[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abbisko Therapeutics Co, Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":341},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,40,64,89,113,139,164,186,210,233,254,278,300,321],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100605565","phase-2-a-phase-2-clinical-study-of-combination-therapy-with-absk043-and-glecirasib-100605565",false,"NCT07164170","A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib","An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation","Inclusion Criteria:\n\n1. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.\n2. Gender was not limited patients aged ≥18 years at the time of signing the informed consent.\n3. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).\n\n   For patients in the dose-escalation cohort (Part A) of the escalation part:\n\n   Patients must have experienced disease progression following at least one line of prior standard systemic therapy, but no more than two lines of systemic therapy.\n\n   For patients in the dose confirmation cohort (Part B) of the escalation part :\n   1. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);\n   2. Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .\n\n   For patients in the expansion cohort of the expansion part :\n   1. Patients who have not received prior systemic therapy for locally advanced or unresectable\u002Fmetastatic disease;\n   2. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .\n4. Tumor tissue or blood test report confirmed KRASG12C mutation.\n5. Patients must have at least one measurable lesion as defined by RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~1.\n7. Expected survival time of ≥3 months.\n8. Patients must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.\n2. Toxicities from prior antitumor therapy have not returned to baseline or stabilized.\n3. Patients with active brain metastases.\n4. The patient currently has active interstitial lung disease.\n5. Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.\n6. Any condition requiring systemic treatment with corticosteroids.\n7. Uncontrolled or significant cardiovascular disease.\n8. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.\n9. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study","ALL","18 Years",{"count":19,"type":20},86,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.",[26],"Non-Small Cell Lung Cancer","RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-17","ACTUAL",{"date":33,"type":31},"2025-09-22",{"date":35,"type":20},"2029-07-30",{"name":37,"class":38},"Abbisko Therapeutics Co, Ltd","INDUSTRY",17,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100432078","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-absk-011-in-patients-with-advanced-solid-tumor-100432078","NCT04906434","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor","A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female, age 18 \\~ 75 (include both ends, or other age range required by local regulations or IRB).\n2. Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced HCC must satisfy:\n\n   1. BCLC stage B or C and Child-Pugh score 5\\~6\n   2. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing\n\n   Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on or intolerant to or have refused to receive or have no access to receive first line systemic therapy (by local guideline\u002Fregulation) and is unsuitable for other standard therapy(ies) (by local guideline\u002Fregulation) against HCC, and must satisfy:\n   1. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive\n   2. Patient must have at least 1 measurable lesion (RECIST V1.1)\n   3. Child-Pugh score 5\\~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention\n3. ECOG performance status 0\\~1\n4. Life expectancy ≥ 3 months\n5. 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 (without blood transfusion or medication with stimulation factors within 14 days before 1st dose):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n   2. Platelet count (PLT) ≥75×109\u002FL\n   3. Hemoglobin (Hb) ≥80 g\u002FL\n   4. Total bilirubin (TBIL) ≤1.5×ULN\n   5. Aspartate transaminase (AST) and alanine transaminase (ALT), ≤3×ULN (for patient with liver metastasis in escalation part or patient in expansion part: AST and AST ≤5×ULN)\n   6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL\u002Fmin based on Cockcroft-Gault formula\n6. Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression (HBV-DNA \\\u003C 10000 IU\u002FmL or equivalent copies\u002FmL prior to enrollment). Patients are examined every cycle to monitor HBV-DNA levels. If virus reactivation occurred for patients without anti-viral treatment when enrolled, anti-HBV therapy will be started following local practice.\n7. Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically sterilized female patients of childbearing potential must in non-lactation period, and have a negative β-HCG test result within 7 days before first administration.\n8. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product.\n2. Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).\n3. Has a known second primary malignancy required active treatment.\n4. Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \\\u003C10 mg or other equivalent glucocorticoids can be enrolled).\n5. Liver tumor volume accounts for ≥50% of the whole liver.\n6. Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea required drug treatment, etc.\n7. Severe irritable bowel syndrome requires drug therapy.\n8. Prior organ transplantation requires anti-rejection drug therapy.\n9. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \\>30%), routine chemotherapy \\\u003C4 weeks (chemotherapy with nitrosourea or mitomycin \\\u003C6 weeks); oral chemotherapy, endocrine therapy, molecular targeted therapy or immunotherapy within ≤ 5 half-life or ≤ 4 weeks (whichever is shorter).\n10. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of which inclusion criteria allowed, alopecia, vitiligo and neurotoxicity Grade ≤2 that investigator believe don't affect safety assessment.\n11. Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products) within at least 14 day prior to the first dose of the study drug.