[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Genfleet Therapeutics (Shanghai) Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":260},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,70,97,122,145,166,191,214,239],{"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":13,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100645104","phase-1-a-study-of-gfh276-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-and-pancreatic-ductal-adenocarcinoma-pdac-harboring-ras-mutation-100645104",false,"NCT07678593","A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","A Multi-center, Open-label Phase Ib\u002FII Study Exploring the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification\n3. At least one measurable lesion according to RECIST v1.1\n4. ECOG performance status 0 or 1\n5. Life expectancy \\> 3 months\n6. Adequate organ function\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.\n5. With active infection (HIV, HBV, HCV, syphilis)\n6. The presence of clinical or radiological evidence of intestinal obstruction.\n7. Prior anticancer therapy within 28 days or 5 half-lives\n8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months\n9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n10. History of central nervous system (CNS)disease\n11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.","ALL","18 Years",{"count":19,"type":20},222,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2",[26,27,28],"Advanced Solid Tumors Cancer","Pancreatic Ductal Adenocarcinoma","RAS Mutation",[30,31,28,32],"GFH276","PDAC","solid tumors","NOT_YET_RECRUITING","2026-06-24",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":20},"2026-09",{"date":41,"type":20},"2028-09",{"name":43,"class":44},"Genfleet Therapeutics (Shanghai) Inc.","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100613129","phase-3-phase-iii-study-to-compare-gfh375-and-chemotherapy-in-patients-with-kras-g12d-mutant-metastatic-pancreatic-cancer-100613129","NCT07262567","Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety\u002FTolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.\n* Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.\n* Have received at least one prior standard systemic therapy.\n* Participants must have at least one measurable lesion (per RECIST 1.1 criteria).\n* Expected survival time ≥ 12 weeks as judged by the investigator.\n* Have adequate organ function\n\nExclusion Criteria:\n\n* Other malignant tumors that progressed or required treatment within 3 years prior to randomization.\n* With active central nervous system (CNS) metastasis.\n* Previous receipt of therapy targeted for KRAS G12D or pan-RAS\u002FKRAS.\n* Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.\n* Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.\n* With clinically significant severe cardiovascular diseases.\n* Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.\n* Complicated with major acute or chronic infectious diseases.\n* Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.\n* Pregnant or lactating females.\n* Other conditions deemed inappropriate for participation in the study by the investigator.","80 Years",{"count":55,"type":20},320,[57],"PHASE3","This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.",[60],"Metastatic Pancreatic Cancer","RECRUITING",{"date":63,"type":37},"2026-06-26",{"date":65,"type":37},"2025-12-04",{"date":67,"type":20},"2028-06",{"name":43,"class":44},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":69},"100643968","phase-3-a-study-to-evaluate-gfh375-versus-docetaxel-in-participants-with-non-small-cell-lung-cancer-with-kras-g12d-mutation-100643968","NCT07668752","A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation","A Phase III, Randomized, Open-Label, Multicenter Study to Evaluate GFH375 Versus Docetaxel in Participants With Locally Advanced and Unresectable or Metastatic Non-Small Cell Lung Cancer With KRAS G12D Mutation Failed Prior Standard Therapy","Inclusion Criteria:\n\n* 1\\. Voluntary participation in the study and signed informed consent form (ICF).\n* 2\\. Age ≥ 18 years at the time of signing the ICF; male or female.\n* 3\\. Histologically or cytologically confirmed locally advanced unresectable or metastatic non small cell lung cancer (NSCLC).\n* 4\\. Participants must provide adequate and qualified tumor tissue slides samples or agree to undergo tumor biopsy to obtain tissue samples for central laboratory confirmation of KRAS G12D mutation.\n* 5\\. Disease progression or intolerance to toxicity after at least one prior line of platinum based chemotherapy and anti PD 1\u002FPD L1 antibody therapy.\n* 6\\. At least one measurable target lesion according to RECIST version 1.1.\n* 7\\. Investigator assessed life expectancy ≥ 12 weeks.\n* 8\\. Adequate organ function.\n* 9\\. Ability to communicate well, comply with scheduled follow up visits, and adhere to protocol requirements.\n\nExclusion Criteria:\n\n* 1\\. Presence of other driver gene mutations in NSCLC, or concurrent other KRAS or RAS mutations.