[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenoid-cystic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenoid-cystic-carcinoma":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,61,74,101,129,150,177,205,234,257,281,300,382,407,471,494,515,555,580,604],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[28,29,30,31,32,33,34,35,36,37,38,39],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[41,42,43,44,45,46,47],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":21},"2026-07-16",{"date":56,"type":21},"2037-10-01",{"name":58,"class":59},"National Cancer Institute (NCI)","NIH",1,{"id":62,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":26,"conditions":65,"keywords":66,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":60},"100643883",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39],[41,42,43,44,45,46,47],"2026-07-01",{"date":69,"type":52},"2026-07-02",{"date":71,"type":21},"2026-07-07",{"date":56,"type":21},{"name":58,"class":59},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":60},"100498795","phase-1-cb-103-with-either-lenvatinib-or-abemaciclib-in-patients-with-notch-acc-100498795","NCT05774899","CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC","A Phase 1\u002F2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)","Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:\n\nEligibility Criteria\n\n1. Participants must have histologically confirmed adenoid cystic carcinoma (ACC) with evidence of recurrent, metastatic or advanced, incurable disease arising from any primary site\n2. Activating mutation in the NOTCH signaling pathway\n3. In Cohort 1 only, prior multitargeted VEGFR TKI or systemic therapy is permitted.\n4. In Cohort 2 only, no prior multitargeted VEGFR TKI therapy is permitted, but prior systemic chemotherapy as part of definitive or curative intent management is permitted.\n\n   a. Any participant must obtain prior approval from insurance to reimburse for oral Lenvatinib, or off-label drug assistance to secure Lenvatinib for the duration of the study or agree to self-pay for oral Lenvatinib or obtain institutional commitment from the study site to provide Lenvatinib.\n5. Age 18 years or older\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n7. Patients able and willing to swallow oral capsules or tablet medications.\n8. At least one measurable lesion (RECIST v1.1)\n9. Participant must have organ and marrow function as defined below within 14 days prior to study registration (ULN=upper limit of normal per institution):\n\n   Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL Hemoglobin (Hgb) ≥9 g\u002FdL (patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion).\n\n   Platelet count ≥100 x 109\u002FL (without transfusion within the last 5 days) Serum creatinine ≤1.5x ULN or serum creatinine clearance (CrCl) ≥50 mL\u002Fmin (estimated by Cockcroft-Gault formula) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3x ULN Total serum bilirubin ≤1.5x ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted).\n10. Baseline proteinuria with a urinalysis or urine dipstick value of 2+ requires a spot urine protein\u002Fcreatinine ratio of \\\u003C0.3 (or 24-hour urine collection protein value \\\u003C300 mg\u002Fg) in Cohort 2 only\n11. Participants with treated brain or CNS metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no convincing evidence of progression and patients are neurologically stable with no new neurological deficits.\n12. Female subjects of childbearing potential should have a negative serum pregnancy test within 7 days before start of study treatment.\n13. Female and male subjects of childbearing potential must agree to use an adequate method of contraception to avoid pregnancy (with at least 99% certainty) from screening through 90-days or 3-months post-treatment completion (see Appendix B).\n14. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n15. Patients who received chemotherapy must have recovered (CTCAE grade ≤1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy. A washout period of at least 21 days is required between last chemotherapy dose and start of therapy (provided the patient did not receive radiotherapy).\n\nExclusion Criteria\n\n1. Participant has untreated or clinically symptomatic CNS metastases and\u002For carcinomatous meningitis\n2. The patient has had major surgery within 14 days prior to study registration.\n3. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).\n4. Impairment of GI function or presence of GI disease that may significantly alter the absorption of the study agents (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n5. The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n6. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n7. Pregnant or lactating women. Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.\n8. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and start of therapy. Patients on anticoagulants that require INR monitoring (such as warfarin). The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study.\n9. Corrected QTcF \\>450 msec for males and \\>470 msec for females in screening",{"count":82,"type":21},32,[24,25],"The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes.\n\nThe names of the study drugs involved in this study are:\n\n* CB-103 (an oral NOTCH pathway inhibitor)\n* Abemaciclib (CDK4\u002F6 inhibitor)\n* Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))",[37,86,87],"Metastatic Adenoid Cystic Carcinoma","Recurrent Adenoid Cystic Carcinoma",[37,86,87,89],"ACC","RECRUITING","2026-06-25",{"date":93,"type":52},"2026-06-29",{"date":95,"type":52},"2023-06-01",{"date":97,"type":21},"2028-06-01",{"name":99,"class":100},"Glenn J. Hanna","OTHER",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100468301","phase-1-a-study-of-emiltatug-ledadotin-emi-le-in-participants-with-solid-tumors-100468301","NCT05377996","A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","A Phase 1\u002F2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","Inclusion Criteria:\n\n* Recurrent or advanced solid tumor and has disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.\n* Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1\n* Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:\n\n  1. All participants with TNBC\n  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.\n\nExclusion Criteria:\n\n* Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.\n* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.\n* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.\n* Prior B7-H4 targeted treatment.\n* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.\n* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.\n* Clinically significant cardiovascular disease\n* Active keratitis (inflammation of the cornea of the eye)",{"count":109,"type":21},360,[24,25],"A Study of Emi-Le in Participants with Solid Tumors",[113,114,115,116,117,118,37],"Triple Negative Breast Cancer","Breast Cancer","Endometrial Cancer","Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cavity Cancer","2026-06-24",{"date":93,"type":52},{"date":122,"type":52},"2022-08-15",{"date":124,"type":21},"2027-12",{"name":126,"class":127},"Day One Biopharmaceuticals, Inc.","INDUSTRY",26,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100525157","phase-1-study-of-rem-422-in-patients-with-recurrent-metastatic-or-unresectable-adenoid-cystic-carcinoma-100525157","NCT06118086","Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma","A Phase 1\u002F2, Multicenter, Open-label Study of REM-422, a MYB mRNA Degrader, in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma","Inclusion Criteria:\n\n1. Be able to provide informed consent.\n2. Be 18 years or older at the time of informed consent.\n3. Disease criteria:\n\n   1. Histologically confirmed ACC, any site of origin.\n   2. Dose Escalation phase ONLY:\n\n      * Have locally advanced or metastatic ACC\n      * Evidence of radiographic progression and\u002For signs and symptoms associated with their disease (eg, pain, dyspnea, reduced performance status). Participants who have stable disease while being treated with another agent that is not tolerated are eligible after the appropriate washout period.