\n12. Impaired cardiac function or clinically significant cardiac disease, including any one of the following:\n\n    1. New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug;\n    2. Clinically significant cardiac arrhythmia requiring active therapy;\n    3. Uncontrolled hypertension;\n    4. Left ventricle ejection fraction\\\u003C50%\n    5. Prolongation of QTcF (average of three times of examine, male \\> 450 ms, female \\> 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening, and other ECG abnormalities with clinical significant by the judge of the investigator.\n13. Active infection or unexplained fever \\> 38.5℃.\n14. Active or record of gastrointestinal bleeding within 6 months (e.g. esophageal varices or ulcer bleeding).\n15. Patients with active HCV infection (HCV-RNA\\>103 copies\u002FmL or following local clinical practice) and require concomitant anti-HCV therapy during the study; or HBV HCV co-infection.\n16. History of immunodeficiency, including HIV serum test positive, or other acquired\u002Fcongenital immunodeficiency disease, or active tuberculosis.\n17. Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.\n18. Combined with portal vein tumor thrombus of type IV.","75 Years",{"count":49,"type":20},200,[51],"PHASE1","This is an open-label phase 1 study with an escalation part and an expansion part.",[54],"Advanced Liver Cancer","2026-04-01",{"date":57,"type":31},"2026-04-07",{"date":59,"type":31},"2020-02-26",{"date":61,"type":20},"2028-12-31",{"name":37,"class":38},32,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":39},"100377270","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-absk-021-in-patients-with-advanced-solid-tumor-100377270","NCT04192344","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor","A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n* Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists\n* ECOG (electrocorticogram) performance status 0\\~1\n* Life expectancy ≥ 3 months\n* Adequate organ function and bone marrow function\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. A diagnosis of TGCT \\[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);\n2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;\n3. Others\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)\u002FCSF-1R (colony stimulating factor 1 receptor) pathway inhibitors\n* Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment\n* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication\n* Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)\n* Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence\n* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo\n* Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug\n* Concomitant use of strong inhibitors or inducers of CYP3A4\n* Active central nervous system (CNS) metastases\n* Impaired cardiac function or clinically significant cardiac disease\n* Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study\n* Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection\n* Refractory\u002Funcontrolled ascites or pleural effusion\n* Pregnant or nursing\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product\n2. For expansion part, previous treatment with CSF 1\u002FCSF 1R pathway inhibitors (not applicable for TGCT patients in US）\n3. Others",{"count":72,"type":20},276,[51],"This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.",[76,77],"Neoplasms","Tenosynovial Giant Cell Tumor",[77,79,80],"TGCT","Solid tumors","2026-03-17",{"date":83,"type":31},"2026-03-19",{"date":85,"type":31},"2020-01-20",{"date":87,"type":20},"2026-12-31",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":112},"100625019","phase-1-a-phase-iii-study-of-absk141-in-patients-with-advanced-solid-tumors--absk141-101--100625019","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",{"count":97,"type":20},401,[51,23],"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.",[101],"Solid Tumors, Adult",[103,104],"ABSK141","KRAS G12D","2026-03-09",{"date":107,"type":31},"2026-03-11",{"date":109,"type":31},"2026-03-02",{"date":35,"type":20},{"name":37,"class":38},1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100618085","phase-2-absk-011bsc-vs-placebobsc-in-previously-treated-advanced-hcc-with-fgf19-overexpression-100618085","NCT07327034","ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression","A Randomized, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of ABSK-011 Plus Best Supportive Care (BSC) vs. Placebo Plus BSC in Previously Systemically Treated Advanced or Unresectable Hepatocellular Carcinoma Patients With FGF19 Overexpression","Inclusion Criteria:\n\n1. Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol.\n2. Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.\n3. Patients with advanced or unresectable HCC confirmed histologically\u002Fcytologically or clinically according to the American Association for the Study of Liver Diseases (AASLD) criteria (for patients with cirrhosis).\n4. Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI approved for the treatment of HCC.\n5. BCLC stage B(ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C.\n6. Child-Pugh class A.\n7. Positive for FGF19 overexpression.\n8. At least 1 measurable lesion meeting RECIST v1.1 criteria.\n9. ECOG performance status 0 or 1.\n10. Life expectancy ≥ 3 months.\n11. Adequate control of blood pressure (BP) at screening.\n12. Adequate organ function and bone marrow function.\n13. Non-surgically sterilized male or female patients of childbearing potential must agree to use reliable contraception for at least 2 weeks prior to randomization until 1 month after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Known allergies or hypersensitivity to any component of the investigational product (ABSK-011 or placebo).\n2. Previous treatment with selective FGFR4 inhibitors.\n3. Known fibrolamellar HCC, sarcomatous HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma.\n4. Previous anti-tumor therapy is ≤ 4 weeks from randomization.\n5. Major surgery within 4 weeks prior to randomization; or any surgical wound infection, dehiscence, or incomplete healing within 2 weeks prior to randomization; Or major surgery is planned during study treatment.\n6. History of second primary malignancies other than HCC within the first 5 years of screening.\n7. Liver tumors as a percentage of whole liver ≥ 50% as judged by the investigator.\n8. Toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies (including immunotherapy) did not recover to ≤ Grade 1 CTCAE v5.0.\n9. Imaging revealed HCC involving the main portal vein (Vp4), inferior vena cava, superior vena cava, superior mesenteric vein, or heart.\n10. Impaired cardiac function or clinically important heart disease.