\n* 2\\. Other malignancy that has progressed or required treatment within 3 years prior to randomization.\n* 3\\. Leptomeningeal metastasis, or symptomatic or progressive central nervous system (CNS) metastasis.\n* 4\\. Existing or potential severe bone injury due to bone metastasis, or uncontrolled pain related to bone metastasis.\n* 5\\. Prior treatment with KRAS G12D targeted therapy or pan RAS\u002FKRAS targeted therapy.\n* 6\\. Prior treatment with docetaxel as part of systemic therapy.\n* 7\\. Radiotherapy within 4 weeks prior to randomization, or other local anti tumor therapy within 4 weeks prior to randomization.\n* 8\\. Other anti tumor therapy within 28 days or 5 half lives prior to randomization, or cell therapy within 3 months prior to randomization.\n* 9\\. Clinically significant severe cardiovascular disease.\n* 10\\. Stroke or other severe cerebrovascular disease within 6 months prior to randomization.\n* 11\\. Major acute or chronic infectious disease.\n* 12\\. Other poorly controlled systemic diseases.\n* 13\\. Severe psychiatric or psychological disorder, or history of drug abuse, or severe alcohol abuse.\n* 14\\. Pregnancy or breastfeeding.\n* 15\\. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":78,"type":20},300,[57],"The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC).\n\nGFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC.\n\nThis is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives.\n\nAfter enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel.\n\n* GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days.\n* Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg\u002Fm² once every 3 weeks.\n\nStudy treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment.\n\nSome participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.",[82,83],"KRAS G12D Mutation","NSCLC (Non-small Cell Lung Cancer)",[85,86,87,88],"GFH375","Docetaxel","Non-small cell lung cancer (NSCLC)","KRAS G12D","2026-06-23",{"date":91,"type":37},"2026-06-25",{"date":93,"type":20},"2026-07-15",{"date":95,"type":20},"2031-04-30",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100635605","phase-2-gfh375-monotherapy-and-combination-therapy-as-first-line-treatment-for-advanced-kras-g12d-mutant-non-small-cell-lung-cancer-100635605","NCT07554859","GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer","A Multicenter, Open-label, Randomized Clinical Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of GFH375 Monotherapy and Combination Therapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer Harboring KRAS G12D Mutation.","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign the written informed consent form.\n2. Male or female, aged 18 to 75 years at the time of signing the informed consent form.\n3. Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that is not amenable to radical surgery or radiotherapy.\n4. Have a written report confirming KRAS G12D mutation positive.\n5. Able to provide an archival tumor tissue sample \\[formalin-fixed, paraffin-embedded (FFPE) block or unstained FFPE tumor sections\\] or to undergo a tumor biopsy prior to treatment.\n6. No prior systemic anti-tumor therapy for advanced disease; or not eligible for standard of care therapy; or in the investigator's judgment, may benefit more from GFH375 monotherapy or combination therapy than from available standard therapy.\n7. Have at least one measurable lesion outside the central nervous system (CNS) per RECIST v1.1. Lesions that have received prior local radiotherapy can be considered measurable only if they have demonstrated clear progression after radiotherapy; otherwise, they are not considered measurable.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n\n9.Life expectancy of at least 3 months as assessed by the investigator. 10.Adequate organ function.\n\nExclusion Criteria:\n\n1. Has had another invasive malignancy that progressed or required treatment within 3 years prior to randomization, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, squamous cell carcinoma in situ, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.\n2. Pathologically (histologically or cytologically) confirmed squamous cell lung cancer, adenosquamous carcinoma, neuroendocrine carcinoma (including small cell lung cancer and large cell neuroendocrine carcinoma), or mixed small cell lung cancer.\n3. Known to harbor other targetable driver gene alterations.\n4. Has active or symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression.\n5. Has clinically significant severe cardiovascular disease.\n6. Has had a stroke or other serious cerebrovascular event within 6 months prior to randomization.\n7. Has a history of deep vein thrombosis or other severe thromboembolism within 3 months prior to randomization.\n8. Has pleural effusion, ascites, or pericardial effusion requiring frequent drainage (≥2 times per month) or associated with moderate to severe symptoms.\n9. Has clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.\n10. At high risk of gastrointestinal bleeding or perforation.