\n   3. Confirmatory Cohort phase ONLY:\n\n      * Have metastatic, recurrent, or unresectable ACC\n      * Measurable disease at the time of enrollment. At least 1 measurable lesion according to RECIST v1.1 criteria. Participants must have radiographic evidence of disease progression by RECIST v1.1 criteria ≤ 6 months prior to study enrollment. Radiographic eligibility as determined by Central IUO assay.\n      * MYB poison exon biomarker positive tumor(s) confirmed by central IUO assay.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Tumor Tissue Requirements\n\n   1. Dose Escalation Phase ONLY: be able to provide during Screening a tissue specimen of either a fresh biopsy of a non-target lesion or an archival tumor sample obtained within the last 6 years. A formalin-fixed paraffin-embedded (FFPE) block can be submitted or a minimum of 15 freshly sectioned unstained slides. Agree to an on-treatment biopsy to be obtained \\~4-8 weeks after initiation of REM-422 unless medically contraindicated.\n   2. Confirmatory Cohort phase ONLY: be able to provide, during Pre-Screening, a tissue specimen of either a fresh biopsy of non-targetable lesion or an archival tumor sample obtained within the last 6 years that is interpretable for the biomarker positivity. An FFPE block can be submitted or a minimum of 15 fresh sectioned unstained slides.\n6. At least 3 weeks since prior systemic non-investigational therapy at the time of start of REM- 422.\n7. Toxicities from prior therapy must be stable or recovered to ≤ Grade 1. Note: Stable chronic and clinically non-significant conditions (≤ Grade 2) that are not expected to resolve are exceptions (eg, neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies, etc.), and patients with these conditions may enroll.\n8. Participants must be able to swallow and retain oral medications.\n9. Oxygen saturation \\> 92% on room air or up to 2 L\u002Fmin supplemental oxygen by nasal cannula with ≤ Grade 1 dyspnea.\n10. Participants of childbearing potential (POCBP) must have a negative serum beta-human chorionic gonadotropin test result.\n11. Participants Of Child Bearing Potential must agree to use acceptable, effective methods of contraception as outlined in Appendix 1 and not donate ova from Screening until 6 months after discontinuation of REM- 422. Women who have undergone surgical or ablative sterilization or who have been postmenopausal for ≥ 2 years are not considered to be of childbearing potential.\n12. Men must agree to use acceptable, effective methods of contraception and must agree not to donate sperm from the start of receiving REM-422 until 6 months after discontinuation of REM-422.\n13. Adequate bone marrow, organ function and laboratory parameters\n\nExclusion Criteria:\n\n1. Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.\n2. Clinically significant active infection. Simple urinary tract infection, uncomplicated bacterial pharyngitis responding to active treatment are permitted. Participants receiving intravenous antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals or antifungals are permitted).\n3. Evidence of active HIV infection.\n4. Evidence of currently active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n5. Primary immunodeficiency.\n6. Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent. Topical or inhaled corticosteroids with minimal systemic absorption may enroll and continue minimal corticosteroids if the participant is on a stable dose.\n7. Live vaccine ≤ 6 weeks prior to the start of REM-422.\n8. Use of strong CYP3A inhibitors or CYP3A inducers\n9. Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (e.g., omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration or during the study\n10. Pregnancy or participants planning to become pregnant during the duration of the study, or lactation.\n11. Participants with malabsorption syndrome, a disease significantly affecting gastrointestinal function, or resection of the stomach or bowel.\n12. Current use of prohibited medication ≤ 1 week before starting REM-422.\n13. Clinically significant cardiovascular disease:\n14. Participants who have undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, meninges, or surgical procedures requiring general anesthesia) \\\u003C 4 weeks prior to enrollment.\n15. History of organ transplant that requires use of immunosuppressive agents.\n16. History or current autoimmune disease (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus).\n17. Radiation therapy ≤ 7 days prior to the start of REM-422.\n18. Concurrent or previous other malignancy (other than adenoid cystic carcinoma, hematologic malignancies, or primary central nervous system \\[CNS\\] malignancies) ≤ 2 years of enrollment, except curatively treated malignancies including basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix.\n19. Participants receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment.\n20. Unwillingness or inability to follow protocol requirements.\n21. Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results.",{"count":137,"type":21},125,[24,25],"The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with advanced Adenoid Cystic Carcinoma (ACC)",[37,86,87],"2026-06-23",{"date":119,"type":52},{"date":144,"type":52},"2023-12-20",{"date":146,"type":21},"2027-09-30",{"name":148,"class":127},"Remix Therapeutics",9,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100642073","surgery-plus-postoperative-radiotherapy-for-t4-sinonasal-adenoid-cystic-carcinoma-a-prospective-observational-study-100642073","NCT07652489","Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma: A Prospective Observational Study","SPORT-SNACC: A Prospective, Multicenter, Observational Cohort Study of Surgery Plus Postoperative Radiotherapy in T4 Sinonasal Adenoid Cystic Carcinoma","SPORT-SNACC","Inclusion Criteria:\n\n1. Age 18 80 years, any gender; ECOG performance status 0 2; life expectancy ≥6 months.\n2. Histologically confirmed primary sinonasal adenoid cystic carcinoma (cribriform, tubular, solid, or mixed type). Other malignancies excluded.\n3. T4 stage (T4a or T4b) according to AJCC 8th edition, based on contrast enhanced MRI\u002FCT.\n4. N0 2 (operable lymph node metastasis allowed).\n5. M0 (no distant metastasis on chest CT and abdominal ultrasound) OR M1 with stable limited lung metastases; (c) stable on two CT scans ≥3 months apart; (d) no respiratory symptoms.\n6. Previously untreated (no radiotherapy, chemotherapy, targeted therapy, immunotherapy, or tumor resection). MDT deems technically resectable (R0\u002FR1 achievable, not diffusely unresectable).\n7. Adequate organ function within 14 days before enrollment: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, Hb ≥90 g\u002FL; ALT\u002FAST ≤2.5×ULN, TBil ≤1.5×ULN, Cr ≤1.5×ULN or CrCl ≥50 mL\u002Fmin; LVEF ≥50%, no uncontrolled arrhythmia.\n8. Willing and able to provide written informed consent for clinical data collection (and optional biospecimen banking). Investigator judges good compliance.\n\nExclusion Criteria:\n\n1. Progressive lung metastases within 6 months (new lesions or \\>20% increase); extrapulmonary metastases (liver, bone, brain); symptomatic lung metastases.\n2. MDT judged unresectable, e.g., bilateral cavernous sinus invasion, brain parenchyma invasion, bilateral internal carotid artery encasement.\n3. Primary tumor outside sinonasal cavity (e.g., major salivary glands, oropharynx); non ACC histology.\n4. Other active malignancy within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, etc.).\n5. Severe comorbidities: NYHA class III\u002FIV heart failure, recent myocardial infarction or unstable angina, uncontrolled hypertension (≥160\u002F100 mmHg); COPD requiring home oxygen or interstitial lung disease; decompensated cirrhosis; active hepatitis B\u002FC without antiviral therapy; nephropathy requiring dialysis; active serious infection; active bleeding or coagulopathy (INR \\>1.5×ULN without anticoagulation, or platelets \\\u003C50×10⁹\u002FL).\n6. Special populations: pregnant or breastfeeding; unwilling to use contraception (if childbearing potential); severe allergy to medications required for surgery\u002Fradiotherapy; severe psychiatric or cognitive disorder impairing cooperation; currently participating in another interventional trial.