[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,139,0,25,[9,42,73,85,110,135,161,189,210,230,258,283,315,352,375,439,467,488,507,526,545,570,598,624,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053380","phase-1-a-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-lrk-4189-alone-and-in-combination-in-patients-with-solid-tumors-100053380",false,"NCT07498725","A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors","A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors","Inclusion Criteria:\n\n* Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.\n* Cancer can be measured on scans, such as CT or MRI.\n* Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.\n* Heart rhythm test (ECG) shows a normal result within safe limits.\n* Blood test results at screening are within an acceptable and stable range.\n* If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.\n* If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.\n\nExclusion Criteria:\n\n* Unable to swallow the study medication or your body cannot absorb it.\n* Have had a serious allergic reaction to LRK-4189 or any of its ingredients.\n* Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.\n* Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.\n* Currently receiving another cancer treatment.\n* Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.\n* Have an active infection that requires treatment through a vein (IV).\n* Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.\n* Pregnant or breastfeeding or planning to become pregnant or father a child during the study.\n* Cannot safely receive the standard chemotherapy that would be used with this study.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189.\n\nThe main questions it aims to answer are:\n\nIs LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors?\n\nParticipants will:\n\n* Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years.\n* Visit the clinic once every week for checkups and tests.",[28],"Neoplasms","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2026-07-07",{"date":37,"type":21},"2029-06",{"name":39,"class":40},"LARKSPUR BIOSCIENCES, INC.","INDUSTRY",3,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100053608","phase-2-multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100053608","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.","MALE","120 Years",{"count":52,"type":21},52,[25],"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[56,57,28,58,59,60],"Adenocarcinoma","Prostate Cancer","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[62],"Immune Infiltration","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":66,"type":21},"2026-07-16",{"date":68,"type":21},"2028-06-15",{"name":70,"class":71},"National Cancer Institute (NCI)","NIH",1,{"id":74,"slug":4,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":54,"conditions":77,"keywords":78,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":84,"locationsCount":72},"100641793",{"count":52,"type":21},[25],[56,57,28,58,59,60],[62],"2026-07-01",{"date":81,"type":33},"2026-07-02",{"date":35,"type":21},{"date":68,"type":21},{"name":70,"class":71},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":72},"100313872","phase-1-5-aza-4-thio-2-deoxycytidine-aza-tdc-in-people-with-advanced-solid-tumors-100313872","NCT03366116","5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors","Phase I Trial of 5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients With Advanced Solid Tumors","* INCLUSION CRITERIA:\n* Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy.\n* Age \\>=18 years of age.\n* ECOG performance status \\\u003C= 2.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\>= 1,500\u002FmcL\n  * platelets \\>=100,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (\\\u003C=3 x upper limit of normal in the presence of documented Gilbert s syndrome)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal\n\nOR\n\n* AST(SGOT)\u002FALT(SGPT) \\\u003C=5 X institutional upper limit of normal for patients with liver metastases\n* creatinine \\\u003C=1.5X institutional upper limit of normal\n\nOR\n\n* creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 1.5X institutional normal\n\n  * Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC.\n  * Patients must have completed any chemotherapy or biologic therapy \\>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \\>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Willingness to provide blood and urine samples for research purposes.\n  * Ability to swallow pills\u002Fcapsules.\n  * Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry.\n  * For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \\& N lesions under visualization) and willingness to undergo tumor biopsies.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents.\n* Pregnant women and women who are breastfeeding are excluded from this study.\n* Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1\n  * Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1\n    * Screening CNS radiographic study 2 weeks from completion of radiotherapy and \\>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up.\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption.",{"count":93,"type":21},65,[24],"Background:\n\nBlood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the \"instruction book\" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were \"turned off.\" Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC.\n\nObjective:\n\nTo test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans.\n\nEligibility:\n\nPeople ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nBlood and urine tests\n\nScans to measure their tumors\n\nTest to measure the electrical activity of the heart\n\nParticipants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long.\n\nWeek 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment.\n\nFor cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks.\n\nThe cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better.