\n11. Has pyloric obstruction, persistent or recurrent vomiting (≥3 episodes within 24 hours); is unable or unwilling to swallow tablets; or has other impaired gastrointestinal function or gastrointestinal disease that may significantly affect the absorption of GFH375.\n12. History of chronic diarrhea.\n13. Has a major acute or chronic infectious disease.\n14. Has other uncontrolled systemic medical conditions.\n15. Planned major surgery as determined by the investigator.\n16. History of organ transplantation or preparing to undergo organ transplantation (except corneal transplantation).\n17. Known allergy to the investigational drug or its components.\n18. Received or planned to receive a live attenuated vaccine within 28 days prior to randomization or during the administration of the investigational drug.\n19. Having severe mental or psychological disorders, a history of substance abuse, or a history of severe alcoholism.\n20. Pregnant or breastfeeding women.\n21. Other conditions deemed by the investigator to be inappropriate for participation in the study.","75 Years",{"count":106,"type":20},90,[24],"This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).Every cohort will recruit 30 participants.",[110],"NSCLC (Advanced Non-small Cell Lung Cancer)",[112],"KRAS G12D Mutations","2026-04-21",{"date":115,"type":37},"2026-04-28",{"date":117,"type":20},"2026-05-20",{"date":119,"type":20},"2028-04-30",{"name":43,"class":44},2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100612900","phase-1-a-study-of-gfh375-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-harboring-kras-g12d-mutation-100612900","NCT07259590","A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation","A Multicenter, Open-Label, Phase Ib\u002FII Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety\u002FTolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form.\n2. Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.\n3. Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.\n4. Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.\n5. At least one measurable lesions according to RECIST v1.1\n6. Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.\n7. Have sufficient organ function.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.\n2. Presence of known coexisting other cancer driver genes.\n3. Previous or active history of clinically significant cardiovascular dysfunction.\n4. Presence of active infection.\n5. History of central nervous system (CNS) diseases.\n6. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.\n7. Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.\n8. Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.\n9. Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.\n10. Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.",{"count":130,"type":20},126,[23,24],"This is a Phase Ib\u002FII clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety\u002Ftolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety\u002Ftolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.",[26,31,134],"CRC (Colorectal Cancer)",[32,112],"2025-11-20",{"date":138,"type":37},"2025-12-02",{"date":140,"type":37},"2025-10-21",{"date":142,"type":20},"2027-07",{"name":43,"class":44},4,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},"100554560","phase-1-a-study-of-gfh375-in-patients-with-advanced-solid-tumors-with-kras-g12d-mutations-100554560","NCT06500676","A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations","An Open-Label, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n2. Male or female ≥ 18 years old and ≤75 years old.\n3. ECOG performance status of 0-1.\n4. With a life expectancy of ≥12 weeks.\n5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.\n6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.\n7. Adequate laboratory parameters during the screening period.\n\nExclusion Criteria:\n\n1. Active brain metastases.\n2. Prior treatment with a KRAS G12D inhibitor.\n3. Palliative radiotherapy was completed within 14 days before the first dose.\n4. Have poorly controlled or severe cardiovascular disease.\n5. Subjects with active hepatitis B or active hepatitis C.\n6. Known allergy to the study drug or its components.\n7. Pregnant or lactating women.",{"count":153,"type":20},407,[23,24],"This is a multicenter, open-label, phase I\u002FII study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.",[112,157],"Advanced Solid Tumors","2025-11-17",{"date":136,"type":37},{"date":161,"type":37},"2024-07-09",{"date":163,"type":20},"2028-12-31",{"name":43,"class":44},20,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":69},"100608189","phase-1-a-single-arm-open-label-multicenter-phase-iii-clinical-study-of-gfh276-in-patients-with-ras-mutant-advanced-solid-tumors-100608189","NCT07198321","A Single-Arm, Open-Label, Multicenter Phase I\u002FII Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors","A Single-Arm, Open-Label, Multicenter Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n2. Male or female ≥ 18 years old and ≤75 years old.\n3. ECOG performance status of 0-1.