\n7. Unable to undergo contrast enhanced MRI (metal implants, claustrophobia, gadolinium allergy); investigator judges inability to complete follow up (e.g., living abroad, substance abuse).","80 Years",{"count":160,"type":21},70,"OBSERVATIONAL","This observational study follows patients with T4 stage sinonasal adenoid cystic carcinoma (a rare cancer of the nasal cavity\u002Fsinuses) who receive standard treatment: surgery followed by postoperative radiotherapy. The main goal is to measure the 3-year progression-free survival rate (the percentage of patients alive without cancer growth or spread). We will also assess overall survival, recurrence, side effects, and quality of life. This multicenter, prospective study will provide much-needed real-world data to improve patient counseling and guide future research.",[37,164],"Sinonasal Carcinoma",[166],"Carcinoma, Adenoid Cystic, Sinonasal, Radiotherapy, Adjuvant, Prospective Studies, Observational Study, Progression-Free Survival","2026-06-12",{"date":169,"type":52},"2026-06-17",{"date":171,"type":21},"2026-06-01",{"date":173,"type":21},"2031-06-01",{"name":175,"class":100},"Eye & ENT Hospital of Fudan University",6,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":203,"locationsCount":204},"100638733","phase-2-neoadjuvant-anlotinib-and-epirubicin-for-t4-sinonasal-adenoid-cystic-carcinoma-100638733","NCT07616141","Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma","Neoadjuvant Anlotinib Combined With Epirubicin for T4 Stage Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial","NAET4-SNACC","Inclusion Criteria:\n\n* Age 18 to 75 years, any sex.\n* Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype).\n* Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable.\n* Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; ALT\u002FAST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin; left ventricular ejection fraction (LVEF) ≥50%.\n* Willing to participate and able to provide written informed consent (including for clinical treatment and translational research).\n\nExclusion Criteria:\n\n* Prior radiotherapy to the head and neck region.\n* Prior anthracycline therapy with cumulative dose ≥300 mg\u002Fm².\n* Known hypersensitivity to any component of anlotinib or epirubicin.\n* Uncontrolled hypertension, severe cardiovascular disease, or active infection.\n* Pregnant or breastfeeding women.\n* Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.","75 Years",{"count":187,"type":21},76,[25],"T4 stage sinonasal adenoid cystic carcinoma (SNACC) is a rare but aggressive cancer in the nasal cavity and sinuses. These tumors often invade the skull base, eye socket, or brain covering (dura), making complete surgical removal difficult and carrying a high risk of recurrence even after surgery and radiation. The goal of this study is to test whether a new combination of drugs given before surgery - anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug) - can improve outcomes for patients with T4 SNACC.\n\nThis is a prospective, multicenter, single-arm, phase II clinical trial. Eligible participants will receive 2 cycles of neoadjuvant treatment (anlotinib orally for 2 weeks on\u002F1 week off, plus epirubicin intravenously on day 1 of each 3-week cycle). After completing neoadjuvant therapy, participants will undergo surgery to remove the tumor, followed by postoperative radiotherapy. The main question the study tries to answer is whether this approach increases the 3-year progression-free survival (PFS) rate compared to the historical rate of about 70% with standard treatment (surgery plus radiotherapy alone). Secondary questions include how many tumors shrink after neoadjuvant treatment, how many operations achieve complete removal with negative margins, major pathological response rates, overall survival, safety, quality of life, and the chance of avoiding disfiguring surgeries (such as removal of the eye or part of the skull). The study will enroll about 76 participants from 5 top medical centers in China. If positive, this study may establish a new standard of care for T4 SNACC.",[37],[37,192,193,194,195,196,197,198],"Sinonasal","T4 Stage","Neoadjuvant Therapy","Anlotinib","Epirubicin","Prospective Study","Phase II Clinical Trial","2026-05-23",{"date":171,"type":52},{"date":171,"type":21},{"date":173,"type":21},{"name":175,"class":100},5,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":213,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":60},"100636238","spare-1st-surgery-alone-vs-surgery-plus-postoperative-radiotherapy-for-sinonasal-adenoid-cystic-carcinoma-100636238","NCT07563088","SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma","Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study","SPARE-1st","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Histologically confirmed adenoid cystic carcinoma of cribriform or tubular type (solid type excluded) by central pathology review.\n* Completed radical surgical resection with postoperative pathology confirming R0 resection (negative microscopic margins).\n* Tumor stage T1, T2, or T3 according to AJCC 8th edition, with N0 and M0 status.\n* Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region).\n* ECOG performance status 0 or 1.\n* Adequate bone marrow, liver, and kidney function within 14 days before enrollment:\n\n  * Absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN.\n  * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Tumor stage T4, or presence of regional lymph node metastasis (N+), or distant metastasis (M1).\n* Postoperative pathology showing positive margins (R1 or R2).\n* Prior head and neck radiotherapy.\n* Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Uncontrolled serious concomitant disease (e.g., unstable angina, recent myocardial infarction, uncontrolled hypertension).\n* Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.\n* Psychological, social, or geographic factors that may interfere with study compliance.",{"count":214,"type":21},200,"Background:\n\nSinonasal adenoid cystic carcinoma (ACC) is a rare type of cancer that starts in the nasal cavity or sinuses. Although surgery can remove the tumor, doctors often recommend radiation therapy after surgery to reduce the chance of the cancer coming back. However, radiation can cause long-term side effects such as bone damage, dry mouth, or difficulty opening the mouth. For patients whose tumor has been completely removed (called R0 resection) and who have early-stage disease (T1-T3) without spread to lymph nodes or other organs, it is not clear whether routine radiation therapy is always needed.\n\nStudy Objective:\n\nThis study aims to find out whether simply watching and waiting (surgery alone) is not worse than adding radiation therapy (surgery plus radiation) in terms of keeping patients free from cancer for at least 3 years. If surgery alone is shown to be as good as surgery plus radiation, some patients may be able to avoid the side effects of radiation.\n\nStudy Design:\n\nThis is a prospective, multicenter, real-world study. It is not a randomized trial - patients and their doctors will decide together whether to have radiation after surgery. We will follow about 200 patients from many hospitals across China. About half will receive surgery alone, and the other half will receive surgery followed by radiation therapy. All patients will be followed for at least 3 years.\n\nHypothesis:\n\nWe hypothesize that surgery alone is not inferior to surgery plus radiation therapy for 3-year disease-free survival, with a non-inferiority margin of a hazard ratio of 1.35. In other words, even if surgery alone has a slightly higher risk of cancer returning, the difference is small enough that avoiding radiation side effects may still be worthwhile.\n\nMain Outcome:\n\nThe main outcome is the percentage of patients who are alive and free from cancer recurrence (local, regional, or distant) or death from any cause at 3 years after treatment.