\n11. Patients coinfected with HBV and HCV.\n12. Known acquired immunodeficiency syndrome (AIDS) -associated disease or tested positive for HIV 1\u002F2 antibodies.\n13. Active or documented gastrointestinal bleeding within 6 months prior to screening.\n14. Patients with intractable\u002Funcontrolled pleural or pericardial effusion requiring intervention within 2 weeks prior to randomization and clinically significant ascites.\n15. Prior or current hepatic encephalopathy (any grade).\n16. Presence of meningeal or central nervous system (CNS) metastases.\n17. Previous organ transplant and anti-rejection drug therapy indicated.\n18. The factors that significantly affect the absorption of oral drugs.\n19. Receipt of P-gp transporter inhibitors or moderate, strong inhibitors or inducers of CYP3A4 within 2 weeks prior to randomization.\n20. Any serious acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks prior to randomization.\n21. Patient who cannot be assessed by contrast-enhanced CT and\u002For MRI due to allergy to computed tomography (CT) and\u002For magnetic resonance imaging (MRI) contrast media or other contraindications.\n22. Any other clinically significant comorbidities may affect the patient's health or safety, affect the signing of informed consent, affect protocol compliance, or interfere with the interpretation of the study results.",{"count":121,"type":20},141,[23],"This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.",[125],"Hepatocellular Carcinoma (HCC)",[127,128,129],"HCC","FGF19 overexpression","ABSK-011","2025-12-25",{"date":132,"type":31},"2026-01-08",{"date":134,"type":31},"2025-06-13",{"date":136,"type":20},"2028-06-30",{"name":37,"class":38},51,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100615843","phase-1-a-study-of-absk061-to-assess-safety-tolerability-pharmacokinetics-and-efficacy-in-children-with-achondroplasia-100615843","NCT07297875","A Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia","A Phase Ⅰ\u002FⅡ, Open-Label Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia","Inclusion Criteria:\n\n1. Prior to screening, the guardians and children with ACH (if applicable) must voluntarily provide signed informed consent.\n2. Patients with a clear clinical diagnosis of ACH confirmed by genetic testing for an FGFR3 mutation.\n3. Male or female, age at screening:\n\n   Dose Escalation Part A: 6 to \\\u003C 12 years (inclusive 6 years) Dose Escalation Part B: 3 to \\\u003C 6 years (inclusive 3 years) RDE Confirmation Part: 3 to \\\u003C 12 years (inclusive 3 years).\n4. Have completed at least 6 months (i.e., the \"Day 181\" visit) of growth assessment and observation of natural history of ACH in the observational study (ABSK061-001) before study entry.\n5. Tanner Stage 1 breast development for females or Tanner Stage 1 external genitalia development for males at screening\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the study drug.\n2. Bone age ≥ 14 years as assessed by the investigator based on hand and wrist X-ray.\n3. Have a form of skeletal dysplasia other than ACH or known medical conditions that result in short stature or abnormal growth, including but not limited to severe achondroplasia with developmental delay and acanthosis nigricans (SADDAN), Turner syndrome, pseudoachondroplasia, inflammatory bowel disease, chronic renal insufficiency, active celiac disease a, Vitamin D deficiency b, untreated hypothyroidism c, poorly controlled diabetes (HbA1c ≥8.0%) or diabetic complications\n4. History or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones.\n5. AGV ≤ 1.5 cm\u002Fyear over at least 6 months (i.e., must have completed the 'Day 181' visit) in the observational study (ABSK061-001), or current evidence of growth plate closure (proximal tibia, distal femur).\n6. Current epiphyseal injury (Salter-Harris fracture) or severe hip pain.\n7. For ACH-related complications: current severe sleep apnea, symptomatic and\u002For requiring intervention for hydrocephalus, or spinal cord compression at the cranio-cervical junction, or prior ventriculoperitoneal shunt surgery.\n8. Have received any dose of medications affecting stature or body proportionality, such as human growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids within 12 months prior to screening.\n9. Prior treatment with any CNP analogues or FGFR inhibitors. Prior use of any investigational drugs or investigational medical devices that affect height or body proportion.\n10. History of any prior bone-related surgery that affects long bone growth, such as orthopaedic reconstructive surgery, limb lengthening, or osteotomy (patients who have previously undergone foramen magnum decompression or intervertebral disc\u002Flaminectomy are allowed if they have fully recovered after surgery and bone healing has occurred for at least 6 months. Patients who have previously undergone eight-plate epiphysiodesis are allowed if the plate has been removed and healed for at least 4 weeks).","3 Years","12 Years",{"count":149,"type":20},110,[51,23],"This is a multicenter, non-randomized, open-label, phase I\u002FII study in children with ACH. This study will start with a dose escalation of ABSK061 in children with ACH to evaluate the safety, tolerability, PK, and efficacy. The RDE confirmation part will evaluate the safety and efficacy of ABSK061 at the recommended doses for expansion (RDEs) in children with ACH. All patients enrolled in the dose escalation part and RDE confirmation part can enter the extended treatment period to further evaluate the long-term safety, tolerability, and long-term efficacy of ABSK061 in children with ACH.",[153],"Achondroplasia","NOT_YET_RECRUITING","2025-12-17",{"date":157,"type":31},"2025-12-22",{"date":159,"type":20},"2025-12-10",{"date":161,"type":20},"2031-03-15",{"name":37,"class":38},7,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100616119","a-study-in-children-with-achondroplasia-100616119","NCT07301463","A Study in Children With Achondroplasia","A Multicenter, Longitudinal, Observational Study in Children With Achondroplasia","Inclusion Criteria:\n\n1. Prior to screening, the guardians and children with ACH (if applicable) must be willing and able to provide signed informed consent.\n2. Clinical diagnosis of ACH confirmed FGFR3 mutation by genetic testing.\n3. Male or female aged ≥2.5 to \\\u003C11 years old at screening.\n4. Tanner Stage 1 breast development for females or Tanner Stage 1 external genitalia development for males at screening.