\n4. With a life expectancy of ≥3 moths\n5. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.\n6. Adequate laboratory parameters during the screening period.\n\nExclusion Criteria:\n\n1. Active brain metastases.\n2. Prior treatment with a PAN-RAS inhibitor.\n3. Palliative radiotherapy was completed within 14 days before the first dose.\n4. Have poorly controlled or severe cardiovascular disease.\n5. Subjects with active hepatitis B or active hepatitis C.\n6. Known allergy to the study drug or its components.\n7. Pregnant or lactating women.",{"count":174,"type":20},450,[23,24],"This study is an investigation to evaluate the safety\u002Ftolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations.\n\nThe primary objectives of the Phase I study are to assess the safety\u002Ftolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276.\n\nThe primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.",[178,31,134,179],"Cancer","NSCLC",[181,182],"cancer","RAS","2025-09-25",{"date":185,"type":37},"2025-09-30",{"date":187,"type":20},"2025-09-22",{"date":189,"type":20},"2027-12-30",{"name":43,"class":44},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":121},"100544964","phase-1-a-study-of-gfh009-in-combination-with-zanubrutinib-in-subjects-with-relapsed-or-refractory-dlbcl-100544964","NCT06375733","A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL","A Phase Ib\u002FII, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including: DLBCL, not specified (NOS), T-cell\u002Fhistiocyte-rich large B-cell lymphoma (THRLBCL), high-grade B-cell lymphoma, or large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to Richter syndrome, transformed follicular lymphoma, transformed MZL) (2016 WHO classification).\n3. Relapse or refractory after receiving 2\\~4 systemic treatment regimens, at least one of which contains anthracyclines and Rituximab.\n4. Must have a measurable lesion.\n5. The patient is not suitable to receive stem cell transplantation judged by the investigator.\n6. The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) is 0\\~2.\n7. Have adequate organ function, including:\n\n   i. Hematopoietic function: absolute neutrophil count (ANC) ≥1.0×109\u002FL, platelet count (PLT) ≥75×109\u002FL and hemoglobin (Hgb) ≥ 80 g\u002FL.\n\nii. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n\niii. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or serum creatinine clearance ≥ 50 mL\u002Fmin when Cr \\> 1.5× ULN.\n\niv. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n1. Primary or secondary central nervous system (CNS) lymphoma.\n2. Received chemotherapy, targeted therapy, endocrine therapy, immunotherapy, Chinese patent medicine with anti-tumor effect and other investigational drugs or device therapy within 28 days or 5 half-lives (whichever is shorter), or received therapeutic or palliative radiotherapy within 14 days, or received CAR-T therapy within 12 weeks prior to the administration of the study drugs.\n3. Patients with primary resistance to CDK9 or BTK inhibitors.\n4. Has a history of organ transplantation or allogeneic stem cell transplantation. Patients who have undergone autologous stem cell transplantation within 6 months.\n5. Other malignancies within 2 years prior to study entry, excluding appropriately treated carcinoma in situ of the cervix, focal squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle-invasive urothelial carcinoma.\n6. Have significant diseases of the cardiovascular system or significant acute or chronic infection. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. Presence of significant gastrointestinal disorders. Current clinically significant interstitial lung disease, radiation pneumonitis, or drug-associated pneumonia requiring treatment. Accompanied by other poorly controlled systemic diseases, such as hypertension, diabetes mellitus, etc.\n7. Has a history of bleeding disorder or a history of spontaneous bleeding requiring blood transfusion or other medical intervention. Active bleeding within 2 months prior to the first dose.\n8. Surgical procedures (excluding needle biopsies) that may affect the administration or study evaluation of this study within 28 days prior to the first dose.\n9. Patients who have been treated with prednisone (or equivalent doses of glucocorticoids) at \\>20 mg\u002Fday for anti-tumor purposes within 7 days, or who require long-term use of glucocorticoids for non-anti-tumor therapy.\n10. Ongoing medical treatment with a potent inhibitor or inducer of CYP3A is required.",{"count":199,"type":20},51,[23,24],"This is a multicentre, open-label phase Ib\u002FII study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)",[203],"Large B-cell Lymphoma",[205],"relapsed or refractory diffuse large B-cell lymphoma (DLBCL)","2025-08-11",{"date":208,"type":37},"2025-08-12",{"date":210,"type":37},"2024-03-20",{"date":212,"type":20},"2026-12-31",{"name":43,"class":44},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":69},"100585122","phase-1-a-phase-i-study-to-evaluate-gfs202a-in-advanced-solid-tumor-patients-with-pre-cachexia-or-cachexia-100585122","NCT06898255","A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia","An Open-label, Multi-center, Phase I Study to Evaluate the Safety\u002FTolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form.