\n\nPotential Impact:\n\nIf our hypothesis is confirmed, this study could change current practice. Many patients with completely resected, early-stage sinonasal ACC might safely avoid postoperative radiation and its long-term side effects, improving their quality of life without compromising cancer control.",[37,164],[218,219,220,221,222,223,224,225],"Sinonasal Adenoid Cystic Carcinoma","Radiotherapy","Adjuvant","Watchful Waiting","Observational Study","Prospective Studies","Non-Inferiority Trials","Disease-Free Survival","2026-05-08",{"date":228,"type":52},"2026-05-12",{"date":230,"type":21},"2026-05-01",{"date":232,"type":21},"2032-05-01",{"name":175,"class":100},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":256,"locationsCount":60},"100633145","phase-2-a-study-of-becotatug-vedotin-mrg003-combined-with-epirubicin-as-neoadjuvant-therapy-for-egfr-positive-unresectable-recurrent-sinonasal-adenoid-cystic-carcinoma-100633145","NCT07522879","A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma","Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study","MRG003-SACC","Inclusion Criteria:\n\nAge ≥ 18 years, male or female. Histopathologically confirmed primary sinonasal adenoid cystic carcinoma (SNACC) that is locally recurrent after prior surgery and\u002For radiotherapy.\n\nEGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.\n\nMultidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.\n\nAt least one measurable lesion in the skull base\u002Fsinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.\n\nWilling to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.\n\nExclusion Criteria:\n\nPrior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.\n\nPrior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.\n\nActive uncontrolled infection, or active autoimmune disease requiring systemic therapy.\n\nSymptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.\n\nKnown severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men\u002Fwomen planning to become pregnant within 6 months after the last dose of study treatment.\n\nAny medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.",{"count":243,"type":21},40,[25],"This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.",[37,164],[248,249,250,192,251,196,223],"EGFR protein","Unresectable","Adenoid cystic carcinoma","Becotatug vedotin",{"date":228,"type":52},{"date":230,"type":21},{"date":255,"type":21},"2030-07-01",{"name":175,"class":100},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":60},"100617583","phase-2-epirubicin-interventional-chemotherapy-for-sinonasal-adenoid-cystic-carcinoma-snacc-a-prospective-study-100617583","NCT07320508","Epirubicin Interventional Chemotherapy for Sinonasal Adenoid Cystic Carcinoma (SNACC): A Prospective Study","A Prospective, Multicenter Study of Transarterial Epirubicin Chemotherapy in the Treatment of Sinonasal Adenoid Cystic Carcinoma","EIC-SNACC","Inclusion Criteria:\n\n1. Age between 18 and 70 years.\n2. Histologically confirmed diagnosis of sinonasal adenoid cystic carcinoma (ACC).\n3. Tumor stage T3 or T4 according to the AJCC (American Joint Committee on Cancer) 8th edition staging system. Participants with lymph node metastasis must be amenable to surgical dissection. Those with distant metastasis must have stable disease.\n4. Ability to provide a sufficient volume (≥0.5 cm³) of fresh tumor tissue via biopsy or surgery for research purposes, with participant's informed consent.\n5. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 to 2.\n6. Voluntary participation and provision of written informed consent. Good compliance, able to cooperate with treatment and follow-up.\n\nExclusion Criteria:\n\n1. Prior treatment with Epirubicin or any other anthracycline-based chemotherapy.\n2. Prior radiotherapy to the head and neck region.\n3. Administration of any other chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to study enrollment.\n4. Concurrent participation in another interventional drug clinical trial.\n5. Inadequate liver, kidney, or bone marrow function that does not meet the requirements for the planned treatment regimen.\n6. Contraindications to anthracycline-containing chemotherapy regimens: known allergy to anthracyclines, presence of ≥ Grade 2 peripheral neuropathy, or uncontrolled nausea\u002Fvomiting or chronic gastrointestinal diseases.\n7. Severe uncontrolled acute infection or decompensated major organ dysfunction.\n8. Pregnancy or lactation.","70 Years",{"count":267,"type":21},100,[25],"This study is for patients with locally advanced sinonasal adenoid cystic carcinoma (SNACC), a rare and challenging cancer that tends to invade nerves and the skull base. The research aims to test a new precise treatment strategy. First, all participants will receive three sessions of \"interventional chemotherapy\" (transarterial chemoembolization) with the drug Epirubicin, which delivers high-dose chemotherapy directly to the tumor to shrink it as much as possible. About 4-6 weeks after the third session, doctors will use MRI scans to evaluate how well the tumor responded. Based on this response, patients will follow one of two personalized treatment paths: those whose tumors did not completely disappear will undergo surgery followed by radiotherapy; those whose tumors show complete disappearance on imaging will receive precise radiotherapy alone, potentially avoiding major surgery. This is a prospective, multicenter study. The main goals are to evaluate the safety and effectiveness of this response-adapted strategy and to see if it can improve outcomes for patients with this difficult-to-treat cancer.",[37,164,196],[272,273,274],"transarterial chemoembolization","objective response rate","2-year progression-free surviva",{"date":228,"type":52},{"date":277,"type":52},"2026-01-20",{"date":279,"type":21},"2029-12-12",{"name":175,"class":100},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":60},"100605435","phase-2-phase-ii-trial-of-puxitatug-samrotecan-azd8205-in-advanced-recurrent-or-metastatic-rm-aggressive-adenoid-cystic-carcinoma-subtype-i-acc-i-100605435","NCT07162480","Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R\u002FM) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)","Inclusion Criteria:\n\n1. Patients ≥18 years with histology-proven advanced, or R\u002FM ACC.\n2. Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent\u002Fmetastatic disease\n3. ACC-I subtype defined by at least one of the following:\n\n   1. Presence of an activating NOTCH mutation per in-house or any CLIA-certified or commercially available next-generation sequencing assay\n   2. Solid histology and clinical course characterized by \\\u003C 3 years from diagnosis to initial recurrence or progression or de novo metastatic disease with extra-pulmonary metastasis\n   3. Negative TP63 tumor expression by IHC (\\\u003C10% of tumor cells)\n4. Measurable disease per RECIST 1.1\n5. Performance status ECOG of 0 or 1\n6. Patient has provided informed consent.\n7. Adequate bone marrow, hepatic, and renal function with the most recent laboratory assessments 8. Contraceptive use by the participant or the participant's partner should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   (a) Male participants: (i) Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus spermicide, if available) from enrollment throughout the study and for 8 months following the last dose of study drug. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period, as described in Table 3. In addition, male participants must refrain from sperm donation while on study and for 8 months (5 half-lives plus 6 months) following the last dose of study drug.\n\n   (b) Female participants: (i) Females of childbearing potential must have a negative urine or serum pregnancy test prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n(ii) Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly, from enrollment throughout the study and for 8 months following the last dose of study drug. It is strongly recommended for the male partner of a female participant to also use male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician.\n\n9\\. Patients can be treatment-naïve or have received up to 3 lines of prior systemic therapy in the setting ofR\u002FM disease, however, a maximum of two prior lines of chemotherapy or antibody-drug conjugate (ADC) are allowed. Exceptions include prior B7-H4-targeting ADC or any prior agent with a topoisomerase inhibitor\n\n1 mode of action; those represent exclusion criteria (exclusion criteria #18).\n\nExclusion Criteria:\n\n1. Treatment with any of the following as detailed below in Table 2:\n\n   Table 2 . Washout period from prior therapies Treatment Washout period Nitrosourea or mitomycin C Within 6 weeks prior to the first dose of study intervention Any investigational agents or study drugs from a previous clinical study Within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study drug Any other anticancer treatment Within the following time periods prior to the first dose of study intervention: Cytotoxic treatment: 21 days Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter) Biological products including immuno-oncology agents: 28 days Radiotherapy Wide field of radiation (including whole brain radiotherapy) within 4 weeks or limited field radiotherapy (including stereotactic radiotherapy or gamma-knife) for palliation is allowed up to 14 days prior to the first dose of study intervention. Participants who have not recovered from radiotherapy-related toxicity will not be eligible Major surgery (as defined by the Investigator) At least 28 days prior to the first dose of study intervention\n2. Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE version 5.0) from prior therapy (excluding vitiligo, alopecia, endocrine disorders that are controlled with replacement hormone therapy, and lymphopenia unless it is accompanied by clinical signs of infection or the indication for prophylaxis with antibiotic\u002Fantiviral\u002Fantifungal therapy). Participants with chemotherapy-induced Grade 2 neuropathy may be eligible at discretion of the Investigator.\n3. Active infection, including tuberculosis, SARS-CoV-2, and known infections with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency. Participants with a past or resolved HBV\u002FHCV infection are eligible if all the following criteria are met:\n\n   1. Negative for HBsAg and positive for total hepatitis B core antibody (anti-HBc) or Positive for HBsAg, but for \\> 6 months have had normal transaminases and HBV DNA levels between 0-2000 IU\u002FmL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study.\n   2. HBV DNA levels \\> 2000 IU\u002FmL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study.\n   3. Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.\n4. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior pneumonectomy (complete) or require supplemental oxygen (including intermittent or discretionary use).\n6. Patients with history of myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML (as determined by prior diagnostic investigation). Specific screening for MDS\u002FAML is not required.\n7. Participants with any of the following cardiac criteria:\n\n   1. History of clinically significant arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE version 5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.\n\n      NOTE: abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, magnesium) should be corrected before starting the study intervention\n   2. Uncontrolled hypertension.\n   3. Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of the start of study treatment.\n   4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n   5. Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).\n   6. Prior or current cardiomyopathy.\n   7. Severe valvular heart disease.\n   8. Resting corrected QT interval using Fridericia's formula (QTcF) \\> 470 msec\n   9. Any factors that increase the risk of corrected QT (interval) (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.\n   10. Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study intervention or during the scheduled ECG assessments (see \\\u003C\\\u003C https:\u002F\u002Fwww.crediblemeds.org\u002F \\>\\>).\n8. Active CNS disease (patients with asymptomatic or treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks prior to start of study treatment are not considered active)\n9. Uncontrolled intercurrent illness within the last 12 months of start of study treatment, including but not limited to serious chronic GI conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.\n10. Has substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.\n11. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note:\n\n    Participants, if enrolled, should not receive live attenuated vaccine whilst receiving study intervention and up to 30 days after the last dose of study intervention. Participants can receive COVID-19 vaccines, at the discretion of the Investigator, following a benefit\u002Frisk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines.\n\n    Note: If a COVID-19 vaccine is administered it should be done \\> 72 hours prior to study intervention initiation.\n12. For women only - currently pregnant (confirmed with positive pregnancy test), lactating, breastfeeding, or intend to become pregnant during the study.\n13. Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.\n14. Current participation in another interventional clinical study\n15. History of previous malignancy other than malignancy treated with curative intent and low risk of recurrence. Patients with the following diagnoses represents an exception and may enroll if ≥ 2 years with no evidence of active disease before the first dose of the study drug or if treatment is not indicated:\n\n    1. Non-melanoma skin cancers with no current evidence of disease\n    2. Melanoma in situ with no current evidence of disease\n    3. Treated or localized, low-risk, cancer of the prostate with prostate-specific antigen of \\\u003C1 ng\u002FmL\n    4. Treated or localized well-differentiated thyroid cancer (stage I)\n    5. Cervical carcinoma in situ\n    6. Treated ductal\u002Flobular carcinoma in situ of the breast\n    7. Treated or localized, low grade, renal cell carcinoma (stage I)\n16. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient\n17. Cognitively impaired patients who are incompetent to consent.\n18. Prior exposure to a B7-H4 targeting ADC, or any prior agent with a topoisomerase inhibitor 1 mode of action.",{"count":288,"type":21},28,[25],"Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R\u002FM ACC-I patients.",[37],{"date":293,"type":52},"2026-05-04",{"date":295,"type":52},"2026-04-29",{"date":297,"type":21},"2031-12-31",{"name":299,"class":100},"M.D. Anderson Cancer Center",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":352,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":288,"type":21},[25],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[312,313,314,315,316,317,318,319,320,321,322,323,37,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Mesothelioma","Neuroblastoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Osteosarcoma","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Soft Tissue Sarcoma","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[353,313,354,314,315,355,356,318,357,320,358,322,359,360,361,362,324,325,363,364,328,329,330,331,365,333,117,335,366,337,367,339,368,341,342,369,370,344,345,346,371,348,37,349,350,351],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":374,"type":52},"2026-04-15",{"date":376,"type":52},"2024-07-16",{"date":378,"type":21},"2028-05",{"name":380,"class":100},"Instituto do Cancer do Estado de São Paulo",8,{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"100584608","phase-2-a-study-of-enfortumab-vedotin-in-people-with-adenoid-cystic-carcinoma-100584608","NCT06891560","A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma","Phase II Trial of Enfortumab Vedotin in Recurrent and\u002For Metastatic Adenoid Cystic Carcinoma","Inclusion Criteria:\n\n* Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.\n* Patients must have recurrent and\u002For metastatic disease not amenable to other curative intent therapy.\n* At least 4 weeks must have elapsed since the end of prior systemic treatment and\u002For 2 weeks since completion of radiotherapy with resolution of all treatment related toxicity to NCI CTCAE Version 5.0 grade \\\u003C1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment.