[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bantam Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100613414","phase-1-btm-3566-in-advanced-solid-tumors-100613414",false,"NCT07266285","BTM-3566 in Advanced Solid Tumors","A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Any advanced, unresectable and\u002For metastatic solid tumors except for primary brain cancer, breast cancer, prostate cancer, pancreatic cancer, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, or ocular or cutaneous melanoma.\n* Must be refractory\u002Frelapsed after all standard therapies known to provide proven clinical benefit\n* ECOG Performance Status 0 to 2\n* Adequate organ function as defined by pre-specified laboratory values\n* Life expectancy \\> 3 months\n* Women of child-bearing potential (or males with female partners of child-bearing potential) must agree to use adequate contraceptive measures throughout the study and for 90 days following last dose\n\nKey Exclusion Criteria:\n\n* Has not completed appropriate wash-out timeframes of prior anti-cancer treatments\n* Has ongoing toxicities from prior anti-cancer treatments\n* Has symptomatic or uncontrolled neurologic disease\n* Has active and clinically significant bacterial, fungal or viral infection\n* Cannot avoid use of moderate or strong CYP3A4 inhibitors or inducers; CYP2C19 substrates or OAT2 substrates with narrow therapeutic index; or drugs that prolong the QT interval throughout the study\n* Has previously received a total anthracycline dose ≥ 360mg\u002Fm2 doxorubicin or equivalent\n* Has a history of serious cardiac conditions or pulmonary or cerebrovascular events within 6 months of first dose\n* Is pregnant or breastfeeding","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn about what doses of BTM-356 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of BTM-3566 are in treating cancer. The main questions it aims to answer are:\n\nWhat adverse events and toxicities (harmful side effects) are associated with different doses of BTM-3566? What are the blood levels of BTM-3566 in your body at different timepoints? What effect does BTM-3566 have on reducing tumor size and\u002For preventing the worsening of cancer? All participants will receive BTM-3566 and none will receive placebo (a look-alike substance that contains no drug).\n\nParticipants will:\n\n* Take BTM-3566 for 7 days, then take a 7 day break. This 2 week dosing schedule of 7 days on\u002F7 days off will continue until your disease worsens or you cannot tolerate treatment.\n* Visit the clinic approximately 7 times during screening and the first month of treatment. Visits will be reduced to approximately 2 visits per month after.\n* Keep a diary of when (and how much) BTM-3566 you take, along with how much you weigh on each dosing day.",[26],"Advanced Solid Tumors",[26,28,29],"Phase 1","Dose escalation","RECRUITING","2025-12-10",{"date":33,"type":34},"2025-12-17","ACTUAL",{"date":31,"type":34},{"date":37,"type":20},"2027-08",{"name":39,"class":40},"Bantam Pharmaceuticals","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100577010","phase-1-phase-1-trial-of-btm-3566-in-relapsedrefractory-mature-b-cell-lymphomas-100577010","NCT06792734","Phase 1 Trial of BTM-3566 in Relapsed\u002FRefractory Mature B Cell Lymphomas","Phase 1A\u002F1B Trial of BTM-3566 in Relapsed\u002FRefractory Mature B Cell Lymphomas","Inclusion Criteria:\n\n* must be age ≥18 years\n* must have a diagnosis of relapsed or refractory mature B cell lymphoma\n* must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)\n* must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* must have a predicted life expectancy of ≥3 months\n* must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566\n\nExclusion Criteria:\n\n* has primary CNS lymphoma\n* has ongoing toxicities from prior anti-cancer treatment \\> Grade 1\n* has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation\n* has received any anti-cancer therapy (including radiation of curative intent) \\\u003C28 days prior to administration of BTM-3566\n* has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).\n* is pregnant or breastfeeding",{"count":49,"type":20},24,[23],"The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:\n\nWhat are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?\n\nParticipants will:\n\nTake BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight",[53],"Lymphoma, B-Cell","2025-09-15",{"date":56,"type":34},"2025-09-18",{"date":58,"type":34},"2025-02-14",{"date":60,"type":20},"2027-12",{"name":39,"class":40},1,""]