[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-adenoid-cystic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-adenoid-cystic-carcinoma":29},{"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":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100633052","phase-2-sacituzumab-tirumotecan-in-recurrentmetastatic-adenoid-cystic-carcinoma-and-papillary-thyroid-carcinoma-strap-100633052","NCT07521670","Sacituzumab Tirumotecan in Recurrent\u002FMetastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP)","A Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Patients With Recurrent\u002FMetastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP, ATLAS2501 NCCH2413\u002FMK016)","STRAP","Inclusion Criteria:\n\nCommon Eligibility Criteria for Cohorts A and B\n\n1. Unresectable locally advanced or recurrent\u002Fmetastatic adenoid cystic carcinoma or papillary thyroid carcinoma.\n2. Trophoblast cell-surface antigen 2 (TROP2) expression testing by immunohistochemistry or other methods is not required for enrollment. Provision of archival tumour tissue (where available) will be requested to support retrospective analysis. Waiver for tissue submission may be granted by the Steering Committee on a case-by-case basis if archival tissue is unavailable or insufficient for analysis.\n3. Age ≥18 years at the time of enrollment (≥21 years in Singapore)\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. At least one target lesion \\*identified on contrast-enhanced CT (head, neck, chest, abdomen, pelvis with ≤5 mm slice thickness) performed within 14 days prior to enrollment (same day of the week within 14 days is acceptable; this applies similarly to other time-based criteria below).\n\n   \\* A non-lymph node lesion with a longest diameter of ≥10 mm or a lymph node lesion with a short axis of ≥15 mm\n6. No prior treatment with Trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates or antibody-drug conjugates containing anti-topoisomerase I agents.\n7. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or pre-treatment baseline level (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n8. No administration of anticancer therapies (e.g., chemotherapy, targeted therapy, immunotherapy) within 13 days prior to enrollment.\n9. No major surgery under general anesthesia within 27 days prior to enrollment.\n10. No radiotherapy (including Gamma Knife or CyberKnife) within 13 days prior to enrollment. Thirteen days or fewer of palliative radiotherapy for non-CNS disease prior to enrollment is permitted. The last radiotherapy treatment must have been performed at least 7 days before enrollment.Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n11. Laboratory values within the following criteria based on testing within 14 days prior to enrollment.\n\n    1. Neutrophil count≥1,500\u002Fmm3\n    2. Platelet count≥10x10\\^4\u002Fmm3\n    3. Hemoglobin≥9.0 g\u002FdL\n    4. AST\\\u003C100 U\u002FL\n    5. ALT\\\u003C100 U\u002FL\n    6. Total bilirubin\\\u003C1.5 mg\u002FdL\n    7. Creatinine\\\u003C1.5 mg\u002FdL, if \\>1.5 mg\u002FdL, estimated creatinine clearance ≥30 ml\u002Fmin. If an estimated value is used, it should be calculated using the Cockcroft-Gault formula.\n12. Peripheral oxygen saturation (SpO₂) ≥92% on room air within 14 days prior to enrollment.\n13. For male patients: Must agree to use acceptable contraception (refer to Notes 1,2,3) and refrain from sperm donation for at least 120 days after the last dose of study drug.\n\n    For female patients: Must not be pregnant or breastfeeding and must meet one of the following conditions:\n    1. Not of childbearing potential; or\n    2. If of childbearing potential:\n\n       * Agrees to use effective contraception (refer to Note 2) from the time of informed consent through at least 210 days after the last dose of study drug. If breastfeeding, agrees to discontinue breastfeeding from the first dose of the study drug through at least 10 days after the last dose.\n       * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 19.3.2 of the study protocol during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction. The length of time required to continue contraception for each study intervention is: sac-TMT: 210 days\n       * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n       * Additional requirements for pregnancy testing during and after study intervention are in Appendix 19.3 of the study protocol\n       * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\n    Note 1: The patient must not be currently pregnant and, when engaging in penile-vaginal intercourse with a partner who is capable of becoming pregnant, must use a condom (male or female type). In addition, because condoms may break or leak, the partner must also use an additional effective contraceptive method (see Appendix 19.3.3 of the study protocol).\n\n    Note 2: The use of contraception must comply with local regulations regarding contraceptive practices for clinical trial participants. If local labeling requirements related to study treatment are more stringent than the above, those local requirements must be followed.\n\n    Note 3: If the patient is confirmed to be azoospermic-either due to vasectomy or secondary to a medical condition-based on medical records, physical examination, or medical history as documented by site personnel, additional contraception is not required.\n14. Written informed consent obtained from the patient.