[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,68,112],{"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":37,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176",false,"NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol","ALL","18 Years",{"count":19,"type":20},392,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[26,27,28,29,30,31,32,33,34,35,36],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","RECRUITING","2026-06-18",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2024-10-29",{"date":63,"type":20},"2028-11",{"name":65,"class":66},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)","INDUSTRY",40,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":91,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":76,"type":20},665,[23],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[46,48,80,81,82,83,84,85,86,87,88,89,90,26],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma",[40,39,41,42,48,47,92,49,50,93,94,95,96,97,98,99,100,101,102],"PDAC","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":105,"type":59},"2026-06-02",{"date":107,"type":59},"2025-03-31",{"date":109,"type":20},"2029-09",{"name":65,"class":66},17,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100542479","phase-1-open-label-study-of-bbo-8520-in-adult-subjects-with-krasg12c-non-small-cell-lung-cancer-100542479","NCT06343402","Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n\nExclusion Criteria:\n\n* Patients with malignancy within the last 2 years as specified in the protocol\n* Patients with untreated or unstable brain metastases\n* Patients with known hypersensitivity to BBO-8520 or its excipients\n* For Cohorts 1b and 2b:\n* Patients with a known hypersensitivity to pembrolizumab or its excipients\n* Patients with active autoimmune disease of history of autoimmune disease that might recur\n* Patients with a history of interstitial lung disease\u002Fpneumonitis that required steroids, or current interstitial lung disease\u002Fpneumonitis\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":120,"type":20},350,[23],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.",[124,125,48,85,32,90],"Non-small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer","2026-05-04",{"date":128,"type":59},"2026-05-05",{"date":130,"type":59},"2024-05-22",{"date":132,"type":20},"2031-09",{"name":65,"class":66},35,""]