[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dizal Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":296},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,40,63,84,104,126,147,169,191,213,235,258,277],{"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},"100604803","phase-2-a-study-of-dzd8586-combination-in-cllsll-tai-shan10-100604803",false,"NCT07154264","A Study of DZD8586 Combination in CLL\u002FSLL (TAI-SHAN10)","A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL\u002FSLL)","Inclusion Criteria:\n\n1. Male and female ≥ 18 years of age.\n2. ECOG performance status 0-2, and life expectancy ≥ 6 months.\n3. Confirmed newly diagnosis or treatment naïve CLL\u002FSLL with indication for treatment.\n4. Patients with SLL must have at least one measurable lesion.\n5. Adequate bone marrow reserve and organ functions.\n6. Willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n1. Any of previous or current treatment prohibited by protocol.\n2. Any unresolved \\> grade 1 drug-related adverse events.\n3. Known or suspected Richter's transformation, or prolymphocytic leukemia.\n4. CNS involvement.\n5. Active infection.\n6. Any of severe cardiac or pulmonary abnormalities.\n7. Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.\n8. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.\n9. Prior malignancy within the past 3 years.\n10. Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL\u002FSLL.\n\nThis study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.",[26],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","RECRUITING","2026-06-18",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":31},"2025-09-22",{"date":35,"type":20},"2030-01",{"name":37,"class":38},"Dizal Pharmaceuticals","INDUSTRY",15,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100610944","phase-3-a-phase-3-multinational-study-of-golidocitinib-versus-investigators-choice-in-rr-ptcl-jackpot19-100610944","NCT07234162","A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r\u002Fr PTCL (JACKPOT19)","A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol\n* Age ≥ 18 years\n* ECOG 0-2 score, life expectancy ≥ 12 weeks\n* Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer\u002FT-cell lymphoma (NK\u002FTCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL)\n* Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator\n* Adequate bone marrow reserve and organ system functions\n* Willing to comply with contraceptive restrictions\n\nExclusion Criteria:\n\n* Any of previous or current treatment prohibited by protocol\n* Any unresolved \\> grade 2 drug-related adverse events\n* Lymphoma involving central nervous system\n* Any of severe cardiac or pulmonary abnormalities\n* Disease condition requires immunosuppressants, biologics, or NSAIDs\n* Active infection\n* Malignancy disease within five years\n* Poorly controlled gastrointestinal disorder or inadequate absorption of medication\n* Severe or poorly controlled systemic diseases",{"count":48,"type":20},218,[50],"PHASE3","This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed\u002Frefractory peripheral T-cell lymphoma (r\u002Fr PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory\u002Fintolerant to at least one prior systemic treatment regimen(s).",[53],"Peripheral T-cell Lymphoma","2026-06-04",{"date":56,"type":31},"2026-06-08",{"date":58,"type":31},"2024-05-13",{"date":60,"type":20},"2028-10-31",{"name":37,"class":38},51,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100603696","phase-3-a-study-of-dzd8586-versus-investigators-choice-in-rr-cllsll-tai-shan6-100603696","NCT07139873","A Study of DZD8586 Versus Investigator's Choice in r\u002Fr CLL\u002FSLL (TAI-SHAN6)","A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age.\n2. ECOG performance status 0-2.\n3. Confirmed diagnosis of relapsed or refractory CLL\u002FSLL with indication for treatment.\n4. Adequate bone marrow reserve and organ system functions.\n5. Participants willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n1. Any unresolved \\> Grade 1 adverse event at the time of starting study treatment.\n2. Known or suspected Richter transformation.\n3. Known or suspected CNS involvement.\n4. Previous or current therapy and comedications meet exclusion criteria.\n5. Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.\n6. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.\n7. Women who are breast feeding.\n8. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.",{"count":71,"type":20},250,[50],"This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma who have progressed following prior therapy.\n\nPrimary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.",[26],"2026-05-31",{"date":77,"type":31},"2026-06-03",{"date":79,"type":31},"2025-09-08",{"date":81,"type":20},"2029-12",{"name":37,"class":38},2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100557520","phase-2-dzd8586-in-patients-with-relapsed-or-refractory-cllsll-tai-shan8-100557520","NCT06539182","DZD8586 in Patients With Relapsed or Refractory CLL\u002FSLL (TAI-SHAN8)","A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\nParticipants who meet all the following criteria:\n\n1. Male and female ≥ 18 years of age.\n2. ECOG performance status 0-2.\n3. Confirmed diagnosis of CLL\u002FSLL with indication for treatment.\n4. Adequate bone marrow reserve and organ system functions.\n5. Willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria:\n\n1. CNS involvement or Richter transformation.\n2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.\n3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.\n4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.\n5. Active infection.