\n5. Ambulatory and able to stand without assistance.\n\nExclusion Criteria:\n\n1. Bone age ≥14 years as assessed by the investigator based on hand and wrist X-ray taken within 6 months prior to Day 1.\n2. Current evidence of growth plate closure (proximal tibia, distal femur), or AGV ≤ 1.5 cm\u002Fyear over a period ≥6 months prior to screening.\n3. Have a form of skeletal dysplasia other than ACH or known medical conditions that result in short stature or abnormal growth, including but not limited to severe achondroplasia with developmental delay and acanthosis nigricans (SADDAN), Turner syndrome, pseudoachondroplasia, inflammatory bowel disease, chronic renal insufficiency, active celiac disease a, Vitamin D deficiency b, untreated hypothyroidism c, poorly controlled diabetes (HbA1c ≥8.0%) or diabetic complications d.\n\n   1. Celiac disease responsive to a gluten-free diet is allowed\n   2. Vitamin D deficiency or insufficiency with a 25-hydroxyvitamin D \\[25- (OH) D\\] level ≥ 30 nmol\u002FL after supplementation is allowed. Vitamin D deficiency is defined as 25-(OH) D level \\\u003C30 nmol\u002FL. Vitamin D insufficiency is defined as 25-(OH) D level 30\\~50 nmol\u002FL. Patients with Vitamin D deficiency or insufficiency must be on Vitamin D regimen prior to screening\n   3. Patients with hypothyroidism meeting the following criteria are allowed to enroll: must be clinically euthyroid for one month prior to screening and, in the opinion of the investigator, have achieved any catch-up growth expected from thyroxine replacement\n   4. Patients with diabetes must have been on stable medication regimen for 3 months prior to screening\n4. History or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones.\n5. Impaired cardiac function or clinically significant cardiovascular disease, including any one of the following: New York Heart Association class II or higher heart disease, congenital heart disease (patients with repaired uncomplicated patent ductus arteriosus or atrial\u002Fventricular septal defect with repair are allowed), clinically significant arrhythmias requiring therapy, aortic regurgitation, congestive heart failure, or any other uncontrolled heart disease.\n6. For ACH-related complications: Current severe sleep apnea, symptomatic and\u002For requiring intervention for hydrocephalus, or spinal cord compression at the cranio-cervical junction, and has previously undergone ventriculoperitoneal shunt surgery.\n7. Bone fracture within 6 months prior to screening (within 2 months for finger and toe fractures).\n8. Have received any dose of medications affecting stature or body proportionality, such as human growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids within 3 months prior to screening, or long-term treatment (\\>3 months) with the above drugs at any time.\n9. Prior treatment with any CNP analogues or FGFR inhibitors. Prior use of any investigational drugs or investigational medical devices that affect stature or body proportionality.\n10. Any comorbidities, disease or condition that, in the opinion of the investigator, may make the patient unlikely to fully complete the study-related procedures, may affect protocol compliance.","30 Months","11 Years",{"count":174,"type":20},260,"OBSERVATIONAL","The goal of this observational study is to collect the anthropometric parameters, clinical characteristics, related medical complications, health-related quality of life and treatments of children with ACH, and complete a natural history observation of ACH for at least 6 months and up to 2 years.",[153],{"date":179,"type":31},"2025-12-24",{"date":181,"type":31},"2025-06-20",{"date":183,"type":20},"2039-04-30",{"name":37,"class":38},8,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":209,"locationsCount":112},"100615157","phase-1-a-early-study-of-absk131-in-patients-with-advancedmetastatic-solid-tumors-100615157","NCT07288957","A Early Study of ABSK131 in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients With MTAP-Deficient Advanced\u002FMetastatic Solid Tumors","ABSK131-101","Inclusion Criteria:\n\n* 1\\. Patients should understand, sign, and date the written informed consent form before screening.\n* 2\\. Male or female aged 18 years or older.\n* 3\\. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.\n* 4\\. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.\n* 5\\. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.\n* 6\\. Backfill cohorts and expansion cohorts: Patients with 1 of the following cancers and have received no more than 3 prior lines of therapy。1)NSCLC；2) Pancreatic cancer；3)Esophageal cancer；4)Gastric cancer；5)Mesotheliomas.\n\nFood effect: a. Be able to eat a standardized high-fat meal within 30 minutes. b. Without primary GI tumors or metastasis.\n\n* 7\\. Patients must have at least one measurable target lesion according to RECIST v1.1.\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 9\\. Life expectancy ≥3 months.\n* 10.Adequate organ function and bone marrow function as indicated by the screening assessments performed within 14 days prior to the first dose of study drug.\n* 11.Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose.\n* 12.Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control from signing the informed consent to approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to any component of ABSK131.\n* 2\\. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.\n* 3\\. Another active primary malignancy.\n* 4\\. Unable to swallow capsules 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, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.\n* 5\\. Any of the situation within the specified time frame prior to the first administration of study drug.\n* 6\\. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤ 1 severity (CTCAE v5.0) with the exception of which eligibility criteria allows, or alopecia, vitiligo, hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.\n* 7\\. Potent strong inhibitors or inducers of CYP3A family within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville oranges or juice products within 3 days prior to the first dose of study treatment.\n* 8\\. Proton pump inhibitors, such as omeprazole, lansoprazole, dexlansoprazole, or pantoprazole within 7 days before the first dose of study treatment.\n* 9\\. Imaging (CT or MRI) showed tumor invasion of large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or risk of bleeding (such as esophageal and gastric varices).