[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenoid-cystic-carcinoma-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenoid-cystic-carcinoma-of-the-head-and-neck":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100650939","first-in-human-multicenter-open-name-dose-increase-consolidation-method-to-study-safety-drug-level-in-blood--drug-metabolism-clinical-activity-of-oral-jbi-778-in-lung-cancer-patients-with-without-brain-metastasis-idh-mutated-who-grade-34-recurrent-glioma-salivary-glands-tumor-100650939",false,"NCT07755397","First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor","A Phase 1, Multicenter, Open-Label, Dose-Escalation\u002FConsolidation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Orally Administered JBI-778 in EGFR Mutated Lung Cancer Patients With or Without Brain Metastasis, Isocitrate Dehydrogenase (IDH) Mutated WHO Grade 3\u002F4 Recurrent Glioma and Adenoid Cystic Carcinoma (ACC)","Inclusion Criteria:\n\n1. Male or female participants aged ≥18 years.\n2. Histologically or cytologically confirmed:\n\n   1. EGFR-mutated non-small cell lung cancer (NSCLC) with or without brain metastases previously treated with an EGFR inhibitor; or\n   2. IDH-mutated WHO Grade 3\u002F4 recurrent glioma; or\n   3. Adenoid cystic carcinoma (ACC) with recurrent, metastatic, or advanced incurable disease.\n3. At least one measurable lesion according to RECIST v1.1 and\u002For RANO criteria, as applicable.\n4. ECOG performance status ≤2.\n5. Adequate hematologic, hepatic, renal, and coagulation function.\n6. Resolution of clinically significant toxicities from prior therapy to Grade 0 or 1, except permitted residual toxicities.\n7. Life expectancy of at least 3 months.\n8. Able to swallow oral medication.\n9. Availability of tumor tissue and\u002For liquid biopsy suitable for next-generation sequencing.\n10. Willing to use highly effective contraception during study participation and for at least 3 months after the last dose of study treatment.\n11. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Systemic anticancer therapy or investigational therapy within 2 weeks or 5 half-lives prior to study treatment.\n2. Major surgery within 21 days before study treatment.\n3. Radiotherapy within 4 weeks for brain metastases or within 2 weeks for other disease sites.\n4. Significant uncontrolled cardiovascular, metabolic, psychiatric, or other serious medical conditions.\n5. QTcF \\>450 msec in males or \\>470 msec in females.\n6. History of optic neuritis or optic neuropathy.\n7. Active HIV infection or active hepatitis B or C infection.\n8. Active infection requiring systemic antibiotic therapy.\n9. Use of strong CYP3A inhibitors or inducers within protocol-specified washout periods.\n10. Gastrointestinal conditions that may significantly affect drug absorption.\n11. Pregnancy or breastfeeding.\n12. Participation in another interventional clinical study.\n13. Previous treatment with JBI-778.\n14. Any condition that, in the opinion of the investigator, would place the participant at unacceptable risk or interfere with study participation.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1, multicentre, first-in-human, open-label, dose-escalation\u002Fconsolidation study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered JBI-778 in EGFR mutated lung cancer patients with or without brain metastasis, IDH mutated WHO grade 3 \u002F4 recurrent glioma and ACC with evidence of recurrent, metastatic or advanced, incurable disease arising from any primary site. A total of 42 patients will be recruited in the study. The initial dose escalation up to cohort 3 (estimate to be 160mg) or until the pharmacologically active dose is reached, whichever comes first as determined by the safety committee will be performed only in EGFR mutant NSCLC patients with or without stable cerebral metastases and ACC patients. Once this dose level is reached IDH mutant WHO grade 3 \u002F4 glioma patients will be added. Once the RP2D is determined following dose escalation, additional patients, up to 12, will be treated at that dose to obtain further safety data and preliminary efficacy. Approximately 4 to 6 sites are anticipated for the dose-escalation\u002Fconsolidation, additional sites will be evaluated as needed. Study will be initiated only after receipt of regulatory and ethics committee (EC) approval. After signing the informed consent form, the patients will undergo screening assessments to confirm eligibility. Eligible patients will be considered first for initial dose escalation and once the RP2D is determined following dose escalation, additional patients, up to 12, will be treated at that dose to obtain further safety data and preliminary efficacy. The RP2D will be establish after a detailed analysis of the totality of dose escalation data, including PK, safety, efficacy, CNS penetration based on CSF sample for study drug presence, analysis of PD markers in peripheral blood and both pre-treatment and on treatment tumor biopsies.