\n\nSponsoring Institute: National Cancer Institute\n\n...",[28,97],"Solid Tumors",[99,100,101,102,103],"Pharmacodynamics","DNA Methylation","Pharmacokinetics","Nucleoside Analog","Epigenetics",{"date":81,"type":33},{"date":106,"type":33},"2018-11-05",{"date":108,"type":21},"2026-09-30",{"name":70,"class":71},{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100614190","phase-1-two-part-study-of-nenocorilant-combined-with-nivolumab-in-patients-with-advanced-solid-malignancies-100614190","NCT07276373","Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","A Phase 1b\u002F2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death\u002F(Ligand) 1 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Signed and dated institutional review board (IRB)\u002F independent ethics committee (IEC)-approved informed consent form (ICF)\n* Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment\n* Has a life expectancy of ≥ 3 months\n* Has evaluable disease based on RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has adequate organ function\n* Negative serum or urine pregnancy test for female patients of childbearing potential\n* Agreement to use appropriate precautions to avoid pregnancy, unless the patient and\u002For their sole sexual partner is permanently sterilized\n\nExclusion Criteria:\n\nPart 1\n\n* Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\\[L\\]1) therapy that meet any of the following criteria:\n\n  1. Grade ≥ 3\n  2. Resulted in discontinuation of anti-PD(L)1 therapy\n* Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy\n* Medical history of adrenal insufficiency\n* Has had any major surgery within 4 weeks prior to the first dose of study treatment\n* Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator\n* Unable to swallow, retain, or absorb oral medication\n* Concurrent participation in another interventional clinical trial\n* Has toxicities due to prior therapies that are reversible and have not resolved\n* Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors\n* Has a known history of severe hypersensitivity to any of the study drugs, or other human\u002Fhumanized monoclonal antibodies\n* Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial\n* Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation\n* Known psychiatric disorder that would interfere with trial compliance\n* Has infection with HIV, hepatitis C virus, or hepatitis B virus\n* Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases\n* Has a history of another malignancy within 2 years prior to study treatment, unless cured\n* Has received prior autologous or allogeneic organ or tissue transplantation\n* A QTcF interval \\>450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval",{"count":118,"type":21},50,[24,25],"This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and\u002For optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.",[28],[123,97,124],"Advanced Solid Tumors","Solid Malignancies","2026-06-26",{"date":127,"type":33},"2026-06-30",{"date":129,"type":33},"2026-01-16",{"date":131,"type":21},"2027-01",{"name":133,"class":40},"Corcept Therapeutics",4,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":93},"100549252","phase-1-a-study-to-evaluate-the-safetytolerability-pharmacokinetics-and-clinical-activity-of-mocertatug-rezetecan-for-injection-in-participants-with-advanced-solid-tumors-behold-1-100549252","NCT06431594","A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care.\n* PROC cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) high-grade serous\u002Fendometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.\n  4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance.\n  5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtansine if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\nParticipants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\n* Endometrial cancer cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) or recurrent endometrial cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if the regimen is locally available, unless there is a documented contradiction or intolerance\n  4. All epithelial histologies are permitted including carcinosarcoma.\n* Participants have at least one target lesion as assessed per the RECIST 1.1\n* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Have received any B7-H4-targeted therapy\n* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.\n* Presence of pleural\u002Fabdominal effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion\n* Major surgery within 28 days prior to the first dose of study treatment.\n* Evidence of brain metastasis unless asymptomatic;\n* Has inadequate bone marrow reserve or hepatic\u002Frenal functions .\n* Mean Fridericia-corrected QT interval (QTcF) QTcF \\>450 msec or QTcF \\>480 msec for participants with bundle branch blocK;\n* Evidence of current clinically significant arrhythmias or ECG abnormalities\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events\n* Has current active pneumonitis\u002FILD or any history of ILD, any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization\u002Fenrollment or any history of drug-induced pneumonitis\u002FILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)\n* PROC\n\n  1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted.\n  2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.\n* Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.",{"count":143,"type":21},675,[24],"The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount",[97,28],[97,148,149,150,151],"Mocertatug rezetecan","Mo-Rez","GSK5733584","BEHOLD-1","2026-06-23",{"date":154,"type":33},"2026-06-25",{"date":156,"type":33},"2024-07-02",{"date":158,"type":21},"2029-12-31",{"name":160,"class":40},"GlaxoSmithKline",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":17,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":4,"leadSponsor":187,"locationsCount":72},"100063184","collection-of-tissue-specimens-from-patients-with-solid-tumors-or-blood-disorders-and-their-hla-compatible-family-members-100063184","NCT00071045","Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members","Collection of Blood, Bone Marrow, Urine, and\u002For Tissue Samples From Patients With Solid Tumors, Hematological Malignancies or Non-Malignant Hematologic Disorders or HLA Compatible Family Members","* INCLUSION CRITERIA:\n\nThe subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is being screened at the NIH for eligibility for an NIH protocol.\n\nOR\n\nThe subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is already enrolled on a protocol at the NIH Clinical Center.\n\nOR\n\nThe subject is a related HLA-compatible family member of a patient (bearing a diagnosis of malignant solid tumor or a malignant or non-malignant hematologic) being evaluated for or already enrolled on a protocol at the NIH Clinical Center and is identified as a potentially suitable donor of allogeneic hematopoietic stem cells for transplantation.\n\nOR\n\nThe subject carries the diagnosis of malignant solid tumor or a malignant or non malignant hematologic disorder or a bone marrow failure condition and is not available to participate in an NIH Clinical Center treatment protocol, or travel to the NIH clinical center, but is referred for participation through their home health care provider.