[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613414":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":48,"overallOfficials":33,"centralContacts":52,"locations":62,"responsibleParty":96,"collaborators":33,"id":98,"slug":33,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":33,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":33,"enrollmentInfo":106,"targetDuration":33,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":65,"whyStopped":33,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Bantam Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Frequency and type of dose limiting toxicities","Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566","28 days",{"measure":14,"description":15,"timeFrame":16},"Frequency and severity of adverse events","Frequency and severity of adverse events according to NCI-CTCAE v 5.0","Through study completion, estimated 2 years",[18,22,25,27,29,31],{"measure":19,"description":20,"timeFrame":21},"Pharmacokinetic properties of BTM-3566","Plasma concentration of BTM-3566 at each time point","30 days",{"measure":23,"description":24,"timeFrame":16},"Clinical activity of BTM-3566","Objective Response Rate by RECIST 1.1",{"measure":23,"description":26,"timeFrame":16},"Progression Free Survival per RECIST 1.1 principles",{"measure":23,"description":28,"timeFrame":16},"Overall Survival",{"measure":23,"description":30,"timeFrame":16},"Clinical Benefit Rate (proportion of patients having at least stable disease) according to RECIST 1.1 principles",{"measure":23,"description":32,"timeFrame":16},"Duration of Response, per RECIST 1.1 principles",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","This study is a phase 1, open label, dose escalation study using single participant cohorts followed by 3+3 design to evaluate multiple ascending doses of BTM-3566.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"BTM-3566","EXPERIMENTAL","Daily oral dosing (7 days on\u002F7 days off)",[47],"Drug: BTM-3566",[49],{"type":50,"name":43,"description":43,"armGroupLabels":51,"otherNames":33},"DRUG",[43],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":33,"email":57},"Kapadi BTM-3566 Project Manager","CONTACT","984-849-4400","BTM3566@kapadi.com",{"name":59,"role":55,"phone":60,"phoneExt":33,"email":61},"Bantam Chief of Staff","646-598-4823","info@bantampharma.com",[63,82],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"NEXT Houston","RECRUITING","Houston","Texas","77054","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-95.36327,29.76328,{"lat":75,"lon":74},[78],{"name":79,"role":55,"phone":80,"phoneExt":33,"email":81},"Emma Clinical Trial Navigator","832-384-7912","emorales@nextoncology.com",{"facility":83,"status":65,"city":84,"state":67,"zip":85,"country":69,"countryCode":70,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"NEXT Oncology","San Antonio","78229",{"type":72,"coordinates":87},[88,89],-98.49363,29.42412,{"lat":89,"lon":88},[92],{"name":93,"role":55,"phone":94,"phoneExt":33,"email":95},"Clinical Trial Navigator","210-580-9521","jgeorg@nextoncology.com",{"type":97,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":107,"type":108},30,"ESTIMATED","INTERVENTIONAL",[111],"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.",[114],"Advanced Solid Tumors",[114,116,117],"Phase 1","Dose escalation","2025-12-10",{"date":120,"type":121},"2025-12-17","ACTUAL",{"date":118,"type":121},{"date":124,"type":108},"2027-08",{"name":5,"class":6},2]