\n* Patients must have RECIST V1.1 measurable disease, defined as at least one nonnodal lesion measuring ≥ 20 mm with conventional techniques or as ≥10mm with CT scan, MRI, or calipers by clinical exam in the longest dimension AND\u002FOR a nodal lesion measuring ≥ 15 mm in the shortest dimension. Tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment.\n* Patients must have documentation of a new or progressive lesion on radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and\u002For new\u002Fworsening disease related symptoms within 6 months prior to study enrollment. Note: This assessment will be performed by the treating investigator and evidence of progression by RECIST criteria is not required.\n* Age ≥ 18 years of age on the day of signing informed consent.\n* ECOG performance status 0 or 1 (or Karnofsky ≥ 70%).\n* Patients must have tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable (paraffin block or at 30 unstained slides would be ideal). Patients without available tissue for submission may still be eligible if approved by the Principal Investigator. Additional tissue collection is not a requirement for this study.\n* Screening laboratory values must meet the following criteria:\n\n  * Neutrophils ≥ 1500\u002FμL\n  * Platelets ≥ 100x10\\^3\u002FμL\n  * Hemoglobin \\> 9.0 g\u002FdL (without packed red blood cell (pRBC) transfusion within the last 2 weeks)\n  * AST and ALT ≤ 2.5 x ULN (if liver metastases are present, AST and ALT ≤ 5x ULN)\n  * Total Bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5 x ULN (except participants with Gilbert Syndrome, who can have a total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * Serum creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 40 mL\u002Fmin per the Cockcroft-Gault formula if creatinine is \\>1.5 x ULN\n  * Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg\u002FdL\n  * Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg\u002FdL\n* Participants must be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial specific procedure.\n* Male participants must agree to use adequate contraception and refrain from donating sperm from start of therapy through 4 months after last dose of trial treatment.\n* Female participants must agree not to donate ova starting at screening and throughout the study period, and for at least 3 weeks after the final dose of study drug.\n* A female participant is eligible to participate if 1) she is not pregnant (for women of child-bearing potential, a pregnancy test must be negative within 72 hours prior to initiation; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required) OR 2) she is not a woman of child bearing potential as defined by one of the following criteria:\n\n  * Pre-menopausal with one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy\n  * Postmenopausal females defined as no menses for 12 months without an alternative medical cause. However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n* A woman of childbearing potential must use highly effective contraception from the start of therapy through 2 months after the last dose of study medication.\n\nExclusion Criteria:\n\n* Untreated brain metastasis (subjects with treated brain metastases will be eligible, provided that they are radiographically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\], clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment).\n* Prior malignancy if diagnosed and treated within 2 years of trial drug initiation. Patients may be included if they have completed therapy for a prior malignancy \\>2 years prior to drug initiation and are currently no evidence of disease (NED). Exception: Participants with non-melanoma skin cancer or carcinoma in situ (breast DCIS, or cervical CIS) that have undergone potentially curative therapy at any time are not excluded from trial participation.\n* Prior systemic anti-cancer therapy within 4 weeks of start of study treatment.\n* ≥ Grade 2 peripheral neuropathy per CTCAE v5.0 criteria.\n* Dry eyes, keratitis, keratopathy, and active conjunctivitis.\n* New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months (baseline echocardiogram is not required unless clinically indicated).\n* Active infection, defined as any infection requiring systemic treatment\n* Subject is known to be positive for Human Immunodeficiency Virus (HIV) or active Hepatitis C Virus (HCV) or active hepatitis B (HBV) infection (positive viral load). Testing for HIV, HCV, or HBV prior to initiation of the study drug is not required. If patient's have a known history of treated HCV, then a viral load is required to confirm clearance of infection.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Renal failure requiring active hemo- or peritoneal dialysis.\n* Breast feeding is not allowed from the start of treatment through 3 weeks after the last dose of study drug.\n* Has a history or current evidence of any medical or other condition, therapy or laboratory abnormality which, in the opinion of the investigator, might confound the results of the study, or preclude participation in a clinical study.",{"count":390,"type":21},34,[25],"The purpose of this study is to find out whether enfortumab vedotin is an effective and safe treatment for people with adenoid cystic carcinoma (ACC).",[37],[395,396],"Enfortumab Vedotin","24-215","2026-03-18",{"date":399,"type":52},"2026-03-20",{"date":401,"type":52},"2025-03-31",{"date":403,"type":21},"2027-03",{"name":405,"class":100},"Memorial Sloan Kettering Cancer Center",7,{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":158,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":441,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100328442","phase-1-vmd-928-monotherapy-and-in-combination-with-pembrolizumab-to-treat-trka-overexpression-driven-solid-tumors-or-lymphoma-100328442","NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.",{"count":415,"type":21},242,[24,25],"This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[419,37,420,421,422,324,423,424,29,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440],"Head and Neck Carcinoma","Lung Cancer","Non-Small Cell Lung Cancer","Pancreatic Cancer","Esophageal Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Head and Neck Squamous Cell Carcinoma HNSCC","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Head and Neck Cancers - Throat","Small Cell Lung Cancer ( SCLC )","Lung Cancer (Locally Advanced or Metastatic)","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[442,443,419,37,420,421,444,324,445,446,447,448,449,89,450,438,451,452,453,454,455,456,457,458,459,460],"TrkA","NTRK1","NSCLC","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","SCLC","HNSCC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea","2025-12-04",{"date":463,"type":52},"2025-12-11",{"date":465,"type":52},"2018-06-08",{"date":467,"type":21},"2028-06",{"name":469,"class":127},"VM Oncology, LLC",15,{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100551599","phase-1-study-of-safety-and-efficacy-of-rgt-61159-in-adults-with-relapsedrefractory-adenoid-cystic-carcinoma-acc-or-colorectal-carcinoma-crc-100551599","NCT06462183","Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed\u002FRefractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)","A Phase 1a\u002F1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed\u002FRefractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)","Inclusion Criteria:\n\n* Histologically confirmed ACC or CRC\n* Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation\n* Patients with locally relapsed\u002Frefractory (R\u002FR) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry\n* Patients with CRC must have locally R\u002FR advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.