\n\nThe subject or the subject's Legally Authorized Representative (LAR) is able to understand the investigational nature of the study and provide informed consent after initial counseling by an AI. Separate consent forms for interventional or surgical procedures will be obtained after explanation of the specific procedure.\n\nAge 2 years and older (no upper limit)\n\nEXCLUSION CRITERIA:\n\nSubjects or LAR unable to comprehend the investigational nature of the protocol.\n\nAge less than 2 years",true,"2 Years","100 Years",{"count":172,"type":21},6000,"OBSERVATIONAL","This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases. The specimens may be used to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, and explore opportunities for disease prevention.\n\nThe following individuals 2 years of age or older may be eligible for this study:\n\n* Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center\n* HLA-compatible donor family members (18 years of age or older) of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor\n* Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider.\n\nResearch samples will be collected from participants when blood is drawn or bone marrow, urine, or stool is collected, or tumor or other tissue is biopsied as part of their general medical care. Investigators may periodically request an additional sample of blood, stool, or urine. Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis. This procedure is not part of general medical care and would be done for research purposes only. For apheresis, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, where the white cells are separated from the red cells, platelets, and plasma by a spinning process. The white cells are removed and collected, and the rest of the blood is returned to the subject through a second tube placed in the other arm.\n\n...",[28,176,177],"Hematologic Neoplasms","Healthy Volunteers",[179,180,181,182],"Tissue Procurement","Sample Collection","Laboratory Research Specimens","Natural History",{"date":184,"type":33},"2026-06-24",{"date":186,"type":33},"2003-10-08",{"name":188,"class":71},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":168,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":207,"locationsCount":209},"100612842","phase-1-a-study-of-18fly4214835-in-healthy-volunteers-and-participants-with-cancer-100612842","NCT07258836","A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","A Phase 1, Open-Label Study to Evaluate the Safety, Biodistribution, Imaging Characteristics, and Radiation Dosimetry of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer","Inclusion Criteria:\n\n* Cohort 1\n\n  * Have a radiologically, cytologically, or histologically confirmed diagnosis of cancer\n  * Are treatment-naïve to a systemic cancer therapy, OR have a documented disease progression on standard-of-care treatment (for example, failure of chemotherapy, targeted therapy or immunotherapy)\n  * Have at least 1 imageable tumor that is 15 millimeter (mm) or larger in the longest diameter\n* Cohort 2\n\n  * Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* Are pregnant or intend to become pregnant during their participation in the study\n* Are breastfeeding or intending to breastfeed during their participation in the study\n* Have a history of risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome)\n* Are actively receiving cancer therapy or are in between cycles of treatment\n* Have a marked baseline prolongation of QT\u002Fcorrected QT interval (QTc) interval (for example, repeated demonstration of a QTc interval greater than (\\>) 450 millisecond (ms)",{"count":197,"type":21},41,[24],"The purpose of the study is to check how safe and well-tolerated \\[18F\\]LY4214835 injection is in healthy participants and participants with cancer. The study drug will be administered intravenously (IV) (into a vein). Participation in the study will last approximately 35 days.",[28,201],"Healthy","2026-06-22",{"date":152,"type":33},{"date":205,"type":33},"2025-12-22",{"date":131,"type":21},{"name":208,"class":40},"Eli Lilly and Company",6,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":72},"100644182","analysis-of-efficacy-and-outcomes-of-immunotherapy-for-malignant-tumors-a-prospective-non-interventional-clinical-study-100644182","NCT07665697","Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically or cytologically confirmed malignant tumor;\n3. Planned to receive immune checkpoint inhibitor (e.g., PD-1\u002FPD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy\u002Ftargeted therapy\u002Fradiotherapy, etc.);\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n5. Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);\n6. Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.\n\nExclusion Criteria:\n\n1. Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);\n2. Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;\n3. Pregnant or breastfeeding women;\n4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).",{"count":217,"type":21},500,"The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.",[28,220,221],"Drug Therapy","Immune Checkpoint Inhibitors (ICIs)","2026-06-19",{"date":184,"type":33},{"date":127,"type":21},{"date":226,"type":21},"2029-06-15",{"name":228,"class":229},"Sichuan University","OTHER",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100606000","phase-2-a-study-to-evaluate-ly3537021-for-the-treatment-of-nausea-and-vomiting-caused-by-chemotherapy-in-adults-with-cancer-100606000","NCT07169851","A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer","A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease","Inclusion Criteria:\n\n* Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg\u002Fm²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Have symptomatic or untreated central nervous system (CNS) metastases.\n* Have an established diagnosis of uncontrolled diabetes mellitus.\n* Have a history of, or current evidence of, a clinically significant cardiac condition or QT\u002FQTcF-related conditions.\n* Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity\n* Signs, symptoms or history of thyroid tumors\n* Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy.\n* Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.",{"count":238,"type":21},204,[25],"The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.",[242,243,244,28],"Nausea","Vomiting","Drug-Related Side Effects and Adverse Reactions",[246,247,248,249,250],"Chemotherapy-Induced Nausea and Vomiting (CINV)","Anthracycline and cyclophosphamide (AC)","Glucose-dependent Insulinotropic Peptide (GIP)","Incretins","Cisplatin",{"date":152,"type":33},{"date":253,"type":33},"2025-11-28",{"date":255,"type":21},"2027-02",{"name":208,"class":40},67,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":168,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":4,"leadSponsor":281,"locationsCount":282},"100166719","clinical-and-genetic-studies-of-li-fraumeni-syndrome-100166719","NCT01443468","Clinical and Genetic Studies of Li-Fraumeni Syndrome","Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome","* INCLUSION CRITERIA:\n* On referral, persons of all ages will be considered for inclusion in the study\n\nbecause of either:\n\n* A family or personal medical history of neoplasia consistent with the diagnosis of LFS or LFL; or,\n* A personal history of a germline TP53 mutation; or,\n* A first- or second- degree relative of a TP53 mutation carrier, regardless of mutation status; or,\n* A personal history of three or more LFS-related primary cancers; or,\n* A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any age, regardless of family history\n\nPersonal and family medical history must be verified through questionnaires, interviews, review\n\nof medical records and\u002For review of pathology slides.\n\nThere are 72 families who have previously enrolled in the pilot study under protocol 78-C-0039.\n\nAs the eligibility criteria remain the same, these families will be eligible for this protocol and will be invited to sign the new consent.\n\n-Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nFor both the Field and Clinical Center Cohort, the PI will ensure that study investigators will\n\nidentify an appropriate LAR consistent with requirements of Policy 403 and will obtain consent\n\nfrom the LAR as outlined in the consent process before initiating research interventions.\n\n-Pregnant women\n\nIn order to study the lifetime rates of cancer development in all individuals with Li-Fraumeni\n\nsyndrome, we will need to evaluate what effect pregnancy may have on rate of cancer\n\ndevelopment both in affected individuals and unaffected family controls. Additionally, some\n\ncancers are known to have an increased risk of development in the context of pregnancy and\n\nlactation. Exclusion of pregnant women would preclude understanding of these cancer risks for\n\nan important subset of the population.\n\nPregnant women are eligible for enrollment on the data collection component of this study.\n\nPregnant women will be included in this study as several endpoints may be assessed during\n\npregnancy; counseling, education, and other minimal risk procedures (i.e. blood draw) may be\n\ndone. We will postpone full clinical evaluations at the Clinical Center of pregnant women until\n\nthe subject has recovered post-partum.\n\nAll screening studies, for women who are pregnant, or breastfeeding will be deferred while the\n\nwoman is pregnant or breastfeeding. Pregnancy testing will be performed for females of childbearing age prior to imaging studies, and the test results must be negative prior to the scan..\n\nThe risk to the fetus and pregnant woman would be no greater than minimal for procedures that\n\nare performed.\n\nEXCLUSION CRITERIA:\n\n* Referred individuals and families whose reported diagnoses cannot be verified\n* Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude the ability to participate in clinical research\n* Women who are pregnant will not be eligible for the cancer screening protocol until they recover post-partum. Women participating in the cancer screening protocol will discontinue this component if they become pregnant while on study. Once they recover post-partum, they can continue the cancer screening protocol.",{"count":266,"type":21},5000,"Background:\n\n\\- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and factors that may increase or decrease cancer risk in people with the syndrome.\n\nObjectives:\n\n* To learn more about the types of cancers that occur in individuals with LFS.\n* To study the role of the TP53 gene in the development of cancer.\n* To look for other possible genes that cause LFS\n* To study the effect of LFS diagnosis on families.\n* To determine if environmental factors or other genes can change a person s cancer risk associated with LFS.\n\nEligibility:\n\n* Individuals with a family or personal medical history of cancers consistent with LFS.\n* Individuals with a family or personal medical history of cancers that does not meet the diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the so-called Li-Fraumeni like syndrome)\n* Individuals with certain rare cancers\n* Individuals with a family or personal history of a TP53 gene mutation, with or without related cancer(s).\n\nDesign:\n\n* Participants will fill out a medical history questionnaire and a family history questionnaire.\n* Blood samples will be collected for DNA and for storage. Cheek cell samples may be collected if blood cannot be obtained for DNA. Participants can choose to have or not have cancer screening with blood tests, imaging studies, and other exams.\n* Participants will complete questionnaires about their worries about cancer, stress levels, and coping strategies. Diet and physical activity questionnaires will also be given. Other psychological tests may be given as needed.\n* Participants will be monitored for several years, with regular followup visits to the National Institutes of Health, if indicated. Any changes in health or cancer status will be recorded.",[269,28,270],"Li-Fraumeni Syndrome","Tp53 Mutations",[272,273,274,275,276],"Tp53","Cancer","Hereditary","Genetic Testing","Screening","2026-06-18",{"date":202,"type":33},{"date":280,"type":33},"2012-01-17",{"name":70,"class":71},2,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100609363","phase-1-a-study-to-investigate-the-safety-and-preliminary-efficacy-of-gsk5460025-alone-or-in-combination-with-other-anti-cancer-agents-in-participants-with-solid-tumors-100609363","NCT07213609","A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors","A Phase 1\u002F2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors","Inclusion Criteria:\n\n* Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor\n* Has a known dMMR\u002FMSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)\u002F Microsatellite Instability (MSI) status at the time of Pre-screening and MMR\u002FMSI status will be determined by central reference laboratory\n* Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample\n* Intends to receive GSK5460025 as next treatment\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Is expected to have a minimum of 3 months life expectancy\n* Has adequate organ function, as defined in the protocol\n\nPart 1 inclusion criteria:\n\n• Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options\n\nPart 2 inclusion criteria:\n\n* Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC)\n* Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy\n* Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator\n\nExclusion Criteria:\n\n* Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs)\n* Has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent.\n* Is unable to swallow and retain orally administered study treatment\n* Has untreated or progressed metastases in brain or CNS\n* Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease.\n* Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs\n* Has cirrhosis or current unstable liver or biliary disease\n* Has known hypersensitivity to any of the study interventions or any of their excipients",{"count":291,"type":21},47,[24,25],"Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.",[295,28],"Neoplasms, Colorectal",[297,298,299,300,301,302,303,304,305,306],"GSK5460025","Solid tumors","Colon cancer","Rectal cancer","Colorectal cancer","Endometrial cancer","Mismatch repair deficient","dMMR","microsatellite instability high","MSI-H","2026-06-17",{"date":277,"type":33},{"date":310,"type":33},"2025-10-20",{"date":312,"type":21},"2028-10-27",{"name":160,"class":40},19,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":334,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":72},"100584158","phase-1-anti-mesothelin-tnaivescm-hyp218-tnhyp218-car-t-cells-in-participants-with-mesothelin-expressing-solid-tumors-including-mesothelioma-100584158","NCT06885697","Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy.\n\n* Participant must have unresectable, locally advanced, or metastatic, or recurrent mesothelioma and other mesothelin expressing solid tumors. For participants with mesothelioma only those with epithelioid or biphasic histology (with \\>80% epithelioid component) will be eligible. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI.\n* Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type. There is no limit on the number of prior treatment regimens. Note: Given the aggressive nature of pancreatic cancer, otherwise eligible individuals with this cancer type can undergo leukapheresis before or while they are getting their frontline treatment as long as they meet all other inclusion criteria. However, TNhYP218 CAR T cells will only be administered after progression on first line standard of care therapy.\n* Participant must have at least 1 measurable lesion by RECIST version 1.1.\n* Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\nSystem: Laboratory Value\n\nHematological\n\n* Hemoglobi: \\>=9 g\u002FdL(a)\n* absolute neutrophil count: \\>=1,500\u002FmcL\n* platelets: \\>=100,000\u002FmcL\n\nHepatic\n\n* total bilirubin: \\\u003C=2.5 X institutional ULN OR direct bilirubin ULN for participants with total bilirubin levels \\>1.5 X ULN\n* AST and ALT \\\u003C= 2.5 X institutional ULN (\\\u003C= 5 X ULN for participants with liver metastases)\n\nRenal\n\n* Creatinine OR: \\\u003C=1.5 X ULN OR\n* Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 50 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\nCoagulation\n\n* International normalized ratio (INR) OR prothrombin time (PT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\n   * Normal cardiac ejection fraction (\\>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.\n   * Room air oxygen saturation of 90% or greater.\n   * Treatment-related toxicities from prior treatments must be resolved to \\\u003C= grade 2.\n   * Participants with CNS metastases, leptomeningeal disease or carcinomatous meningitis are eligible if they are asymptomatic, have completed their treatment for CNS disease and have recovered from the acute effects of radiation therapy or surgery prior to study entry. Participants must have radiographically stable CNS disease without associated edema at least three months prior to study entry. Additionally, participants have had to have discontinued corticosteroid treatment or non-prophylactic antiseizure medications for these metastases at least four weeks prior to study entry.\n   * Participants of child-bearing potential and participants who can father children must agree to use highly effective contraception or abstinence.\n   * Participants who are nursing or plan to nurse a child must agree to discontinue\u002Fpostpone nursing for the duration of study therapy and for 12 months after the administration of the cell product or for 4 months from the time no evidence of persistence\u002Fgene modified cells is documented in the participant s blood.\n   * Ability of participant to understand and the willingness to sign a written informed consent document.\n\n   EXCLUSION CRITERIA:\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   * Prior systemic therapy, an investigational therapy, radiation, and\u002For surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.\n   * Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n   * Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n   * Participants with active or history of autoimmune or immune mediated disease such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. NOTE: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n   * History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n   * Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg\u002Fday of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed.\n   * Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders.\n   * Participant has any other prior or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 12 months prior to initiation of study therapy.\n     * Treated non-melanoma skin cancer.\n     * Stage 0 or 1 melanoma completely resected at least 12 months prior to initiation of study therapy.\n     * Successfully treated organ-confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.\n     * A primary malignancy which has been completely resected and in complete remission for \\>= 5 years.\n   * Electrocardiogram showing a QTc interval \\> 450 msec in males and \\> 470 msec in females (\\> 80 msec for participants with bundle branch block). Either Fridericia s or Bazett s formula may be used to correct the QT interval.\n   * Participant has active infection with HIV, hepatitis B virus, HCV, or HTLV as defined below:\n\n     * Positive serology for HIV, HTLV-1, or HTLV-2.\n     * Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.\n     * Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any reverse transcription PCR or branched DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.\n   * Participant is pregnant or intends to be pregnant during the required period of contraception for participants of childbearing potential.\n   * Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of treatment initiation\n   * Participants with a history of seizure disorder unless due to now treated metastatic lesions.