\n6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.\n7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.\n8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.\n9. Women who are breast feeding.\n10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.",{"count":92,"type":20},155,[23],"This study will treat patients with CLL\u002FSLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.",[26],{"date":97,"type":31},"2026-06-02",{"date":99,"type":31},"2024-04-29",{"date":101,"type":20},"2028-03",{"name":37,"class":38},17,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":125},"100631096","phase-1-assessing-treatment-of-t-cell-lymphoma-with-gw5282-in-combination-with-golidocitinib-bei-dou3-100631096","NCT07496229","Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)","A Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma","Inclusion Criteria:\n\n1. Signed informed consent;\n2. Adult ≥ 18 years of age;\n3. ECOG performance status score ≤ 2;\n4. Life expectancy of not less than 12 weeks;\n5. Histopathologically confirmed diagnosis of PTCL;\n6. Presence of measurable disease;\n7. Adequate bone marrow function and vital organ function reserve;\n8. Ability to comply with study requirements and to complete study-related procedures;\n9. Adequate contraception during participation in the trial.\n\nExclusion Criteria:\n\n1. Presence of unresolved drug-related adverse events greater than Grade 1;\n2. Lymphoma involving the central nervous system;\n3. Failure to complete the required washout period for other anti-tumor therapies;\n4. Corticosteroid use that does not meet protocol requirements;\n5. Major surgery\u002Ftrauma within a short period, or planned major surgery within a short period;\n6. Vaccination with a live vaccine within a short period;\n7. Inability to discontinue prohibited medications;\n8. Requirement for immunosuppressive agents or biologics due to an underlying disease;\n9. Presence of active infection;\n10. Significant cardiovascular disease;\n11. Presence of gastrointestinal disease that might affect drug intake or absorption;\n12. History of other malignancies;\n13. Known allergy to the study drug;\n14. Other severe or uncontrolled systemic diseases;\n15. Personnel with a conflict of interest (e.g., site staff, sponsor employees);\n16. Pregnant or breastfeeding women;\n17. Inability to comply with protocol requirements.",{"count":112,"type":20},165,[114,23],"PHASE1","This is a phase 1\u002F2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.",[117],"T-cell Lymphomas","2026-04-16",{"date":120,"type":31},"2026-04-17",{"date":122,"type":31},"2026-04-15",{"date":81,"type":20},{"name":37,"class":38},12,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":5},"100597527","phase-1-dzd8586-combination-therapy-in-patients-with-diffuse-large-b-cell-lymphoma-tai-shan12-100597527","NCT07059650","DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)","A Phase Ib\u002FII, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Cohort 1:\n\n  1. Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.\n  2. Disease stage II to IV by Ann Arbor Classification.\n  3. Life expectancy ≥ 12 months.\n* Cohort 2, 3:\n\n  1. Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).\n  2. Relapsed or refractory to first-line R-CHOP-like regimen.\n  3. For patients who have received only one line of therapy, if the patient has not received autologous stem cell transplantation, the investigator needs to assess as unsuitable or the patient refuses intensive chemotherapy and hematopoietic stem cell transplantation.\n  4. Life expectancy ≥ 6 months.\n* Patients must also meet all of the following criteria to be included in this study:\n\n  1. All patients must provide a signed and dated written informed consent prior to any study-specific procedure, sampling, and analysis.\n  2. Patients must be ≥ 18 years of age at the time of informed consent.\n  3. ECOG status score of 0 to 2.\n  4. Presence of at least one radiologically measurable lesion in 2 perpendicular directions as assessed by CT or MRI and a positive lesion on PET\u002FCT scan consistent with a tumor site identified by CT or MRI.\n  5. Adequate bone marrow hematopoietic reserve and organ function.\n  6. No uncontrolled medical complications.\n  7. Patients should be able to follow the relevant requirements of this study for medication and follow-up.\n  8. Willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n* Cohort 2, 3:\n\n  a. Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within 14 days prior to first dose. Chemotherapy and small-molecule targeted therapy were not terminated within 5 half-lives before the first dose; macromolecule drug therapy (such as antibody therapy) was not terminated within 28 days before the first dose.\n* All patients should not be included in this study if they have any of the following conditions:\n\n  1. Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.\n  2. Prior use of BTK inhibitors.\n  3. Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.\n  4. Currently taking vitamin K antagonists, taking 2 or more antiplatelet\u002Fanticoagulant drugs at the same time, drugs\u002Fherbs or supplements known to potently induce or inhibit CYP3A enzyme activity, proton pump inhibitor drugs, anti-tumor traditional Chinese medicine or failing to meet the protocol-specified withdrawal time before administration in this study.\n  5. Major surgery within 4 weeks or anticipated surgery after the start of this study. Or insufficiently recovered from any toxicity and\u002For complications of previous intervention.\n  6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.\n  7. Active infectious diseases.