[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625019":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":66,"centralContacts":71,"locations":78,"responsibleParty":95,"collaborators":76,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":76,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":76,"enrollmentInfo":106,"targetDuration":76,"studyType":109,"phases":110,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":81,"whyStopped":76,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Abbisko Therapeutics Co, Ltd","INDUSTRY",[8,14,19,24,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Escalation part-400mg","EXPERIMENTAL","ABSK141 (investigational drug) tablet, 400 mg administered orally once daily (QD), continuously until disease progression.",[13],"Drug: ABSK141-400mg",{"label":15,"type":10,"description":16,"interventionNames":17},"expansion part","ABSK141 (investigational drug) tablet,Recommended Dose for Expansion (RDE) administered orally once daily (QD), continuously until disease progression.",[18],"Drug: ABSK141-Recommended Dose for Expansion (RDE)",{"label":20,"type":10,"description":21,"interventionNames":22},"Escalation part-800mg","ABSK141 (investigational drug) tablet, 800 mg administered orally once daily (QD), continuously until disease progression.",[23],"Drug: ABSK141-800mg",{"label":25,"type":10,"description":26,"interventionNames":27},"Escalation part-1200mg","ABSK141 (investigational drug) tablet, 1200 mg administered orally once daily (QD), continuously until disease progression.",[28],"Drug: ABSK141-1200mg",{"label":30,"type":10,"description":31,"interventionNames":32},"Backfill cohorts","ABSK141 (investigational drug) tablet, The decision-making on doses for backfill cohorts will be based on the discussion and alignment between the Sponsor and Investigator.",[18],{"label":34,"type":10,"description":35,"interventionNames":36},"Phase II","ABSK141 (investigational drug) tablet, administered at the Recommended Phase 2 Dose (RP2D) continuously until disease progression.",[37],"Drug: ABSK141-Recommended Phase 2 dose (RP2D)",[39,46,51,56,61],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","ABSK141-400mg","In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD).",[9],[45],"ABSK141, investigational drug",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"ABSK141-Recommended Dose for Expansion (RDE)","In the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD).",[30,15],[45],{"type":40,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"ABSK141-800mg","In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD).",[20],[45],{"type":40,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"ABSK141-1200mg","In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD).",[25],[45],{"type":40,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"ABSK141-Recommended Phase 2 dose (RP2D)","Phase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D).",[34],[45],[67],{"name":68,"affiliation":69,"role":70},"Xianjun Yu, Doctor","Fudan University","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Yu Zhang, Bachelor","CONTACT","+86-021-68912098",null,"yuco.zhang@abbisko.com",[79],{"facility":80,"status":81,"city":82,"state":76,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","201321","China","CN",{"type":87,"coordinates":88},"Point",[89,90],121.45806,31.22222,{"lat":90,"lon":89},[93],{"name":94,"role":74,"phone":76,"phoneExt":76,"email":76},"xianjun Yu, doctor",{"type":96,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100625019","phase-1-a-phase-iii-study-of-absk141-in-patients-with-advanced-solid-tumors--absk141-101--100625019",false,"NCT07417189","A Phase I\u002FII Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )","A Phase I\u002FII, Open-Label Study of ABSK141 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Patients With KRAS G12D Mutant Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients should understand, sign, and date the written informed consent form prior to screening\n2. Male or female age 18 years or older\n3. Patients with histologically confirmed locally-advanced or metastatic solid tumors .\n\nFor backfill cohorts in the escalation part:\n\n1. Patients must have the following solid tumor harboring KRAS G12D mutation:\n\n   1. Colorectal cancer (CRC);\n   2. Non-small cell lung cancer (NSCLC);\n   3. Pancreatic ductal adenocarcinoma (PDAC);\n2. Patients must have at least one measurable target lesion according to RECIST 1.1\n\nFor expansion Part:\n\n1. Patients must have the following solid tumor harboring KRAS G12D mutation:\n\n   1. Colorectal cancer (CRC);\n   2. Non-small cell lung cancer (NSCLC);\n   3. Pancreatic ductal adenocarcinoma (PDAC);\n   4. Other solid tumors;\n2. Patients must have at least one measurable target lesion according to RECIST 1.1\n\nFor phase II:\n\n1. Patients with locally advanced or metastatic solid tumors confirmed by histological examination, whose disease has progressed after standard treatment or who are intolerant to standard treatment, or for whom there is currently no standard treatment.\n2. Patients must have the following solid tumor harboring KRAS G12D mutation:\n\n   1. Colorectal cancer (CRC);\n   2. Non-small cell lung cancer (NSCLC);\n   3. Pancreatic ductal adenocarcinoma (PDAC);\n   4. Other solid tumors;\n3. Patients must have at least one measurable target lesion according to RECIST 1.1 4. ECOG performance status 0 or 1 5. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug 6. For patients participating exploration of food effect:\n\n(1) be able to eat a standardized high-fat, high caloric meal within 30 minutes (2) be able to fast for 10 hours\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the investigational product\n2. (For backfill cohorts and expansion part) Patients who were previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy\n3. Has a known additional malignancy that is progressing or has required active treatment\n4. Unable to swallow capsules or tablets or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. If any of these conditions exist, the site should discuss with the sponsor to determine patient eligibility\n5. Previous anti-tumor therapy, including chemotherapy, endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life (whichever is shorter), radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment\n6. Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence\n7. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity (CTCAE v5.0)\n8. Patients should not use proton pump inhibitors for at least 7 days prior to the first dose of ABSK141 and during treatment with ABSK141.\n9. P-gp inhibitor and strong CYP3A inhibitors to 7 days or 5 half-lives whichever is longer and for CYP3A inducers to 2 weeks or 5 half-lives\n10. Active central nervous system (CNS) metastases\n11. History of interstitial lung disease requiring systemic steroid treatment.\n12. Impaired cardiac function or clinically significant cardiac disease\n13. NSCLC cohorts: Patient previously identified as having a driver mutation (according to local standard of care or guidelines) and have not received any targeted therapy, for example: EGFR mutation, ALK rearrangement, KRAS G12C mutation, NTRK1\u002F2\u002F3 gene fusion, RET fusion, MET exon14 skipping mutation, BRAF V600E mutation, ROS1 rearrangement, etc\n14. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1\u002F2 antibody\n15. Exclusion of hepatitis infection\n16. Patients with refractory\u002Funcontrolled ascites or pleural effusion\n17. Pregnant or nursing (lactating) women\n18. refuse to use highly effective methods of birth control during the study and for up to 6 months after the last dose of study drug.\n19. Sexually active males who refuse to use a condom during intercourse while taking drug and for 5 consecutive compound half-lives plus 60 days after stopping study drug.\n20. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines\n21. Planned major surgery during study treatment\n22. Any other clinically significant comorbidities","ALL","18 Years",{"count":107,"type":108},401,"ESTIMATED","INTERVENTIONAL",[111,112],"PHASE1","PHASE2","This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I\u002FII study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.",[115],"Solid Tumors, Adult",[117,118],"ABSK141","KRAS G12D","2026-03-09",{"date":121,"type":122},"2026-03-11","ACTUAL",{"date":124,"type":122},"2026-03-02",{"date":126,"type":108},"2029-07-30",{"name":5,"class":6},1]