\n   * Ongoing uncontrolled intercurrent illness, including but not limited to ongoing or active infection, that would impact participant safety or limit compliance with study requirements.",{"count":323,"type":21},100,[24],"Background:\n\nMesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.\n\nObjective:\n\nTo test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.\n\nEligibility:\n\nPeople aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.\n\nDesign:\n\nParticipants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nParticipant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.\n\nParticipants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.\n\nTNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.\n\nAfter discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.\n\nLong-term follow-up will continue another 10 years....",[327,28,328,329,330,331,332,333],"Mesothelioma","Stomach Neoplasms","Pancreatic Neoplasms","Ovarian Neoplasms","Lung Neoplasms","Thymus Neoplasms","Colonic Neoplasms",[335,336,337,338,339,340,341,342,343,344],"Peritoneal Mesothelioma","Thymic Carcinoma","Colon Cancer","Gastric Cancer","Lung Cancer","Ovarian Cancer","Pancreatic Cancer","mesothelin expressing solid tumors","CAR T cell therapy","Gene Therapy","2026-06-16",{"date":307,"type":33},{"date":348,"type":33},"2025-07-08",{"date":350,"type":21},"2044-06-01",{"name":70,"class":71},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":4},"100641305","early-phase-1-inhaled-mrna-immunotherapy-for-patients-with-advanced-lung-cancer-or-pulmonary-metastatic-solid-tumors-100641305","NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.",{"count":361,"type":21},60,[363],"EARLY_PHASE1","This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.",[28,97,366],"Neoplasm Metastasis","2026-06-14",{"date":277,"type":33},{"date":370,"type":21},"2026-06-10",{"date":372,"type":21},"2029-12",{"name":374,"class":229},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":168,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":385,"conditions":386,"keywords":405,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":72},"100641995","human-observatory-study-100641995","NCT07646782","Human Observatory Study","The Human Observatory: A Prospective Individual and Population-Level Study of Aging, Health, and Longevity","HOS","Inclusion Criteria:\n\n* Enrolled in the 100-Year Human Aging Study at any fixed or mobile clinical site; OR completion of online health screener with provision of geographic anchor data and consent.\n\nExclusion Criteria:\n\n* Age under 18 years (current protocol; pediatric amendment planned).",{"count":384,"type":21},1000000,"The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level. Individual multi-system clinical data from enrolled participants are linked to a continuously-ingested ecological data infrastructure spanning environmental exposures, social determinants, genealogical and family history records, mortality data, and population health databases at geographic resolutions from home address to global scale and beyond. The resulting model generates individual screening recommendations informed by population-level causal estimates, and population-level causal forecasts anchored by present-timepoint individual clinical biology. Thus creating a feedback architecture designed to improve both simultaneously.",[387,388,389,390,391,28,392,393,394,395,396,397,398,399,400,401,402,403,404],"Aging","Mortality","All-cause Mortality","Life Expectancy","Cardiovascular Diseases","Cognitive Dysfunction","Metabolic Syndrome","Frailty","Musculoskeletal Disease","Neurodegenerative Disease","Dementia","Activities of Daily Living","Health Related Quality of Life","Disability Physical","Environmental Exposure","Occupational Diseases","Health Equity","Social Determinants of Health",[406,407,408,409,410,411,412,413,414,415,416,417,418,403,419,420,421,422,423,424,425,426,427,428,429],"longevity","biological aging","causal inference","life expectancy","exposome","Environmental Health","Social Determinants","Genealogy","Family History","Human Family Tree","Population Health","Neighborhood Health","Geographic Health Disparities","Mortality Prediction","Biomarker Validation","Cardiopulmonary Exercise Testing","Body Composition","Preventive Medicine","Healthspan","Functional Decline","Centenarian","Space Medicine","Aerospace Medicine","World Model","2026-06-09",{"date":432,"type":33},"2026-06-15",{"date":434,"type":33},"2026-04-25",{"date":436,"type":21},"2099-12-31",{"name":438,"class":40},"Longevity Metrics, Inc.",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":168,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":447,"conditions":448,"keywords":454,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":72},"100636291","100-year-human-aging-study-100636291","NCT07563777","100-Year Human Aging Study","100-Year Human Aging Study: Prospective Longitudinal Validation of Multi-System Health Measurements Against Mortality and Aging Outcomes","Inclusion Criteria:\n\n* Age 18 years or older\n* Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative\n* Willing to participate in longitudinal follow-up\n\nExclusion Criteria:\n\n* Age under 18 years",{"count":384,"type":21},"The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed and mobile clinical sites to undergo comprehensive multi-system health screening and longitudinal follow-up until death. Participants are followed to determine whether measurements taken at enrollment and repeated across the lifespan - individually and in combination - predict all-cause mortality, cause-specific mortality, incident serious disease, and functional disability. The study is designed to generate the surrogate endpoint validation data that longevity medicine currently lacks.",[387,449,450,388,393,391,392,451,28,394,398,452,400,453,397],"Aging Well","All-Cause Mortality","Musculoskeletal Diseases","Health-Related Quality of Life","Neuro-Degenerative Disease",[455,421,422,423,456,419,425,424,390,457,458,459,420,460,416,426],"Longevity","Surrogate Endpoint Validation","Biological Aging","Preventive Screening","Longitudinal Cohort","Human Performance",{"date":462,"type":33},"2026-06-11",{"date":464,"type":33},"2025-02-09",{"date":436,"type":21},{"name":438,"class":40},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":282},"100633319","phase-1-a-study-of-jnj-1761981-in-participants-with-solid-tumors-100633319","NCT07525141","A Study of JNJ-1761981 in Participants With Solid Tumors","Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors","Inclusion