[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phase-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phase-ii":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,68,89,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100650909","a-phase-ii-study-of-ivonescimab-combined-with-intraperitoneal-paclitaxel-in-patients-with-high-grade-metastatic-appendiceal-adenocarcinoma-aa-100650909",false,"NCT07753824","A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)","Inclusion Criteria\n\n* Age 18 years and above. There will be no upper age restriction\n* ECOG performance status 0-2\n* Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ.\n* Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy.\n* Participants must have adequate nutrition and normal bowel motility and function as evidenced by albumin \\> 3.0 and no history of intestinal bypass or diverting enterostomy.\n* Demonstrate adequate organ function as determined by the following requirements:\n\n  o Hematology\n* No use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3 (ANC ≥ 1000\u002Fmm3 for African American participants)\n* Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3)\n* Hemoglobin ≥ 9.0 g\u002FdL.\n\n  o Kidney:\n* 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 body surface area \\[BSA\\] is not required for eGFR). \\*CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n\n  o Liver:\n* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for participants with confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 x ULN\n* Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN\n* Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial thromboplastic time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to participants who are not on therapeutic anti-coagulation. Participants receiving therapeutic anti-coagulation should be on a stable dose\n* The effects of PTX and Ivonescimab on the developing human fetus are unknown. Taxane agents are known to be teratogenic. Additionally, based on Ivonescimab's mechanism of action, it may cause fetal harm if administered to a pregnant woman. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after the last dose of Ivonescimab. (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n  * History of hysterectomy or bilateral salpingo-oophorectomy\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n  * History of bilateral tubal ligation or another surgical sterilization procedure\n* Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 6 months after last dose of Ivonescimab or chemotherapy. Male participants with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of treatment period until 6 months after last dose of Ivonescimab.\n* Female participants of childbearing age must have a negative serum pregnancy test result before enrollment and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n* Metastases outside the peritoneal cavity, with exception of limited metastases to the thoracic cavity and\u002For limited retroperitoneal lymphadenopathy\n* Previous surgery that would preclude safe diagnostic laparoscopy with port placement\n* Current presence of significant radiographic or clinical\u002Fradiographic manifestations of gastrointestinal obstruction. 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 enrollment\n* Recent history (within the last 30 days) of large volume ascites requiring repeated paracenteses. Large-volume ascites that has resolved with prior systemic therapies is not considered Exclusionary.\n* Unresolved clinically significant toxicity of greater than or equal to NCI CTCAE v. 6.0 grade 2 attributed to any prior therapies (excluding anemia, lymphopenia, alopecia, skin pigmentation).\n* Other prior malignancy unless the participant has undergone curative therapy with no evidence of disease recurrence within 3 years prior to enrollment. The following malignancies will be allowed without the 3-year interval after adequate treatment: basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured\n* Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.\n* Palliative local therapy for non-target lesions and non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc.) within 2 weeks before the first dose.\n* Any prior clinically significant or active autoimmune disease requiring systemic therapy (e.g., with disease- modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy or immunomodulatory agents \\[e.g., infliximab or IVIG\\]) within 2 years prior to enrollment; however, replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* History of major diseases before enrollment, specifically:\n\n  * Unstable angina, myocardial infarction, CHF (New York Heart Association \\[NYHA\\] classification ≥Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, fistula, intra-abdominal abscesses, or ≥ Grade 3 acute gastrointestinal bleeding within 6 months before enrollment\n  * History of any grade arterial thromboembolic event (ATE), Grade 3 and above venous thromboembolism (VTE), as specified in NCI CTCAE6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollmentAcute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the Investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B).\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the Investigator). Minor local procedures within 3 days prior to enrollment (excluding central venous catheterization and port implantation).