\n* 10.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic) or symptomatic unstable brain metastases. Patients with a history of brain metastases have been treated and are stable ≥ 28 days may be enrolled. Patients with no steroid use for at least 2 weeks prior to the time of enrollment are permitted.\n* 11.Impaired cardiac function or clinically significant cardiac disease.\n* 12.Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1\u002F2 antibody.\n* 13.Exclusion of hepatitis infection.\n* 14.Patients with ascites or pleural effusion, or pericardial effusion which is refractory\u002Funcontrolled, or requiring the intervention within 2 weeks prior to the first dose.\n* 15.Confirmed or suspected ILD\u002Fpneumonitis or history of (non-infectious) ILD\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen.\n* 16.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.\n* 17.Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines .\n* 18.Has had an allogenic tissue\u002Fsolid organ transplant.\n* 19.Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n* 20.Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of investigators, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.",{"count":195,"type":20},266,[51],"This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced\u002FMetastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.",[199],"Solid Tumors (Phase 1)",[201,202,203],"ABSK131","MTAP","PRMT5","2025-12-04",{"date":155,"type":31},{"date":207,"type":31},"2025-07-22",{"date":35,"type":20},{"name":37,"class":38},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":218,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":232,"locationsCount":112},"100585007","phase-1-a-mass-balance-study-of-14cabsk011-100585007","NCT06896760","A Mass Balance Study of [14C]ABSK011","A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants","Inclusion Criteria:\n\n1. Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;\n2. Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;\n3. Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)\u002Fheight (m) \\^2;\n4. Participants must have regular defecation in the past three months;\n5. Male participants of childbearing potential must agree to use effective contraceptive methods during the study and within 6 months after administration of study drug . Male subjects must agree to not donate sperm during this period.\n\nExclusion Criteria:\n\n1. Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);\n2. Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen\u002Fantibody, treponema pallidum antibody (Syphilis) screening;\n3. The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);\n4. Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;\n5. Known history of allergy to any drug or food;\n6. Participants who have participated in drug trials within 3 months before dosing.\n7. Participants who have participated in this study or any other study related to ABSK011, and have previously exposed to ABSK011;\n8. Known history of drug abuse or tested positive in drug abuse screening;\n9. Participants with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.",true,"MALE","45 Years",{"count":221,"type":20},6,[51],"This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of \\[14C\\] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.",[225],"Healthy Subjects","2025-03-20",{"date":228,"type":31},"2025-03-26",{"date":230,"type":20},"2025-04-07",{"date":57,"type":20},{"name":37,"class":38},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":253},"100567431","phase-2-a-phase-2-clinical-study-of-combination-therapy-with-absk043-and-firmonertinib-100567431","NCT06668103","A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib","A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Firmonertinib in Patients With EGFR Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer(NSCLC)","Inclusion Criteria:\n\n1. Histologically or cytologically documented locally advanced or metastatic NSCLC\n2. At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n3. Inclusion Criteria Specific to Dose Escalation cohort and Dose Confirmation Cohort：Must has disease progression following treatment with EGFR-TKI in the locally advanced or metastatic setting for locally advanced or metastatic disease Documentation of PDL1 expression positive (TPS\u002FTC≥1%)detected from tumor tissue Inclusion Criteria Specific to Dose expansion Cohort： Must not have received any other prior systemic cancer therapies in the locally advanced\u002Fmetastatic setting PDL1 expression positive (TPS\u002FTC≥1%) as assessed by central laboratory from tumor tissue\n4. Adequate bone marrow reserve and organ function based on local laboratory data .\n5. Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA.\n\nExclusion Criteria:\n\n1. 1\\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.\n2. Has a history of interstitial lung disease (ILD)\u002Fpneumonitis or active ILD\n3. Has spinal cord compression or clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study\n4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline.\n5. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy.\n6. Uncontrolled or significant cardiovascular disease\n7. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.\n8. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study.",{"count":241,"type":20},54,[23],"This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.",[245],"Non-Small Cell Lung Cancer With EGFR Mutation","2024-12-09",{"date":248,"type":31},"2024-12-12",{"date":250,"type":31},"2024-11-25",{"date":136,"type":20},{"name":37,"class":38},5,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100564675","phase-2-a-phase-2-clinical-study-of-absk061-and-absk043-100564675","NCT06632262","A Phase 2 Clinical Study of ABSK061 and ABSK043","An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic\u002FUnresectable Solid Tumors with FGFR2\u002F3 Alterations","Inclusion Criteria:\n\n* Patients must have a measurable target lesion (per RECIST v1.1) (not applicable to expansion cohort 1) where:\n* Dose Escalation: patients with histologically confirmed solid tumors who have progressed after standard of care, are unable to tolerate standard therapy, or have no standard of care currently available:\n* Patients must have the a central laboratory or previous test report confirming FGFR2\u002F3 gene activatingon alterations (including FGFR2\u002F3 activating mutations, fusions\u002Frearrangements, or FGFR2 amplifications) or overexpression in tumor tissue or blood based on central laboratory test or previous test reports.