\n\nThe duration of participation for each patient will be as follows: Screening: - Up to 21 days (-21 to 1 days); Treatment period: Treatment cycle of 21-day each. Treatment may continue for up to 2 years from the start of treatment, provided that the patient experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of the disease, unacceptable toxicity, or other reasons for study discontinuation. End of treatment (EOT)\u002F Early termination (ET) visit Safety Follow-up: 30 days after last dose Survival: Every 3 months",[26,27,28],"NSCLC Patients With EGFR Activating Mutation","Adenoid Cystic Carcinoma Metastatic","Adenoid Cystic Carcinoma of the Head and Neck","RECRUITING","2026-08-05",{"date":32,"type":33},"2026-08-10","ACTUAL",{"date":35,"type":33},"2024-08-26",{"date":37,"type":20},"2028-04",{"name":39,"class":40},"Jubilant Therapeutics India Limited","INDUSTRY",6,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100641015","phase-2-adc-and-sbrt-for-recurrentmetastatic-salivary-gland-carcinoma-100641015","NCT07579598","ADC and SBRT for Recurrent\u002FMetastatic Salivary Gland Carcinoma","Antibody-Drug Conjugate Plus Stereotactic Body Radiotherapy in Recurrent or Metastatic Salivary Gland Carcinoma - A Phase II Exploratory Study","Inclusion Criteria:\n\n1. Provide written informed consent prior to the initiation of any study-specific procedures.\n2. Male or female patients aged 18-80 years.\n3. Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and\u002For metastasis.\n4. Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.\n5. At least one measurable lesion according to RECIST version 1.1 based on imaging.\n6. Life expectancy of at least 6 months.\n7. ECOG performance status (PS) score of 0-1.\n8. Adequate organ function, defined by the following laboratory criteria: (1) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without use of granulocyte colony-stimulating factor within 14 days prior to testing; (2) Platelet count ≥ 90 × 10⁹\u002FL without transfusion within 14 days prior to testing; (3) Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin use within 14 days prior to testing; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; (6) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Patients with abnormal baseline TSH may still be eligible if total T3 (or FT3) and FT4 are within normal limits; (9) Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable); (10) Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1 Day 1). If a urine test result is inconclusive, a serum test is required. Women of non-childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; (11) Willingness and ability to comply with study procedures, including treatment, contraceptive measures, scheduled visits, and follow-up assessments.\n\nExclusion Criteria:\n\n1. Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ following curative resection).\n2. Participation in another interventional clinical study or receipt of investigational drugs\u002Fdevices within 4 weeks prior to the first dose.\n3. Prior treatment with ADC agents.\n4. Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.\n5. Known hypersensitivity to the active ingredients or excipients of the study drug.\n6. Failure to recover from toxicities and\u002For complications caused by prior interventions to ≤ Grade 1 or baseline (excluding fatigue or alopecia) prior to treatment initiation.\n7. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive).\n8. Untreated active hepatitis B infection (defined as HBsAg positive with HBV-DNA levels above the upper limit of normal for the study center laboratory). Note: Patients with hepatitis B may still be eligible if: (1) HBV viral load \\\u003C 2.5 × 10³ copies\u002FmL (500 IU\u002FmL) prior to first dosing, and patients receive anti-HBV therapy throughout the study; (2) Patients with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load do not require prophylactic anti-HBV therapy but must be closely monitored for viral reactivation.\n9. Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).\n10. Pregnant or breastfeeding women.