\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Clinically significant gastrointestinal bleeding such as hematochezia of approximately 1 tablespoon or more per day or any episodes of melena or documented acute hemoglobin drop of more than 1 gm in 2 weeks prior to enrollment\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of fulldose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* History of non-infectious pneumonia requiring systemic corticosteroids. History of or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Participants with known active tuberculosis (TB) and suspected active TB need to be ruled out by clinical examination.\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Participants with active hepatitis B are required to have stable or declining levels of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for 1 month prior to enrollment. All active hepatitis C participants (hepatitis C virus \\[HCV\\] positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known hypersensitivity to any component of any of the study drugs; known history of severe hypersensitivity reactions to other monoclonal antibodies.\n* History or current evidence of any condition (medical \\[including AEs from prior anti- cancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including current substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the participant to participate, in the opinion of the treating Investigator\n* Pregnant women are excluded from this study because both paclitaxel and Ivonescimab have 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 with these agents, breastfeeding should be discontinued.\n* Participant is breastfeeding or plans to breastfeed during the study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).",[25,26,27,28,29,30],"Phase II","Ivonescimab","Intraperitoneal","Paclitaxel","High Grade Metastatic","Appendiceal Adenocarcinoma","NOT_YET_RECRUITING","2026-08-13",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":19},"2027-01-16",{"date":39,"type":19},"2032-11-28",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100650089","phase-2-stomp-out-a-phase-2-study-to-evaluate-the-effects-of-ivonescimab-in-patients-with-unresectablemetastatic-adrenocortical-carcinoma-acc-or-unresectable-pheochromocytomaparaganglioma-ppgl-100650089","NCT07743138","STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable\u002FMetastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma\u002FParaganglioma (PPGL)","Eligibility Criteria\n\n1. 18 years of age or older. Because no dosing or adverse event data are currently available on the use of Ivonescimab in participants \\\u003C18 years of age, children are excluded from this study.\n2. Histological confirmation of ACC or PPGL. Histological confirmation of ACC based on either: i). Weiss Score of ≥ 3 in participants who had earlier surgical resection (Lin-Weiss-Bisceglia system will be used for oncocytic ACC) OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass \\> 4 cm invading surrounding organs or associated with distant metastases).\n3. Locally advanced or metastatic disease not amenable to surgery\n4. Participants must have measurable disease per RECIST v1.1. Participants must have a visceral or soft tissue metastasis measuring at least 10mm by the longest axis with CT scan or MRI. Nodal metastases must measure at least 15mm by short axis. Bone metastases require a soft tissue component with the longest axis being at least 10 mm to be considered measurable.\n5. Progressive disease per RECIST v1.1 as determined by the investigator within the 12 months preceding study enrollment\n6. Assessment of all known disease sites, eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, and\u002For FDG-PET scan within 28 days before the first dose of ivonescimab\n7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n8. Life expectancy of at least 3 months\n9. Organ and marrow function and laboratory values as follows within 48 hours prior to the first dose of ivonescimab:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n   2. Platelets ≥ 100,000\u002Fmm3\n   3. Hemoglobin ≥ 9 g\u002FdL, and no blood transfusion or erythropoietin stimulating agent is allowed within 7 days of enrollment.\n   4. 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). This applies only to participants who are not on therapeutic anti-coagulation. Participants receiving therapeutic anticoagulation should be on a stable dose\n   5. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For participants with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For participants with liver metastases, AST and ALT ≤ 5 × ULN\n   7. Serum albumin ≥ 2.8 g\u002Fdl\n   8. Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n      Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72) Female: Multiply above result by 0.85\n   9. Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1\n10. Capable of understanding and complying with the protocol requirements and has signed the informed consent document.\n11. Female participants of childbearing potential must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n12. Female participants of childbearing potential must have a negative pregnancy test at screening.\n\n    Female of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months. Note: females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.\n13. Female participant 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 90 daysafter the last dose of the ivonescimab.