\n2. Men or women between the ages of 18 and 80 years at the time of written informed consent.\n3. Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI \\\u003C 21 kg\u002Fm2 within 6 months before the first study dose.\n4. Persistent concomitant appetite\u002Feating problems related to cancer.\n5. It has adequate organ function.\n6. The ECOG PS score was 0-2.\n7. The investigator judged the expected survival time to be ≥ 3 months.\n\nExclusion Criteria:\n\n1. With active brain metastases.\n2. With other active diseases that lead to reduced food intake or seriously affect digestion and absorption\n3. Baseline BMI \\> 28 kg\u002Fm2.\n4. With infectious diseases.\n5. With clinically significant cardiovascular disease.\n6. With uncontrolled metabolic diseases.\n7. With known clinically significant allergic reactions to antibodies and excipients.\n8. With history of drug or alcohol abuse.\n9. Pregnant or lactating female subjects or women planning to become pregnant during the study.\n10. With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time\u002Fmonth).\n11. Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.",{"count":222,"type":20},36,[23],"An open-label, multi-center, phase I study to evaluate the safety\u002Ftolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety\u002Ftolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.\n\nEnroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) \u002Fbiomarker samples will be collected.",[226],"Cancer Cachexia",[228,181,229,230],"cachexia","GDF-15","IL-6","2025-06-03",{"date":233,"type":37},"2025-06-05",{"date":235,"type":37},"2025-04-24",{"date":237,"type":20},"2026-07-06",{"name":43,"class":44},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":69},"100511059","phase-1-a-study-of-gfh009-monotherapy-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl-100511059","NCT05934513","A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","A Phase Ib\u002FII, Multicentre, Open-label Study to Assess the Efficacy, Safety\u002F Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Inclusion Criteria:\n\n1. Male or female ≥ 18 years and ≤ 75 years.\n2. Written informed consent must be obtained prior to any screening procedures.\n3. Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.\n4. Must have received and failed at least 2 but no more than 5 prior lines of therapies .\n5. Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).\n6. Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.\n7. Eastern Cooperative Oncology Group performance status of ≤ 2.\n8. Adequate haematologic and organ function at screening.\n9. Life expectancy ≥ 12 week.\n10. Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and \\\u003C Grade 2 sensory neuropathy.\n11. For women of childbearing potential, she must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug. Men with a partner of childbearing potential, must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug\n\nExclusion Criteria:\n\n1. Diagnosis of Cutaneous T-cell lymphoma .\n2. Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.\n3. Patients with severe hemophagocytic syndrome at screening.\n4. Presence of uncontrolled third space effusion\n5. Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or undergone major surgery with 4 weeks; or received targeted therapy within 4 weeks or 5 half-lives whichever is shorter; or received immunotherapy.\n6. History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.\n7. Attend other clinical trial within 2 weeks prior to starting study drug.\n8. History of previous exposure to any other CDK9 inhibitor.\n9. Concurrent malignancy within 5 years prior to entry\n10. Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.\n11. Severe cardiovascular disease\n12. Subjects with high risk of gastrointestinal hemorrhage.\n13. Uncontrolled infective diseases.\n14. Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day and the duration of treatment was more than 14 days.\n15. Concomitant medications that are strong CYP3A4 inhibitors or strong inducers within 7 days prior to the first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pomelos, star citrus fruits or St. John's wort within 7 days of first dose.\n16. Major surgery within 4 weeks prior to study entry or surgery is under schedule in the short run.\n17. Pregnant or breast-feeding female.\n18. Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.",{"count":247,"type":20},95,[23,24],"This is a multicentre, open-label phase Ib\u002FII study. The purpose of the study is to assess the efficacy, safety\u002F tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma",[251],"Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","2024-12-10",{"date":254,"type":37},"2024-12-13",{"date":256,"type":37},"2023-09-06",{"date":258,"type":20},"2026-06-30",{"name":43,"class":44},""]