criteria:\n\n* Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \\[CNS\\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines\n* Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \\[NCCN\\] guidelines) and whose disease has progressed after standard therapy\n* Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1\n* Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy\n* A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later\n\nExclusion criteria:\n\n* Active symptomatic disease involvement of the central nervous system\n* Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)\n* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients\n* Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection",{"count":475,"type":21},66,[24],"The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.",[28],"2026-06-04",{"date":481,"type":33},"2026-06-05",{"date":483,"type":33},"2026-05-26",{"date":485,"type":21},"2029-01-31",{"name":487,"class":40},"Johnson & Johnson Enterprise Innovation Inc.",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":506},"100540033","phase-1-a-study-of-jnj-87704916-as-monotherapy-and-in-combination-for-advanced-solid-tumors-100540033","NCT06311578","A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors","Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors","Inclusion Criteria:\n\n* For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC\n* Have at least 1 injectable tumor\n* Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1\n* A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study\n* Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy\n\nExclusion Criteria:\n\n* Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed\n* Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy\n* Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents\n* History of solid organ or hematologic stem cell transplantation\n* Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome\n* History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)",{"count":496,"type":21},126,[24],"The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.",[28],{"date":481,"type":33},{"date":502,"type":33},"2024-04-10",{"date":504,"type":21},"2032-08-26",{"name":487,"class":40},10,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":209},"100529810","phase-1-a-study-of-jnj-87890387-for-advanced-solid-tumors-100529810","NCT06178614","A Study of JNJ-87890387 for Advanced Solid Tumors","A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase\u002FPhosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma\n* Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (\\>) 2\\*upper limit of normal (ULN) during screening\n* All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening\n* Be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\n* Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for \\> 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \\[\\\u003C=\\]10 milligrams \\[mg\\] prednisone or equivalent) for at least 2 weeks prior to start of study treatment\n* Toxicity from prior anticancer therapy that has not resolved to Grade \\\u003C=1 (except alopecia, vitiligo, Grade \\\u003C=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)\n* History of Grade greater than or equal to (\\>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.\n* History of solid organ or hematologic stem cell transplantation\n* Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment",{"count":515,"type":21},200,[24],"The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).",[28,123],{"date":481,"type":33},{"date":521,"type":33},"2023-12-14",{"date":523,"type":21},"2029-02-07",{"name":525,"class":40},"Janssen Research & Development, LLC",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":544},"100527622","phase-1-a-study-of-jnj-88549968-for-the-treatment-of-calreticulin-calr-mutated-myeloproliferative-neoplasms-100527622","NCT06150157","A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms","A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Be greater than or equal to (\\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent\n* Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)\n* Participants with ET and MF with risk characteristics as described in the protocol\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\\\u003C=) 2\n* For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment\n* Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (\\>=) 3 years after treatment ended are allowed to enter the study\n* Prior solid organ transplantation\n* Either of the following regarding hematopoietic stem cell transplantation:\n\n  1. Prior treatment with allogenic stem cell transplant less than or equal to (\\\u003C=) 6 months before the first dose of JNJ-88549968 or\n  2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy\n* History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment",{"count":534,"type":21},220,[24],"The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\\[s\\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.",[28],{"date":481,"type":33},{"date":540,"type":33},"2023-12-20",{"date":542,"type":21},"2028-05-12",{"name":525,"class":40},33,{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":72},"100553163","phase-2-take-the-reins-the-effects-of-nutrient-timing-on-cancer-related-fatigue-100553163","NCT06482515","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)","Inclusion criteria (Participants must…):\n\n* Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);\n* Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for \\>2 months and expected to stay on it until progression is okay);\n* Have a baseline level of fatigue, as determined by at least one of the following:\n\n  1. Reporting a score of 4 or higher in response to the question, \"What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?\"\n  2. In the habit of taking daytime naps,\n  3. Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,\n* Be able to speak and\u002For read and write in English or Spanish;\n* Be at least 18 years old; and\n* Be able to provide informed consent.