\n14. Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male participants with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n\nExclusion Criteria\n\nA subject who meets any of the following criteria is ineligible for the study:\n\n1. Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks of the start of the previous cycle or had received previous targeted therapy including small molecular tyrosine kinase inhibitors such as belzutifan, cabozantinib or lenvatinib within 2 weeks before the first dose of study treatment.\n2. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n3. Major surgical procedures or serious trauma within 4 weeks prior to enrollment 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) within 3 days prior to enrollment.\n4. Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first dose of study treatment however the following will be allowed:\n\n   1. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is permitted.\n   2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n   3. Psoriasis requiring topical treatment only, vitiligo, history of Hashimoto's thyroiditis, Grave's disease, history of radiographic diagnosis of rheumatoid arthritis without active therapy is allowed.\n5. Received radionuclide treatment (i.e. I 131 meta-iodo- benzyl guanidine) within 3 months of the first dose of study treatment\n6. Receipt of any other type of investigational agent within 28 days before the first dose of study treatment.\n7. The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.\n8. Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n9. Live vaccine or live attenuated vaccine within 4 weeks prior to planned first dose of study treatment , or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n10. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)\n11. Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6.0\n12. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Participants managed with indwelling catheters (eg, PleurX) are allowed.\n13. History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n14. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n15. Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n16. Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n18. Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to randomization. All participants with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n19. Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n20. History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the participant to participate, in the opinion of the treating investigator\n21. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution\n22. The subject has experienced any of the following:\n\n    1. clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\n    2. hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment\n    3. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n23. Radiographic evidence of cavitating pulmonary lesion(s)\n24. Tumor invading or encasing any major blood vessels with the exception of tumor thrombus associated with the primary tumor or located within the renal\u002Fadrenal vein or vena cava.\n25. Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of ivonescimab\n26. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    a. Cardiovascular disorders including i. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to first dose of study treatment ii. Congestive heart failure (CHF): New York Heart Association (NYHA) Class II, Class III or Class IV at the time of screening iii. Concurrent uncontrolled hypertension defined as sustained BP \\> 150 mm Hg systolic, or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment iv. Any history of congenital long QT syndrome v. Any of the following within 12 months before the first dose of study treatment:\n    * unstable angina pectoris\n    * clinically-significant cardiac arrhythmias\n    * stroke (including TIA, or other ischemic event)\n    * myocardial infarction\n    * CTCAE grade 3 or higher venous thromboembolism\n    * Unstable vascular disease (e.g. aortic aneurysm at risk of rupture, Moyamoya disease that required hospitalization) b. Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: i. Any of the following within 6 months before the first dose of study treatment\n    * intra-abdominal tumor\u002Fmetastases invading GI mucosa\n    * active peptic ulcer disease; participants must be completely recovered\n    * inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis; participants must be completely recovered from these conditions\n    * abdominal fistula\n    * gastrointestinal perforation\n    * bowel obstruction or gastric outlet obstruction\n    * intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with ivonescimab even if the abscess occurred more than 6 months before the first dose of study treatment. c. Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy\n27. Pregnant or breastfeeding.\n28. A previously identified allergy or hypersensitivity to components of the study treatment formulation.\n29. Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n30. Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer, cured in situ cervical carcinoma, or evidence of localized adenocarcinoma of the prostate Gleason score 6 (3+3) or 7 (3+4 or 4+3) undergoing active surveillance.\n31. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the participant inappropriate for entry into this study.",{"count":51,"type":19},20,[22],"To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.",[25,26,55,56,57,58,59],"Evaluate","Unresectable\u002FMetastatic Adrenocortical Carcinoma","ACC","Unresectable Pheochromocytoma","PPGL","2026-07-29",{"date":62,"type":35},"2026-08-03",{"date":64,"type":19},"2027-02-07",{"date":66,"type":19},"2030-05-01",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},"100648267","phase-2-phase-2-trial-of-s-531011-with-radscopal-in-previously-treated-metastatic-colorectal-cancer-100648267","NCT07720115","Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer","Eligibility Criteria\n\n1. Age ≥18 years\n2. Histologically or cytologically confirmed non-MSI-H colorectal adenocarcinoma with metastatic or locally advanced unresectable disease.\n3. Anticipated life expectancy greater than 3 months.\n4. Prior receipt of fluoropyrimidine, oxaliplatin, and irinotecan as standard-of-care chemotherapy.\n5. Presence of measurable disease per RECIST v1.1.\n6. Participants must have at least two target lesions amenable to treatment with RadScopalTM XRT, with at least one lesion amenable to HD-XRT (50 Gy in 4 fractions or 30 Gy in 5 fractions) as determined by the treating radiation oncologist. Repeat radiation with LDXRT to previously irradiated sites will be allowed at the discretion of the treating radiation oncologist.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n8. Adequate organ and marrow function as defined below:\n\n   * Absolute neutrophil count ≥1,500\u002FmcL\n   * Hemoglobin ≥9 g\u002FdL\n   * Platelets ≥100,000\u002FmcL\n   * AST and ALT ≤3x institutional upper limit (ULN). If liver enzyme abnormalities are due to underlying liver metastases, AST and ALT ≤ 5x institutional ULN Total serum bilirubin \\\u003C1.5x institutional ULN (unless Gilbert disease confirmed)\n   * Creatinine clearance ≥ 45 ml\u002Fmin by Cockcroft-Gault Formula\n9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n11. Human immunodeficiency virus (HIV)-infected participants on anti-retroviral therapy with undetectable viral load within 6 months of study enrollment are eligible.\n12. Participants should be willing to use contraception for a significant period after treatment to avoid potential harm to a fetus from residual drug exposure or genetic damage. Women of childbearing potential and men with a female partner of childbearing potential must be willing to use effective methods of contraception during the duration of study participation, and for 6 months after completion of S-531011 administration, as follows:\n\n    * Women: willing to use contraceptives with a failure rate \\\u003C1% per year when used consistently and correctly, eg, combined oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, or intrauterine device, sexual abstinence, or a vasectomized partner. Definitions that meet the criteria to not be considered of childbearing potential:\n\n      * Women \\>1 year postmenopausal (defined as 1 year or longer since last menstrual period) AND \\>55 years of age\n      * Postmenopausal women (as defined above) and \\\u003C55 years of age with a negative pregnancy test within 1 week of first dose of S-531011.\n      * Women who underwent surgical sterilization at least 3 months prior to enrollment.\n    * Men: willing to use adequate contraception treatment during the duration of study participation and for 6 months after completion of S-531011 administration. In addition, men must refrain from donating sperm during this period.\n\n14\\. Ability to understand and the willingness to sign a written informed consentdocument and to comply with study visits.\n\nExclusion Criteria\n\n1. Prior treatment with an anti-CCR8 antibody.\n2. Tumor occupying \\>80% of total liver volume, as assessed by the investigator and\u002For treating radiation oncologist.\n3. Prior XRT to the target lesion(s) selected for HD-XRT.\n4. Prior organ or tissue allograft.\n5. Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n6. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs).\n\n   Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Any anticancer therapy within the past 4 weeks before enrollment.\n8. Extended field radiation within the past 4 weeks or limited field radiation within the past 2 weeks before enrollment.\n9. Participants who have not recovered from adverse events due to prior anticancer therapy (i.e. \\>grade 2 residual toxicities) with the exception of alopecia and platinum-induced peripheral neuropathy.\n10. Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent).\n11. Presence of symptomatic leptomeningeal disease.\n12. Clinically significant cardiac, respiratory, or other medical or psychiatric conditions that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator.\n13. Pregnant women are excluded from this study because S-531011 is an agent with the potential for teratogenic or abortifacient effects.",{"count":18,"type":19},[22],"To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer.",[25,78,79,80],"S-531011","RadScopal","Metastatic Colorectal Cancer","2026-07-23",{"date":83,"type":35},"2026-07-24",{"date":85,"type":19},"2027-01-07",{"date":87,"type":19},"2031-01-01",{"name":41,"class":42},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":20,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":43},"100635189","phase-2-phase-2-study-of-imetelstat-for-patient-with-myelodysplasticmyeloproliferative-neoplasms-100635189","NCT07549451","Phase 2 Study Of Imetelstat for Patient With Myelodysplastic\u002FMyeloproliferative Neoplasms","Eligibility Criteria\n\n* Age ≥18 years as MF and CMML are very rare diseases in the pediatric population.