\n* Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Resolved acute effects of any prior therapy to baseline\n\nExclusion Criteria:\n\n* Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1\n* Chemotherapy within 14 days prior to Cycle 1 Day 1\n* Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1\n* Radiation therapy within 21 days prior to Cycle 1 Day 1\n* Investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1\n* Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment\n* Active known second malignancy\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2 unless it's well-controlled HIV (eg, cluster of differentiation 4 \\[CD4\\] \\> 350\u002Fmm3 and undetectable viral load)\n* Current active liver disease including hepatitis A (hepatitis A \\[HepA\\] virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA)\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* Treatment with a long-acting hematopoietic growth factor within 14 days before Cycle 1 Day 1 or a short-acting hematopoietic growth factor within 7 days before Cycle 1 Day 1\n* Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days before Cycle 1 Day 1\n* Patients with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroid throughout this indication for at least 4 weeks before starting treatment in this study\n* History of solid organ transplantation\n* Coronavirus disease 2019 (COVID-19) vaccination within 14 days prior to first dose of study drug\n* Prior treatment with a MYB inhibitor",{"count":479,"type":21},105,[24],"Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC",[37,483],"Colorectal Cancer","2025-11-12",{"date":486,"type":52},"2025-11-14",{"date":488,"type":52},"2024-08-19",{"date":490,"type":21},"2027-06",{"name":492,"class":127},"Rgenta Therapeutics Inc",10,{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":204},"100430330","stereotactic-body-radiotherapy-sbrt-for-early-treatment-of-oligometastatic-adenoid-cystic-carcinoma-the-solar-trial-100430330","NCT04883671","Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial","Inclusion Criteria:\n\n* Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on imaging (biopsy of metastatic disease preferred, but not required)\n* Cohort 1\n\n  * One to five detectable sites of metastatic disease at any organ or site (including bone and CNS involvement)\n\n    * Maximum size of 3 cm for brain lesions.\n    * Note: Measurable disease is not required\n    * Note: Patients with isolated intracranial disease for whom SRS would be the preferred standard of care are not eligible.\n    * Note: Patients may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3 months as determined by the investigator\n* Cohort 2\n\n  * At least 1 site of non-osseous disease\n* Cohort 1\n\n  * All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose \u002F dose constraints (there is no prespecified minimum or maximum size)\n* Cohort 2\n\n  * At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization\n* Cohort 1\n\n  * Primary tumor either controlled, or amenable for local treatment with SBRT\n  * Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment\n* Age 18 years or older\n* ECOG performance status of 0-2\n* Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT.\n* Cohort 1\n\n  * For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation):\n\n    * If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site\n    * If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy.\n\n\"Women of childbearing potential (WOCBP)\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n\n* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.\n\nExclusion Criteria:\n\n* Cohort 1\n\n  * Subject who has received systemic therapy for treatment of ACC within 2 weeks of enrollment.\n* Evidence of need for urgent surgical intervention for metastatic CNS or spine disease.\n* Cohort 1\n\n  * Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or \\[chemo\\]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of SBRT.\n* Bone metastasis in a femoral bone for which surgical stabilization is recommended.\n* Cohort 1\n\n  * Active disease \\>1 cm that is progressing and not amenable to SBRT.\n* Pregnant or lactating women.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.",{"count":82,"type":21},[502],"NA","The aim of this study is to learn whether the early initiation of a specialized and focused type of radiation called stereotactic body radiation therapy (SBRT) will impact the progression of advanced adenoid cystic carcinoma, quality of life, and overall survival.\n\nThe name(s) of the study intervention involved in this study is:\n\n* Stereotactic Body Radiation Therapy (SBRT)",[37,86],[37,86],"2025-09-22",{"date":508,"type":52},"2025-09-23",{"date":510,"type":52},"2021-12-27",{"date":512,"type":21},"2030-06-01",{"name":514,"class":100},"Dana-Farber Cancer Institute",{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":532,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":204},"100578017","phase-1-a-study-of-the-c-kit-specific-antibody-drug-conjugate-nn3201-for-advanced-andor-metastatic-solid-tumors-known-to-express-c-kit-100578017","NCT06805825","A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","Key Inclusion Criteria:\n\nSubjects must meet the following criteria to be eligible for enrollment into the study:\n\n1. Histologically or cytologically confirmed locally advanced, metastatic, and\u002For unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.\n2. Subjects must have received the following treatment:\n\n   Part A (Dose Escalation):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib)\n\n   or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET ChRCC or ccRCC)\n\n   Part B (Dose Expansion):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or\n\n   iii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or ChRCC or ccRCC).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.\n5. Age ≥ 18 years.\n6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).\n7. Adequate heart function as measured by ECHO\u002FMUGA scan.\n8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:\n\n   1. Cytotoxic chemotherapy - At least 21 days\n   2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n   3. Nitrosoureas - At least 6 weeks\n   4. Monoclonal antibody(ies) - At least 28 days\n   5. Radiotherapy - At least 14 days from local site radiation therapy\n9. Negative Serum\u002Furine pregnancy test (for subjects of childbearing potential)\n10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.\n11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.\n\nKey Exclusion Criteria:\n\n1. Has received prior therapy with a c-Kit agent (except GIST subjects).\n2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n3. A condition requiring systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs (inhaled corticosteroids are allowed).\n4. Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at Study Entry, Day -2 to Cycle 1 Day 1.\n5. Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).\n6. Significant cardiovascular impairment.\n7. Significant screening electrocardiogram (ECG) abnormalities.\n8. Known active and clinically significant bacterial, fungal, or viral infection.\n9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg, despite optimal medical management.\n10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.\n11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and\u002For any identified active COVID-19 infection.\n12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.\n13. People who are pregnant or breastfeeding.\n\nOther inclusion and exclusion criteria must also be met to be eligible to participate in this study.",{"count":523,"type":21},67,[24],"This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and\u002For metastatic solid tumors known to express c-Kit.",[527,528,37,529,350,530,531],"Gastrointestinal Stromal Tumors","Small-cell Lung Cancer","Uveal Melanoma","Chromophobe Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma",[533,449,89,534,535,536,537,538,539,527,528,37,529,540,530,531,541,542,543,544,545,546],"GIST","NET","ChRCC","ccRCC","Novelty Nobility","cKit","c-kit","Neuroendicrine Tumors","advanced GIST","advanced SCLC","advanced ACC","advanced NET","advanced ChRCC","advanced ccRCC","2025-09-18",{"date":508,"type":52},{"date":550,"type":52},"2025-02-03",{"date":552,"type":21},"2027-12-31",{"name":554,"class":127},"Novelty Nobility, Inc.",{"id":556,"slug":557,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":570,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":579},"100578001","phase-2-a-phase-2-trial-of-ivonescimab-for-patients-with-advanced-metastatic-salivary-gland-cancers-100578001","NCT06805617","A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers","A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers (I-MAC)","I-MAC","Inclusion Criteria:\n\n* Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic, or advanced, unresectable disease.