\n  8. Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug.\n  9. The patient has been diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.\n  10. Patients with hypersensitivity to DZD8586 drug excipients or other chemical analogues.\n  11. Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.\n  12. Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent\n  13. Women who are pregnant or breastfeeding.",{"count":134,"type":20},150,[114,23],"This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.",[138],"Diffuse Large B-Cell Lymphoma","2026-03-30",{"date":141,"type":31},"2026-04-01",{"date":143,"type":31},"2025-08-19",{"date":145,"type":20},"2030-10",{"name":37,"class":38},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100585656","phase-1-a-multinational-study-assessing-an-oral-egfr-inhibitor-dzd6008-in-patients-who-have-advanced-nsclc-with-egfr-mutations-tian-shan1-100585656","NCT06905197","A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)","A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)","Inclusion Criteria:\n\n1. Patients must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR mutations from a local CLIA-certified laboratory (or equivalent). For Part A monotherapy cohorts and all cohorts of Part B, EGFR sensitizing mutations (Exon19del and\u002For L858R) are required.\n5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment. (previously treated patients) or before study treatment (treatment naïve patients).\n6. Part A: Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen. Cohort A of Part B: Failed 1 prior third-generation EGFR TKI regimen. Cohorts B of Part B: Patients who are treatment naïve.\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Patients with brain metastases must have a stable BM status.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B).\n2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n3. Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration; 3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening; 4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration; 5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration; 6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration; 7)major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Patients with any other malignancy within 2 years of the first administration of study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.\n8. Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19.\n9. Resting QTcF \\> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases which would preclude adequate absorption of DZD6008.\n12. Received a live vaccine within 2 weeks before the first administration of DZD6008.\n13. Women who are pregnant or breastfeeding.\n14. Hypersensitivity to active or inactive excipients of DZD6008 or sunvozertinib.\n15. Involvement in the planning and conduct of the study.\n16. Judgment by the investigator that the patient is unlikely to comply with study procedures",{"count":155,"type":20},140,[114],"This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.",[159],"Non Small Cell Lung Cancer","2026-02-25",{"date":162,"type":31},"2026-02-27",{"date":164,"type":31},"2025-05-13",{"date":166,"type":20},"2028-12",{"name":37,"class":38},5,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100618176","phase-1-a-phase-12-study-of-gw5282-in-participants-with-advanced-solid-tumors-100618176","NCT07328217","A Phase 1\u002F2 Study of GW5282 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of GW5282 in Participants With Advanced Solid Tumors (BEI-DOU2)","Inclusion Criteria:\n\n1. All participants must provide a signed, dated written informed consent (ICF) prior to any study-specific procedures, sampling, and analysis.\n2. Male and female participants must be ≥18 years of age at the time of signing the ICF.\n3. Eastern Cooperative Oncology Group performance status of 0-1.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumors who has failed standard of cares (SoCs).\n5. Life expectancy ≥3 months.\n6. At least one measurable lesion according to RECIST 1.1.\n7. Tumor tissue sample requirements: sections of formalin-fixed paraffin-embedded (FFPE) tissue from freshly obtained biopsy sample or archived tumor sample.\n8. Adequate organ and marrow function.\n9. Participants should be able to comply with the requirements of this study for medication use and follow-up.\n10. If the female partner of a male participant has a potential for pregnancy, he must agree to use contraception (such as condoms) and refrain from donating sperm during the treatment period and for at least 6 months after the last dose of study treatment.\n11. Female participants should use adequate contraception during the treatment period and for at least 3 months after the last dose of study treatment. Female participants with potential pregnancy should have a negative pregnancy test prior to the first administration of investigational drug. Female participants may also be enrolled if they meet one of the following criteria:\n\n    * Postmenopausal women: older than 50 years and more than 12 months postmenopausal after discontinuation of all exogenous hormone therapy. Women under 50 years of age, more than 12 months postmenopausal after discontinuation of all exogenous hormone therapy, and with luteinizing hormone and follicle-stimulating hormone levels at postmenopausal levels.\n    * History of irreversible hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (excluding tubal ligation).\"\n\nExclusion Criteria:\n\n1. Any unresolved \\> grade 1 (according to CTCAE version 5.0) adverse event (excluding alopecia, anemia, neutropenia, and thrombocytopenia) prior to the first administration of investigational drug.