\n* Expansion Phase:\n* Cohort 1 (HER2-gastric\u002Fgastroesophageal junction cancer)\n* Histologically or cytologically confirmed metastatic\u002Funresectable gastric\u002Fgastroesophageal junction cancer, HER2 test negative\n* The patient had FGFR2 amplification or overexpression in tumor tissue confirmed by a central laboratory test or a previous test report (previous test report only applied to FGFR2 amplification)\n* Patients need to provide prior tumor tissue or willingness to undergo biopsy if no prior tumor tissue or insufficient quantity is required\n* No prior (or up to one course of chemotherapy) systemic therapy for advanced gastric\u002Fgastroesophageal junction cancer, or disease progression more than 6 months after the end of the last prior adjuvant therapy\n* Patients must have a measurable target lesion or evaluable non-target lesion (per RECIST v1.1)\n* Cohort 2 (urothelial carcinoma)\n* Histologically or cytologically confirmed metastatic\u002Funresectable urothelial carcinoma with other histologic differentiation (including adenoid, squamous, or other types)\n* Patients must have the prespecified a central laboratory or previous test report confirming the presence of a specific FGFR3 mutation or overexpression, FGFR2\u002F3 fusion in tumor tissue or blood based on central laboratory test or previous test reports.\n* No prior (or up to one course of chemotherapy) systemic therapy for advanced urothelial carcinoma, or disease progression more than 12 months after the end of the last prior adjuvant therapy, or disease progression or intolerable toxicity after at least one line of standard of care (per local standard of care or guidelines)\n* Cohort 3 (non-small cell lung cancer)\n* Histologically or cytologically confirmed metastatic\u002Funresectable non-small cell lung cancer (NSCLC)\n* Patients must have the prespecified a central laboratory or previous test report confirming the presence of a specific FGFR2\u002F3 mutation, fusion, or overexpression in tumor tissue or blood based on central laboratory test or previous test reports.\n* Disease progression or intolerable toxicity after at least one prior line of standard of care or targeted therapy for driver mutations (according to local standards of care or guidelines)\n* Cohort 4 (Other Solid Tumors)\n* Histologically or cytologically confirmed metastatic\u002Funresectable other solid tumors\n* Patients must have a central laboratory or previous test report confirmingthe FGFR2\u002F3 gene activationng alterations (including FGFR2\u002F3 activating mutations, fusions\u002Frearrangements, or FGFR2 amplifications) or overexpression in tumor tissue or blood based on central laboratory test or previous test reports.\n* Disease progression or intolerable toxicity after at least one prior line of standard therapy.\n\nExclusion Criteria:\n\n* Previous treatment with an FGFR pathway inhibitor or a multi-kinase inhibitor designed to inhibit FGFR (consultation with the sponsor is recommended)\n* Active or medical history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Patients with type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.Uncertain autoimmune-related status should be discussed with the sponsor).\n* The patient had clinically symptomatic lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, severe radiation pneumonitis, etc.) requiring systemic corticosteroid therapy within 6 months prior to enrollment.\n* Known other malignancies that are in progression or require active treatment (except cured skin cancer, carcinoma in situ of the cervix, basal cell carcinoma, focal prostate cancer with a Gleason score of 6, focal prostate cancer with a Gleason score of 3 + 4 and treated for more than 6 months at screening).\n* Time from the end of other prior anti-tumor therapy to the first dose of study drug: major surgery (palliative treatment for local lesions is allowed), in vitro and in vivo radiotherapy (\\> 30% bone marrow exposure) is less than 4 weeks; received immunotherapy or other antibody study drugs within 4 weeks prior to the start of study treatment; received chemotherapy (within 6 weeks of the start of study treatment with nitrosourea or mitomycin chemotherapy), endocrine therapy, and small molecule targeted therapy within 2 weeks or 5 half-lives, whichever is shorter.\n* Patients who have not recovered to ≤ Grade 1 (CTCAE v5.0) from toxicities caused by prior chemotherapy, radiotherapy, and other anti-tumor therapies, including immunotherapy (except for alopecia as permitted by eligibility criteria or alopecia, vitiligo, stable hypothyroidism controlled by hormone replacement therapy, ≤ Grade 2 hearing loss, or ≤ Grade 2 peripheral neurotoxicity).\n* History of ≥ Grade 3 immune-related adverse events with prior therapy.\n* (Expansion Cohort 3 (non-small cell lung cancer)) Patients were previously identified with driver mutations (according to local diagnostic and therapeutic criteria or guidelines such as EGFR mutation, ALK rearrangement positive, KRAS G12C mutation positive, NTRK1\u002F2\u002F3 gene fusion positive, RET fusion positive, MET exon 14 skipping mutation, BRAF V600E mutation positive, ROS1 rearrangement positive) and did not receive targeted therapy.",{"count":262,"type":20},202,[23],"The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic\u002FUnresectable Solid Tumors with FGFR2\u002F3 Alterations",[266,267,26,268],"HER2-Gastric\u002FGastroesophageal Junction Cancer","Urothelial Carcinoma","Solid Tumors","2024-11-18",{"date":271,"type":31},"2024-11-19",{"date":273,"type":31},"2024-11-13",{"date":275,"type":20},"2030-06-30",{"name":37,"class":38},21,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100458048","phase-1-a-study-to-assess-safety-tolerability-and-pharmacokinetics-of-absk061-in-patients-with-advanced-solid-tumors-100458048","NCT05244551","A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors","A Phase 1, Open-Label Study of ABSK061 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patient should understand, sign, and date the written informed consent form prior to screening.\n2. Male or female age 18 years or older.\n3. For escalation part: patients with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.