\n* Diagnosis of MDS\u002FMPN according to WHO including:\n\n  1. CMML-1 or CMML-2 with resistance or intolerance to hydroxyurea (if myeloproliferative subtype defined by WBC \\>13x109\u002FL) or with no response or intolerance to 4 cycles of azacitidine or decitabine or relapse or progression after any number of cycles. CMML-1 Participants with Hgb \\\u003C11g\u002FdL, TSS score 20 or splenomegaly (defined as \\>5cm under the lower costal margin by physical exam or \\>12cm by imaging) in which hydroxyurea or HMA therapy is not indicated will also be eligible.\n  2. MDS\u002FMPN with neutrophilia (previous atypical CML) or MDS\u002FMPN-NOS with either \\>5% bone marrow blasts, Hgb \\\u003C11g\u002FdL or requiring transfusions, platelet count \\>450x109\u002FL, TSS symptom score 20 or splenomegaly \\>5cm under the lower costal margin (or \\>12cm by imaging).\n  3. MDS\u002FMPN with SF3B1 mutation and thrombocytosis (prior MDS\u002FMPN-RS-T) with Hgb \\\u003C11g\u002FdL or requiring transfusions or with platelet count \\>450x109\u002FL who have no response or failure to erythroid stimulating agents or who are unlikely to benefit due to endogenous erythropoietin levels \\>500mU\u002FmL or who have intolerance or resistance to hydroxyurea.\n\nParticipants having received other prior therapies including but not limited to lenalidomide, luspatercept, JAK inhibitors or HMA will also be eligible.\n\n* ECOG performance status ≤2\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or A LT \\\u003C\u002F= 3xULN unless related to disease involvement.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, G-CSF, GMCSF, Procrit, aranesp, thrombopoietin) is allowed at any time prior to cycle 1 day 1 of therapy.\n* Participant (or patient's legally authorized representative) must have signed an informed consent document indicating that the Participant understands the purpose of and procedures required for the study and is willing to participate in the study. Non-English-speaking Participants may be consented.\n* 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.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, Participants should be class 2B or better.\n* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 30 days after last dose of imetelstat therapy. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Participants who are currently receiving treatment for a malignancy (not including basal cell carcinoma,nonmelanoma skin cancer, cervical carcinoma in situ, early-stage breast cancer or localized prostate cancer treated with hormone therapy). Participants with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit or not requiring active treatment at the time of enrollment.\n* Participants who are receiving any other investigational agents within 7 days of C1D1 or who have received prior imetelstat therapy.\n* Active, uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, there is no evidence of infection worsening, such as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Platelet count \\\u003C50x109\u002FL prior to enrollment and treatment initiation except if related to either recent treatment for MDS\u002FMPN or treatment with cytotoxic therapy for any other reason.\n* Pregnant women are excluded from this study because imetelstat has 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 with these agents, breastfeeding should be discontinued if the mother is treated on study. These potential risks may also apply to other agents used in this study.\n* Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study.\n* Female Participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy within 7 days of therapy initiation.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":18,"type":19},[22],"To learn if imetelstat can help to control MDS\u002FMPNs.",[25,99,100],"Imetelstat","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","2026-04-20",{"date":103,"type":35},"2026-04-24",{"date":105,"type":19},"2026-10-08",{"date":107,"type":19},"2027-05-31",{"name":41,"class":42},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":20,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":43},"100626668","phase-2-phase-ii-trial-of-sacituzumab-tirumotecan-in-patients-with-smarcb1-deficient-renal-medullary-carcinoma-100626668","NCT07438626","Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma","Inclusion Criteria:\n\n1. Participants with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible.\n2. Participants will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.\n3. Participants must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures. 15 mm with conventional techniques or . 10 mm with more sensitive techniques such as MRI or CT scan. If the participant has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.\n4. Participants must have progressed on at least one line of prior therapy.\n5. There must be evidence of progression on or after last treatment regimen received.\n6. ECOG performance status 0-1\n\n   a. NOTE: If participant is unable to walk due to paralysis, but is mobile in a wheelchair, participants considered to be ambulatory for the purpose of assessing their performance status.\n7. Age (at the time of consent\u002Fassent): . 