[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":29,"responsibleParty":63,"collaborators":18,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":18,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":18,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Bantam Pharmaceuticals","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BTM-3566","EXPERIMENTAL","Daily oral dosing (7 days on\u002F7 days off)",[13],"Drug: BTM-3566",[15],{"type":16,"name":9,"description":9,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Kapadi BTM-3566 Project Manager","CONTACT","984-849-4400","BTM3566@kapadi.com",{"name":26,"role":22,"phone":27,"phoneExt":18,"email":28},"Bantam Chief of Staff","646-598-4823","info@bantampharma.com",[30,49],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"NEXT Houston","RECRUITING","Houston","Texas","77054","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-95.36327,29.76328,{"lat":42,"lon":41},[45],{"name":46,"role":22,"phone":47,"phoneExt":18,"email":48},"Emma Clinical Trial Navigator","832-384-7912","emorales@nextoncology.com",{"facility":50,"status":32,"city":51,"state":34,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"NEXT Oncology","San Antonio","78229",{"type":39,"coordinates":54},[55,56],-98.49363,29.42412,{"lat":56,"lon":55},[59],{"name":60,"role":22,"phone":61,"phoneExt":18,"email":62},"Clinical Trial Navigator","210-580-9521","jgeorg@nextoncology.com",{"type":64,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Advanced Solid Tumors",[82,84,85],"Phase 1","Dose escalation","2025-12-10",{"date":88,"type":89},"2025-12-17","ACTUAL",{"date":86,"type":89},{"date":92,"type":76},"2027-08",{"name":5,"class":6},2]