\n\nFor expansion Part:\n\n1. Patients with histologically confirmed urothelial carcinoma or cholangiocarcinoma who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.\n2. Patients must have tumors with following FGFR2\u002F3 genetic alterations based on central laboratory test or existing test reports: Urothelial carcinoma: FGFR2\u002F3 fusions and FGFR3 activating mutations Cholangiocarcinoma: FGFR2 fusions and\u002For arrangements\n3. Patients must have at least one measurable target lesion according to RECIST 1.1.\n4. Patients are willing to undergo biopsy if archival tumor tissue is not available or the archival specimen deemed inadequate or confirmed FGFR2\u002F3 alterations from existing reports is not available.\n\n4\\. ECOG performance status 0 or 1 5. Life expectancy ≥3 months 6. 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:\n\n1. Absolute neutrophil count (ANC) ≥1.5×109\u002FL\n2. Platelet count (PLT) ≥ 100×109\u002FL without transfusion requirement within 14 days before 1st dose\n3. Hemoglobin (Hb)≥90 g\u002FL\n4. Total bilirubin (TBIL) ≤1×ULN\n5. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN.\n6. Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥ 50 mL\u002Fmin based on Cockcroft-Gault formula\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the investigational product\n2. For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)\n3. Has a known additional malignancy that is progressing or has required active treatment.\n4. Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication\n5. Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy or other investigational drugs received ≤4 weeks; endocrine therapy ≤2 weeks or ≤5-half life (whichever is shorter) 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) with the exception of alopecia and vitiligo.\n8. Concomitant use of the drugs\u002Fremedies that may cause pharmacokinetic drug-drug interactions; consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice products within 7 days prior to the first dose of study medication.\n9. Active central nervous system (CNS) metastases including presence of cerebral edema, requirement for systemic steroid treatment, disease progression due to intracranial lesions, leptomeningeal metastasis, and other clinical symptoms related to CNS metastases.\n10. Impaired cardiac function or clinically significant cardiac disease, including any one of the following:\n\n    * New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure\n    * Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF \\>470 ms or history of long QT interval corrected (QTc) syndrome (Note: QTc interval corrected by Fridericia's formula).\n    * Left ventricular ejection fraction (LVEF) \\\u003C50% or below the institutional lower limit of normal (whichever is higher)\n11. Known human immunodeficiency virus (HIV) or active hepatitis B, or active hepatitis C infection; positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to hepatitis B core Ag (HBcAb), or hepatitis C RNA in serum (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test are allowed; positive tests for HBV HBsAg or HBcAb with HBV-DNA measurements lower than 1000IU\u002Fml can be included)\n12. Any of the following ophthalmological criteria:\n\n    * Current evidence or previous history of retinal pigmented epithelial detachment (RPED)\n    * Previous laser treatment or intra-ocular injection for treatment of macular degeneration\n    * Current evidence or previous history of dry or wet age-related macular degeneration\n    * Current evidence or previous history of retinal vein occlusion (RVO)\n    * Current evidence or previous history of retinal degenerative diseases (eg, hereditary)\n    * Current evidence or previous history of any other clinically relevant chorioretinal defect\n    * Current evidence or previous history of corneal pathology such as conjunctivitis, keratopathy, corneal abrasion or ulceration\n13. Patients with refractory\u002Funcontrolled ascites or pleural effusion.\n14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.\n15. Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study and for up to 6 months after the last dose of study drug.\n16. Sexually active males, unless they use a condom during intercourse while taking drug and for 5 consecutive compound half-lives plus 60 days after stopping study drug, should not father a child. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid.\n17. Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).\n18. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.",{"count":286,"type":20},85,[51],"This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.",[290],"Solid Tumor","2024-08-08",{"date":293,"type":31},"2024-08-12",{"date":295,"type":31},"2022-06-30",{"date":297,"type":20},"2025-04-30",{"name":37,"class":38},22,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":253},"100524633","phase-2-a-phase-2-study-of-absk021-in-patients-with-advanced-pancreatic-cancer-100524633","NCT06111274","A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer","A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Male and female aged 18-75 years old. The subjects must have informed consent to the study, and signed the written informed consent voluntarily.\n* Diagnosis as non resectable local advanced or metastatic pancreatic cancer by histology or cytology.\n* Measurable disease as defined by RECIST 1.1.\n* Without systemic treatment for pancreatic cancer.\n* ECOG physical strength score 0-2\n* Estimated survival time \\>=3 months.\n* The adequate bone marrow fuction and coagulation function\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any components of the investigational drug product.\n* Previous treatment with highly selective inhibitors targeting Colony Stimulating Factor 1 (CSF-1)\u002FColony Stimulating Factor 1 Receptor (CSF-1R).\n* With Breast Cancer Gene 1\u002F2 (BRCA1\u002F2) gene mutation.\n* With a history of other malignancies within 5 years.\n* During the trial, other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or traditional Chinese medicine must be used for anti-tumor treatment.\n* With conditions that significantly affected the absorption of oral drug.\n* Surgical treatment is required within 4 weeks before the first administration, or unhealed, infected, or dehiscence of previous surgical wounds.\n* During the 2 weeks prior to the first administration of this study, the patient was receiving chronic systemic steroid treatment or any other form of immunosuppressive treatment.