\n\n    Cohort A-Specific Eligibility Criteria\n15. Diagnosis of adenoid cystic carcinoma of salivary gland origin confirmed by histological examination of the primary or metastatic lesion and the diagnosis has been confirmed by central pathology review, based on pathological images of the primary or metastatic lesion (including virtual slides or low- and high-power images of H\\&E-stained specimens).\n16. No history of receiving two or more lines of systemic anticancer therapy (excluding adjuvant therapy). Due to no standard care for these patients, patients without prior systemic therapy may also be included.\n17. Tumor growth has been observed within the past 6 months.\n\n    Cohort B-Specific Eligibility Criteria\n18. Diagnosis of PTC confirmed by histological examination of the primary or metastatic lesion. If this histological diagnosis was performed at the referring institution (i.e., a center not participating in the study), it must be reviewed and verified by a pathologist at the participating study site.\n19. Patients must have received at least one prior line of standard therapy for recurrent\u002Fmetastatic disease and no more than two prior lines (RAI therapy is not counted as a prior line).\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) metastases - including brain metastases, carcinomatous (leptomeningeal) meningitis, or symptomatic spinal metastases that require radiotherapy or surgical intervention. However, patients with previously treated brain metastases may be enrolled if imaging performed at screening shows radiographic stability for at least 28 days with no evidence of progression, they are clinically stable, and they have not required steroid therapy for at least 14 days before enrollment.\n2. Clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.\n3. Has a current and past history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, prior treatment history with cardiotoxic agents and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before enrollment.\n5. Received a live or live-attenuated vaccine within 30 days before enrollment. Administration of inactivated vaccines are allowed.\n6. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n   Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4.\n7. Is currently participating in another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n8. Has received an investigational agent or has used an investigational device within 28 days before enrollment.\n9. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n   Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n   Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n10. Has an active infection requiring systemic therapy except those permitted in the exclusion criteria 15), 16), and 17) (e.g., HIV, HBV, HCV)\n11. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n12. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n13. Has had major surgery or significant traumatic injury within 27 days before enrollment. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n    Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n14. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n15. Participants with HIV infection will be excluded unless all of the following conditions are met:\n\n    1. Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    2. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening\n    3. Absence of any AIDS-defining opportunistic infections within the past 12 months\n    4. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before registration and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n16. Positive for HCV RNA, or, if HCV RNA is negative, has not completed curative antiviral therapy at least 28 days prior to enrollment. HCV RNA testing is required only for patients who test positive for HCV antibodies or as mandated by local regulations.\n17. Positive for HBs antigen, or negative for HBs antigen but positive for either HBs antibody or HBc antibody and positive for HBV DNA quantification. Patients are eligible if HBV DNA is below the lower limit of quantification; however, they will be excluded if they have not received at least 4 weeks of antiviral therapy prior to enrollment.\n18. Patients with active gastrointestinal ulcers.","99 Years",{"count":78,"type":20},68,[24],"This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) monotherapy in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) of salivary gland origin and papillary thyroid carcinoma (PTC). A total of 68 patients will be enrolled over in 18-month period, with 34 patients in Cohort A (ACC) and 34 in Cohort B (PTC). All participants will receive sac-TMT at a dose of 4 mg\u002Fkg administered intravenously on Days 1 and 15 of each 28-day cycle.\n\nThe primary endpoint is the objective response rate (ORR), defined as the proportion of patients achieving a complete or partial response as assessed by the site investigators. Secondary endpoints include progression-free survival, overall survival, disease control rate, safety and tolerability, dose intensity, and relative dose intensity.",[29,82,83],"Adenoid Cystic Carcinoma Metastatic","Papillary Thyroid Carcinoma",[85,86,87,27,83],"Sacituzumab Tirumotecan","Recurrent","Metastatic","NOT_YET_RECRUITING","2026-04-07",{"date":91,"type":36},"2026-04-13",{"date":93,"type":20},"2026-05",{"date":95,"type":20},"2028-10-31",{"name":97,"class":43},"National Cancer Centre, Singapore",7]