\n\nExclusion criteria (participants must not…)\n\n* Be underweight, as defined as a body mass index \\\u003C18.5 kg\u002Fm2;\n* Already eat all their food within a window that is 10 h or shorter most (6\u002F7) days of the week;\n* Be employed in a job where they regularly work away from the home at night (e.g., night shift);\n* Have surgery planned during the study duration;\n* Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder);\n* Be taking insulin; or\n* Be on enteral or parenteral nutrition.",{"count":553,"type":21},96,[25],"Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.",[28,557,558,559,560,561],"Blood Cancer","Fatigue","Diet Habit","Survivorship","Fasting, Intermittent","2026-06-03",{"date":481,"type":33},{"date":565,"type":33},"2024-11-04",{"date":567,"type":21},"2028-08-31",{"name":569,"class":229},"University of Maryland, Baltimore",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":597},"100468924","phase-1-study-of-abemaciclib-and-elacestrant-in-participants-with-brain-metastasis-due-to-erher-2--breast-cancer-100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.",{"count":579,"type":21},73,[24,25],"This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[583,584,585,28,586,587,588,589],"Breast Neoplasms","Brain Neoplasms","Neoplasms by Site","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases",{"date":479,"type":33},{"date":592,"type":33},"2022-08-31",{"date":594,"type":21},"2026-12",{"name":596,"class":40},"Stemline Therapeutics, Inc.",86,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":614,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":622,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":506,"type":21},[25],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[28,97,608,609,610,329,611,612,613,330],"HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Colorectal Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms",[608,615,616],"Zanidatamab","Basket Study","2026-06-02",{"date":619,"type":33},"2026-06-08",{"date":432,"type":21},{"date":158,"type":21},{"name":623,"class":229},"Haihua Yuan",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":649},"100319210","phase-2-long-term-follow-up-protocol-for-participants-treated-with-gene-modified-t-cells-100319210","NCT03435796","Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells","Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells","Inclusion Criteria:\n\n* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.\n* Must understand and voluntarily sign an Informed Consent Form\u002FInformed Assent Form prior to any study-related assessments\u002Fprocedures being conducted.\n\nExclusion Criteria:\n\nNot Applicable\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":632,"type":21},1541,[25,634],"PHASE3","This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.\n\nParticipants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.",[28],[638,639,640],"Long-term follow up","Gene-Modified T Cells","CAR T Cell","2026-06-01",{"date":617,"type":33},{"date":644,"type":33},"2018-07-19",{"date":646,"type":21},"2036-11-30",{"name":648,"class":40},"Celgene",205,{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":657,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":659,"conditions":660,"keywords":664,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":672,"completionDateStruct":4,"leadSponsor":674,"locationsCount":675},"100125401","collection-of-tissue-samples-for-cancer-research-100125401","NCT00900198","Collection of Tissue Samples for Cancer Research","Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)","* INCLUSION CRITERIA - ADULT:\n* Patients 18 years of age and older who are being evaluated and\u002For treated for cancer at the NIH Clinical Center or at participating sites:\n\n  * Who have a newly diagnosed malignancy for which they have not yet received treatment, or\n  * Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\n\n    * radiographic evidence of tumor growth and\u002For new metastases, or\n    * CBC w\u002Fdifferential and\u002For flow cytometry, or\n    * documented evidence by the treating physician of signs\u002Fsymptoms of clinical disease progression, or\n  * Who are currently undergoing treatment and for whom disease response has not yet been assessed,\n\n    ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.\n  * Patients with ongoing partial response (PR) or stable disease (SD) are eligible.\n\n    * For solid tumor diagnoses, confirmation of viable malignancy and\u002For \\\u003C90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.\n    * For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final flow cytometry report.\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.\n\nAt the NIH Clinical Center ONLY:\n\n* At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and\u002For treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.\n* Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and\u002For treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and\u002For MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.\n\n  * Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.\n\nEXCLUSION CRITERIA:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as but not limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).\n* Patients with invasive fungal infections.\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.\n  * Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible.\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR).\n\nINCLUSION CRITERIA - PEDIATRIC:\n\n* Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.\n* Ability and willingness to assent to participation, utilizing an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission.\n\nAt the NIH Clinical Center ONLY\n\n-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.\n\nEXCLUSION CRITERIA - PEDIATRIC:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics should be completed at least 1 week (7 days) prior to collection\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.\n* Blood only collections from patients with partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.","2 Months",{"count":266,"type":21},"Background:\n\n-Patients who are being evaluated and\u002For treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.\n\nObjectives:\n\n* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.\n* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.\n\nEligibility:\n\n-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and\u002For treated for cancer at the NIH Clinical Center participating sites.\n\nDesign:\n\n* This is a multicenter tissue procurement protocol with NCI as the coordinating center.\n* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.\n* For pediatric patients: tumor biopsy\u002Fresection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.\n* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents\u002Fguardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.\n* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.\n* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.",[28,661,662,663],"Lymphomas","Multiple Myeloma","Myelodysplastic Syndrome",[665,666,667,668,669,182],"Tissue Collection","Biospecimen","Assay Development","Tissue Acquisition","Tissue Biopsies","2026-05-29",{"date":641,"type":33},{"date":673,"type":33},"2006-07-06",{"name":70,"class":71},17]