18 years\n8. Consent to MD Anderson companion laboratory protocols LAB02-152, PA17-0577 and PA11-1045.\n9. Participants must have adequate organ and marrow function as defined below:\n\n   Hemoglobina ≥9 g\u002Fdl (treatment allowed) Absolute neutrophil countb ≥1,500\u002F.L Platelets ≥100,000\u002F.L Total bilirubin ≤1.5 mg\u002Fdl AST(SGOT) or ALT (SGPT) ≤2.5 X institutional ULN,except in known hepatic metastasis, wherein may be ≤5 x ULN Estimated GFR (eGFR) \\>30 mL\u002Fkg\u002F1.73 m2 by Cockcroft- Gault methods or local institutional standard Coagulation: INR or PT aPTT ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants May receive transfusion within the screening period Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days\n10. Participants with controlled brain metastases are allowed on protocol if the brain metastases were surgically resected or treated with radiosurgery or Gamma knife, and are radiologically stable without recurrence or edema for at least 1 month (4 weeks) as confirmed by repeat imaging performed during study screening. Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible.\n11. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of the study drug.\n12. Women must not be breastfeeding.\n13. WOCBP must agree to follow instructions for method(s) of contraception from the time of registration for treatment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30days (duration of ovulatory cycle) for a total of 5 months post treatment completion. Men must agree to effective contraception from the time of registration for treatment to 210 days post last protocol treatment.\n\n    Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male participants who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \\\u003C 1% per year when used consistently and correctly. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 120 days after completion of sacituzumab tirumotecan administration:\n    * Refrain from donating sperm\n    * Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive metho as a condom may break or leak\n\n    The effects of sacituzumab tirumotecan on the developing human fetus are unknown. For this reason and because immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n14. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death\n2. Participants previously treated with a topoisomerase 1 inhibitor-containing ADC or TROP2-targeted ADCs such as sacituzumab govitecan are excluded.\n3. Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such as tazemetostat) within 2 weeks (14 days) prior to study Day 1 are excluded. Participants who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination immunotherapy are eligible.\n4. Participants must not be scheduled to receive another experimental drug while on this study.\n5. Participants\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-interactionstable- 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.\n6. Participants with persistent grade .2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events due to sacituzumab tirumotecan or otherwise hinder participant participation in the clinical trial.\n7. Participants, who have had a major surgery or significant traumatic injury (injury requiring \\> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, participants who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n8. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency.\n\n   * Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.\n   * Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.\n   * Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening then antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed every 12 months +\u002F- 3 months.\n   * Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n9. History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n10. History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n11. Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting.\n12. Participants who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\n\n    * Symptomatic congestive heart failure of New York heart Association Class III or IV\n    * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled symptomatic cardiac arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n    * Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.\n    * Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy.\n13. Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sacituzumab tirumotecan or that might affect the interpretation of the results of the study or render the participant at high risk from treatment complications.\n14. Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication.\n\n    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-MistR) are live attenuated vaccines and are not allowed.\n15. Female participants who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods as defined above.\n16. Any participants who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.\n17. History of allergic reactions attributed to compounds of similar chemical or biologic composition to sacituzumab tirumotecan.\n18. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":51,"type":19},[22],"To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at least 1 treatment.",[25,119,120,121],"Sacituzumab","Tirumotecan","SMARCB1-deficient Renal Medullary Carcinoma","2026-02-26",{"date":124,"type":35},"2026-03-02",{"date":126,"type":19},"2026-06-01",{"date":128,"type":19},"2030-02-01",{"name":41,"class":42}]