\n11. Presence of any severe or uncontrolled systemic disease, including but not limited to: (1) Significant and symptomatic abnormalities in cardiac rhythm, conduction, or morphology on resting ECG that are difficult to control, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) class ≥ II; (3) Any arterial thrombosis, embolism, or ischemic event within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack); (4) Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to the first dose, or presence of unhealed wounds, ulcers, or fractures. Tissue biopsy or minor surgical procedures within 7 days prior to first dosing are also exclusionary, except for venous catheter placement for infusion; (5) Poorly controlled hypertension (systolic \\>140 mmHg and\u002For diastolic \\>90 mmHg); (6) Active pulmonary tuberculosis; (7) Active or uncontrolled infections requiring systemic therapy; (8) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis; (10) Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL); (11) Proteinuria ≥ ++ on urinalysis confirmed by 24-hour urinary protein \\>1.0 g; (12) Psychiatric disorders that interfere with treatment compliance; (13) Any medical history, disease condition, treatment, or laboratory abnormality that may interfere with study results or the patient's full participation, or any other condition deemed unsuitable for enrollment by the investigator.","80 Years",{"count":51,"type":20},40,[53],"PHASE2","This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors.\n\nTumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued.\n\nTreatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.",[28,56,57],"SBRT","Antibody-drug Conjugates","NOT_YET_RECRUITING","2026-05-05",{"date":61,"type":33},"2026-05-12",{"date":63,"type":20},"2026-05-01",{"date":65,"type":20},"2027-12-12",{"name":67,"class":68},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100631968","a-multi-omics-approach-to-disclose-progression-and-underlying-biology-of-head-and-neck-adenoid-cystic-carcinoma-100631968","NCT07507578","A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma","A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma (MAPPING-ACC)","MAPPING-ACC","Inclusion Criteria:\n\n* Pathologic diagnosis of ACC\n* Primary ACC arising from the head and neck\n* Unequivocal clinical and\u002For radiological evidence of metastatic disease\n* Patient ability and availability to comply with study protocol procedures.\n\nExclusion Criteria:\n\n* ACC patients with local and\u002For regional recurrence without distant metastases\n* Primary ACC arising from any non-head and neck region (e.g., breast, lung, skin etc)\n* Insufficient data about previous medical history.",{"count":78,"type":20},114,"OBSERVATIONAL","The goal of this observational study is to better understand why some people with metastatic adenoid cystic carcinoma (ACC) of the head and neck have slow-growing disease while others have faster-growing or more aggressive disease. Researchers want to learn how the biology of the tumor relates to each person's clinical risk group, which is based on a published prediction tool (a nomogram).\n\nThe main question the study aims to answer is: Do people in the high-risk and low-risk groups have different biological tumor types (called ACC-I and ACC-II) when their primary tumor is tested?\n\nThe study will also look at other important questions, such as:\n\n* Do metastatic tumors show the same biological type as the original tumor?\n* Do biological types differ based on where metastases grow or how early or late they appear?\n* Are biological types linked to how well systemic treatments work?\n* Can blood tests (including DNA fragments or small RNA molecules in the blood) show the same tumor biology and help track how the cancer changes over time?\n\nParticipants will:\n\n* Allow researchers to study samples of tumor tissue taken in the past during standard care.\n* Give blood samples at study entry and then every 6 months for up to 2 years.\n* Continue all medical treatments and follow-up visits as decided by their own care team.\n* Receive no study treatment; this study only collects information and samples.\n\nAbout 114 adults with metastatic ACC of the head and neck will join the study. People with only local or regional recurrence (without metastases) or those whose primary tumor started outside the head and neck cannot take part.\n\nThe information gathered may help researchers understand why ACC behaves differently from person to person, identify new biological markers in blood, and support future personalized treatment strategies for people with metastatic ACC.",[82,28],"Adenoid Cystic Carcinoma of the Salivary Gland","2026-03-27",{"date":85,"type":33},"2026-04-02",{"date":87,"type":33},"2025-03-01",{"date":89,"type":20},"2028-12-31",{"name":91,"class":68},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",1]