\n* Willing to provide tumor tissue from a diagnostic biopsy or prior surgery if deemed safe and feasible by the investigator.\n* Age 18 years or older at the time of consent. There is no upper age limit restriction in an effort to include patients across the lifespan.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participant must have organ and marrow function as defined below within 14 days prior to study registration:\n\n  * Absolute neutrophil count (ANC) ≥1000\u002FmcL\n  * Hemoglobin ≥8.5 g\u002FdL (with no blood transfusions within 7 days of start of therapy)\n  * Platelets ≥100,000\u002FmcL\n  * Liver function:\n\n    * Serum total bilirubin (T-bili) ≤1.5× upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, T-bili ≤3× ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; for patients with liver metastases, AST and ALT ≤5× ULN\n  * Creatinine Within normal limits, or Creatinine clearance (CrCl) ≥50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR)\n  * Urine protein: Urine protein \\\u003C2+ or 24-hour urine protein quantification \\\u003C1.0 g\n  * Coagulation:prothrombin time (PT) or international normalized ratio (INR) ≤1.5× ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5× ULN (unless abnormalities are unrelated to coagulopathy or coagulation)\n* Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and\u002For new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria is not required.\n* Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥1 cm with CT scans or MR imaging.\n* Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent\u002Fmetastatic SGC are permitted except receipt of a prior oral VEGFR TKI or anti-PD-1 therapy; but prior therapy for recurrent\u002Fmetastatic SGC is not required for participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of the Ivonescimab.\n* Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 120 after the last dose of Ivonescimab.\n\nExclusion Criteria:\n\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment) and have no evidence of new or enlarging brain metastases.\n* Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Pregnant or lactating women as the effects of the investigational therapy (ivonescimab) on the developing human fetus are unknown.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low- risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.\n* Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded. Patients cannot be on long-term (\\>4 weeks) corticosteroids at doses exceeding prednisone 10 mg daily (or its equivalent).\n* Major surgical procedures or serious trauma within 4 weeks prior to starting therapy or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) are permitted.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to the start of therapy, including but not limited to:\n\n  * a. Gastrointestinal bleeding\n  * b. Hemoptysis (defined as coughing up ≥0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * c. Significant nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * d. Need for therapeutic anticoagulant therapy within 14 days prior to the start of therapy.\n* Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.\n* History of major diseases , specifically:\n\n  * a. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * b. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization\n  * c. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization\n  * d. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization\n  * e. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization\n* Imaging during the screening period shows that the patient has:\n\n  * a. Radiologically documented evidence of major blood vessel invasion or encasement by cancer (per the judgment of the treatment investigator)\n  * b. Radiographic evidence of intratumor cavitation (per the judgment of the treating investigator)",{"count":564,"type":21},35,[25],"The goal of this study is to evaluate the efficacy and safety of Ivonescimab in participants with advanced, metastatic salivary gland cancers.\n\nThe name of the study drug involved in this study is:\n\n-Ivonescimab (a type of antibody)",[36,568,569,37],"Advanced Salivary Gland Carcinoma","Metastatic Salivary Gland Cancer",[36,452,569,37],"2025-07-28",{"date":573,"type":52},"2025-07-29",{"date":575,"type":52},"2025-02-26",{"date":577,"type":21},"2027-07-01",{"name":99,"class":100},2,{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":60},"100576151","phase-2-clinical-trial-of-hg146-administered-to-participants-with-adenoid-cystic-carcinoma-100576151","NCT06781567","Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma","A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.","HG146","Inclusion Criteria:\n\n* Signed informed consent form (ICF) and able to comply with study.\n* Age ≥18 years, gender unlimited.\n* Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.\n* Estimated survival \\>12 weeks, as determined by the investigator.\n* The United States Eastern Cancer Consortium (ECOG) physical status score 0-1.\n* Has adequate organ function.\n* At least 1 measurable tumor lesion according to RECISTv1.1 criteria.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.\n* Received prior therapies targeting HDAC.\n* Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment \\[small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.\n* Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.\n* Major surgery or major injury \\\u003C=28 days before the first dose of study treatment,or anticipated major surgery during the study.\n* Prior allogeneic bone marrow transplantation or other solid organ transplantation\n* Active infection requiring systemic treatment.\n* Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years.\n* A person is known to be allergic to any active ingredient or excipient of the investigational drug.\n* Pregnant or lactating women.\n* patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.",{"count":589,"type":21},140,[25],"This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.",[37,28],[586,594],"HG146CN201","2025-03-11",{"date":597,"type":52},"2025-03-14",{"date":599,"type":52},"2024-12-13",{"date":601,"type":21},"2029-06-30",{"name":603,"class":127},"HitGen Inc.",{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":158,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":60},"100378962","phase-2-adenoid-cystic-carcinoma-and-carbon-ion-only-irradiation-100378962","NCT04214366","Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation","ACCO","Inclusion Criteria:\n\n* Histologically confirmed adenoid cystic carcinoma in the head and neck area\n* Indication for irradiation:\n* non-operable or\n* R1\u002FR2 resected or\n* perineural sheat invasion (Pn+) or\n* pT3\u002FpT4\n* Informed consent\n* KI \\> 60% or ECOG 0\u002F1 (minimum: self-sufficiency, normal activity or work not possible)\n* Age 18-80 years\n\nExclusion Criteria:\n\n* rejection of the study by the patient\n* Patient is not able to consent\n* Stage IV (distant metastases), except lung metastases \\\u003C 1cm\n* lymph node involvement (clinical or pathological)\n* Previous radiotherapy in the head and neck area\n* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)\n* Contraindication to MR imaging\n* Simultaneous participation in another clinical study that could influence the outcome of this study or the other study\n* Pregnancy",{"count":612,"type":21},314,[25],"Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.",[37],[617,618,619,89,620],"carbon ion","heavy ion","salivary gland tumor","Radiation therapy","2023-11-29",{"date":623,"type":52},"2023-11-30",{"date":625,"type":52},"2019-12-01",{"date":627,"type":21},"2032-12-01",{"name":629,"class":100},"Heidelberg University"]