archival tumour tissue, e.g., diagnostic and\u002For most recent samples for correlative study)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and an estimated life expectancy of greater than 12 weeks\n* Females of reproductive age group must be on effective contraception (if sexually active), must not be breast feeding and must have a negative pregnancy test prior to the start of lymphodepletion.\n* For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception (i.e., condoms) with all sexual partners. Where the sexual partner is a 'woman of child-bearing potential' who is not using effective contraception, the male patients must use a condom (with spermicide) during the study and for 6 months after the last dose of a study drug.\n* Adequate hepatic, renal and lung function as demonstrated by any of the following laboratory values:\n\n  * AST or ALT ≤ 3 x ULN\n  * Total bilirubin ≤ 1.5 x ULN\n  * Glomerular filtration rate (GFR) \\> 50 mL\u002Fmin, as assessed using the Cockroft-Gault formula or 24 h urine creatinine collection\n  * SpO2 on room air \\> 94%\n* Adequate bone marrow reserve as demonstrated by any of the following laboratory values:\n\n  * Absolute neutrophil count (ANC) ≥ 1.0x10\\^9\u002FL\n  * Platelet count ≥ 75 x 10\\^9\u002FL\n  * Haemoglobin ≥ 9.0 g\u002FdL\n* Patients must have a metastatic cancer resistant to or deemed unsuitable for at least two standard lines of cancer therapy regimens, as part of their management of recurrent\u002Fpersistent disease.\n* Presence of measurable tumour by RECIST 1.1 criteria\n* Serum 25 Hydroxyvitamin D total ≥ 20ng\u002Fml\n* Have a diagnosis of cancer that is known to express NKG2D ligands\n\nExclusion Criteria:\n\n* With the exception of alopecia, any unresolved toxicities from prior therapy ≥ the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 2\n* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to the start of lymphodepletion\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection including any patient known to have human immunodeficiency virus (HIV) or hepatitis virus. Screening for chronic conditions is not required.\n* All HBsAg-positive patients (For HBsAg-negative, but anti-HBc total-positive patients, HBV viral load will be further tested. If HBV viral load is negative, patients may be included.)\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Subjects without active disease in the last 5 years may be included but only after consultation with the medical monitor\n  * Subjects with celiac disease controlled by diet alone\n  * For other autoimmune or inflammatory conditions not specifically mentioned, discuss on case-by-case basis with investigator and medical monitor\n* Concurrent severe and\u002For uncontrolled medical condition (e.g., severe COPD, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition (screening for chronic disease is not required)\n* Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of contraception\n* Receiving, or having received during the four weeks prior the start of lymphodepletion, any investigational product\n* Treatment with any investigational biological product (e.g., immune check point blockers, antibodies, nanoparticles, experimental) during the four weeks prior the start of lymphodepletion\n* Patients who underwent major surgery during the four weeks prior to the start of lymphodepletion\n* Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) during the three weeks prior to the start of Lymphodepletion\n* Active infection requiring systemic long-term (\\> 2 weeks) treatment with antibiotics, antifungal or antiviral drugs\n* Cardiac dysfunction as defined as: Myocardial infarction within six months of study entry, NYHA Class II\u002FIII\u002FIV heart failure, unstable angina, unstable cardiac arrhythmias or reduced LVEF \\\u003C 50%.\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)\n  * Uncontrolled hypertension requiring clinical intervention\n* Failed dental clearance (for zoledronic acid administration)\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements\n\nSubject Withdrawal Criteria\n\nTreatment may continue until one of the following criteria applies:\n\n* Disease progression\n* Intercurrent illness that prevents further administration of treatment\n* Unacceptable adverse event(s)\n* Intolerable non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 2\n* Unmanageable hematologic or non-hematologic toxicities ≥ NCI CTCAE v5.0 Grade 3\n* General or specific changes in the patient's condition that renders the patient unsuitable for further treatment at the discretion of the investigator\n* Patient who cannot recover from adverse event(s) and lead to treatment delay for \\> 4 weeks\n* Patient who decides to withdraw from the study",{"count":474,"type":20},12,[23],"CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells.\n\nCurrently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy.\n\nCytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not.\n\nThe phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D.