\n* Concomitant use of strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 14 days prior to randomization.\n* Previous peripheral neuropathy \\> grade 1 (Common Terminology Criteria for Adverse Events, version 5.0).\n* Diagnosed with immune deficiency or interstitial lung disease.\n* The patients were vaccinated within 4 weeks before the first treatment.\n* Participated in any drug clinical trial within 4 weeks before the first treatment.\n* Active central nervous system (CNS) metastases.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.\n* Known active infections from certain viruses, bacteria or parasites.\n* Patients with refractory\u002Funcontrolled ascites or pleural effusion.\n* Pregnant or lactating women.\n* Any other clinically significant comorbidities, which in the judgment of the Investigator, should not be included.",{"count":308,"type":20},82,[23],"The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer. The main questions it aims to answer are:\n\n* Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is safe in patients with advanced pancreatic cancer.\n* Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is effective in patients with advanced pancreatic cancer.\n\nParticipants will be asked to complete the study procedures:\n\n* Receive the administration of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab about 24 weeks in study Part A or Part B.\n* Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2.\n* Complete the study procedures specified in the protocol, which is guided by researchers.",[312],"Advanced Pancreatic Cancer","2024-04-10",{"date":315,"type":31},"2024-04-11",{"date":317,"type":31},"2023-10-17",{"date":319,"type":20},"2026-12-29",{"name":37,"class":38},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":5},"100533437","phase-1-a-study-to-assess-safety-tolerability-and-pharmacokinetics-of-absk112-in-patients-with-non-small-cell-lung-cancer-100533437","NCT06225804","A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer","A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients should understand, sign, and date the written informed consent form prior to screening.\n2. Male or female aged 18 years or older.\n3. Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.\n4. Cohort-specific inclusion criteria:\n\n   1. For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists\n   2. For RDE confirmation in the escalation part: same as Cohort 1 in the expansion part\n   3. For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories; and must also meet all criteria for the cohort in which their entry is proposed.\n5. Patients must have at least one measurable target lesion according to RECIST v1.1\n6. ECOG performance status 0 or 1\n7. 7\\. Life expectancy ≥3 months\n8. Adequate organ function and bone marrow function.\n9. Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol\u002FL, potassium within institutional normal limits\n10. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle1 Day1.\n11. For patients participating in food effect exploration part:\n\n    1. Be able to eat a standardized high-fat meal within 30 minutes\n    2. Be able to fast for 10 hours.\n12. Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study treatment and for approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to any component of the investigational product.\n2. NSCLC patients with EGFR Cys797Ser (C797S) mutation.\n3. Cohort-specific exclusion criteria.\n4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n5. Unable to swallow capsules 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, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.\n6. Previous anti-cancer therapy, including chemotherapy, radiotherapy, molecular targeted therapy, antibody therapy or other investigational drugs received ≤4 weeks prior to initiation of study treatment.\n7. Major surgery within 4 weeks prior to the first dose of study drug. Or any surgical wound is infected, dehisced, or not completely healed before the screening.\n8. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0) with the exception of which eligibility criteria allows, or alopecia, vitiligo, hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.\n\n   Note: Refer to inclusion criteria regarding hypertension.\n9. Potent moderate and strong inhibitors or inducers of CYP3A family within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville oranges or juice products within 3 days prior to the first dose of study treatment.\n10. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).\n11. Impaired cardiac function or clinically significant cardiac disease.\n12. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1\u002F2 antibody.\n13. Exclusion of hepatitis infection based on the following results and\u002For criteria:\n\n    1. Active hepatitis B infection: positive tests for hepatitis B surface antigen (HbsAg), or antibody to hepatitis B core antigen (anti-HBc). A patient with positive tests for HbsAg or anti-HBc but with HBV-DNA measurements lower than detectable can be enrolled.\n    2. Active hepatitis C infection: positive Hepatitis C virus antibody. If positive antibody to hepatitis C Virus (anti-HCV) is detected, Hepatitis C virus RNA by polymerase chain reaction (PCR) is necessary. A patient with positive anti-HCV but with a negative test for HCV RNA can be enrolled.\n14. Patients with ascites or pleural effusion, or pericardial effusion which is refractory\u002Funcontrolled, or requiring the intervention within 2 weeks prior to the first dose.\n15. Current evidence of radiation pneumonitis that required steroid treatment or unresolved drug-related pneumonitis, or current evidence or history of interstitial lung disease (ILD).\n16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.\n17. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).\n18. Current evidence or previous history of corneal pathology such as keratopathy, corneal abrasion or ulceration, or any other abnormal changes that may increase the risk of corneal toxicity during the study treatment\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of investigators, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.\n20. Planned major surgery during study treatment.",{"count":329,"type":20},164,[51],"This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.",[26],"2024-03-15",{"date":335,"type":31},"2024-03-18",{"date":337,"type":31},"2024-02-22",{"date":339,"type":20},"2028-03",{"name":37,"class":38},""]