[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-adenoid-cystic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-adenoid-cystic-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100498795","phase-1-cb-103-with-either-lenvatinib-or-abemaciclib-in-patients-with-notch-acc-100498795",false,"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","ALL","18 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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))",[27,28,29],"Adenoid Cystic Carcinoma","Metastatic Adenoid Cystic Carcinoma","Recurrent Adenoid Cystic Carcinoma",[27,28,29,31],"ACC","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2023-06-01",{"date":40,"type":20},"2028-06-01",{"name":42,"class":43},"Glenn J. Hanna","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"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":53,"type":20},125,[23,24],"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)",[27,28,29],"2026-06-23",{"date":59,"type":36},"2026-06-24",{"date":61,"type":36},"2023-12-20",{"date":63,"type":20},"2027-09-30",{"name":65,"class":66},"Remix Therapeutics","INDUSTRY",9,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"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":19,"type":20},[76],"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)",[27,28],[27,28],"2025-09-22",{"date":82,"type":36},"2025-09-23",{"date":84,"type":36},"2021-12-27",{"date":86,"type":20},"2030-06-01",{"name":88,"class":43},"Dana-Farber Cancer Institute",5]