\n\nCTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.",[30,478,27,57],"Malignancy",[480,481,482,483,484,485,486,487,488,489,490],"cancer","malignancy","solid cancer","solid tumours","haematological cancer","haematological malignancy","refractory cancer","relapsed cancer","CAR-T","cell therapy","gamma delta","2024-11-20",{"date":493,"type":35},"2024-11-22",{"date":336,"type":35},{"date":433,"type":20},{"name":497,"class":42},"CytoMed Therapeutics Pte Ltd",{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":508,"phases":4,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":524},"100478038","precision-medicine-for-every-child-with-cancer-100478038","NCT05504772","Precision Medicine for Every Child With Cancer","ZERO2","Inclusion Criteria:\n\n1. Age \\\u003C 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.\n2. Life expectancy \\>6 weeks at time of enrolment\n3. Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent\u002Fguardian of participant aged \\\u003C18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.","25 Years",{"count":507,"type":20},3500,"OBSERVATIONAL","To improve outcomes for childhood cancer patients through the implementation of precision medicine.",[266,267,268,511,27,57],"Childhood Leukemia",[270,513,514,515,273,275],"precision medicine","personalised medicine","molecular profiling","2024-07-16",{"date":518,"type":35},"2024-07-17",{"date":520,"type":35},"2022-12-16",{"date":522,"type":20},"2030-07",{"name":288,"class":67},11,{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":533,"sex":16,"minAge":17,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":21,"phases":537,"briefSummary":538,"conditions":539,"keywords":545,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":68},"100533709","phase-2-leflunomide-or-combination-of-mek-inhibitor-and-hydroxychloroquine-for-refractory-patients-with-ras-mutations-100533709","NCT06229340","Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations","New Therapeutic Approaches for Tumors With RAS Gene Mutations","NТО-RAS","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Patient age is at least 18 years old.\n3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.\n4. Histologically confirmed metastatic metastatic disease stage 4.\n5. Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.\n6. More than 2 lines of standard drug antitumor therapy in the anamnesis.\n7. Must have disease progression as defined by RECIST version 1.1 criteria\n8. Appropriate hematologic and liver function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FμL)\n   * Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FμL)\n   * Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without transfusion\n   * Hemoglobin ≥ 90 g\u002FL without transfusion.\n   * Creatinine clearance ≥ 40 mL\u002Fmin\n   * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n   * Serum bilirubin ≤ 1.5 x HGH, with the following exception:\n   * Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH\n   * AST, ALT, and alkaline phosphate ≤ 2.5 x HGN;\n\n10\\. For women of childbearing potential: consent to abstinence (abstain from heterosexual intercourse) or use at least two forms of effective contraception with an ineffectiveness rate \\\u003C 1% per year during treatment.\n\n11\\. Patients with asymptomatic new or advanced brain metastases (active brain metastases) are eligible to participate if the treating physician determines that localized treatment is not required.\n\nExclusion Criteria:\n\n1. Age over 85 years.\n2. Рresence of acute or active chronic infections.\n3. Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \\\u003C 45%\n4. Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.\n5. History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs in the combination.\n6. Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or mental illness\u002Fsocial situations that limit study compliance.\n7. Patients should not be pregnant or breastfeeding due to the potential for teratogenic effects and side effects of planned chemotherapeutic regimens.\n8. History of retinal disease (retinal tear, exudate, hemorrhage) or retinal vein occlusion, central serous retinopathy or retinal pigment epithelium detachment, or current risk factors for ROS (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).\n\nExit criteria:\n\n1. Refusal to continue participation in the study.\n2. Intolerable toxicity.\n3. Progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment.\n4. Non-compliance with IND procedures.",true,"85 Years",{"count":536,"type":20},20,[24],"There is a huge variety of nucleotide substitutions that activate RAS. The search for new \"universal\" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies.\n\nThe use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.",[540,541,542,543,544,357,27],"RAS Mutation","Ras (Kras or Nras) Gene Mutation","Colorectal Cancer Recurrent","Pancreas Cancer","Lung Cancer",[540,541,546,543,357,544,27],"Colorectal Cancer","2024-01-19",{"date":549,"type":35},"2024-01-29",{"date":551,"type":35},"2023-10-03",{"date":553,"type":20},"2026-10-01",{"name":555,"class":67},"N.N. Petrov National Medical Research Center of Oncology"]