\n2. Any known active central nervous system metastases and\u002For carcinomatous meningitis and\u002For spinal cord compression.\n3. Having any of the following treatment history:\n\n   * previously treated with GW5282 or other EZH pathway inhibitors.\n   * previously received any cytotoxic chemotherapy, investigational drug, or other anticancer drug (excluding macromolecular drugs) or clinical trial within 7 days or 5 half-lives (whichever is longer) prior to the first administration of the investigational drug.\n   * previously received any macromolecular drug (such as immunotherapy, monoclonal antibodies, bispecific antibodies, or antibody-drug conjugates) within 28 days prior to the first administration of the investigational drug.\n   * Underwent major surgery (excluding vascular access surgery) or suffered severe trauma within 4 weeks prior to the first administration of the investigational drug.\n   * Received limited field of radiation to alleviate symptoms within 7 days prior to the first administration of the investigational drug, or received more than 30% or extensive field of radiation to the bone marrow within 28 days prior to the first administration of the investigational drug.\n   * Received live-attenuated vaccine or viral vector vaccine within 4 weeks prior to the first administration of the investigational drug.\"\n4. Active infectious diseases.\n5. History of stroke or intracranial hemorrhage within 6 months prior to the first administration of the investigational drug.\n6. History of interstitial lung disease (ILD), radiation pneumonitis requiring corticosteroid therapy, or any clinically active interstitial lung disease, or immunotherapy-related pneumonitis.\n7. Uncontrolled systemic disease including uncontrolled hypertension and active bleeding after investigator's assessment.\n8. Judgment by the investigator that the participant is unlikely to comply with the study procedures, restrictions, and requirements.",{"count":177,"type":20},203,[114,23],"This is a phase 1\u002F2, open-label, multicenter study assessing the safety, tolerability, pharmacokinetics and efficacy of GW5282 in participants with locally advanced or metastatic solid tumors. This study comprised of a dose escalation phase to determine the MTD and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of GW5282.",[181],"Advanced Solid Tumors","2026-02-09",{"date":184,"type":31},"2026-02-11",{"date":186,"type":31},"2026-01-29",{"date":188,"type":20},"2029-06",{"name":37,"class":38},3,{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100615573","phase-2-a-study-of-dzd8586-in-adults-with-primary-immune-thrombocytopenia-itp-tai-shan11-100615573","NCT07294365","A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)","A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age.\n2. Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts \\\u003C 30 × 10⁹\u002FL.\n3. Have failed at least one standard treatment for ITP (glucocorticoids and\u002For IVIG).\n4. Adequate bone marrow reserve and organ functions.\n5. Willing to comply with contraceptive restrictions.\n\nExclusion Criteria:\n\n1. Have evidence of secondary causes of immune thrombocytopenia.\n2. Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.\n3. Any of previous or current treatment prohibited by protocol.\n4. Any of severe cardiac abnormalities.\n5. Active infection.\n6. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.\n7. Known allergy to DZD8586 drug excipients or other chemical analogues.\n8. Pregnant or breastfeeding female participants.",{"count":199,"type":20},60,[23],"This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP). The target population of this study is patients with primary ITP who had failed to respond or relapsed after receiving at least one standard therapy. Participants who meet the inclusion criteria and do not meet the exclusion criteria will be randomized to different dose groups.",[203],"Immune Thrombocytopenia (ITP)","2026-01-21",{"date":206,"type":31},"2026-01-22",{"date":208,"type":31},"2026-01-15",{"date":210,"type":20},"2027-12",{"name":37,"class":38},1,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100538791","phase-2-a-phase-ii-clinical-trial-of-dzd9008-in-combination-with-azd4205-in-standard-treatment-failed-nsclc-patients-with-egfr-mutations-wu-kong21-100538791","NCT06295432","A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)","A Phase II, Multicenter Study to Assess the Safety, Tolerability and Anti-tumor Efficacy of DZD9008 in Combination With AZD4205 in Standard Treatment Failed Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Mutations","Inclusion Criteria:\n\n1. Patients must be able to understand the nature of the trial and provide a signed and dated informed consent form prior to screening.\n2. Aged at least 18 years old when sign ICF.\n3. Histological or cytological confirmed locally advanced or metastatic NSCLC.\n4. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the previous 2 weeks.\n5. Predicted life expectancy ≥ 12 weeks.\n6. Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable e.g. no evidence of progression for at least 2 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance image \\[MRI\\] or computed tomography \\[CT\\] scan) during the screening period), neurologically asymptomatic and not require corticosteroid treatment.\n7. Adequate organ system functions, as outlined below\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n   * Absolute lymphocyte count ≥ 0.8 x 109\u002FL\n   * Platelets ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement or ≤ 5 x ULN with liver involvement\n   * Creatinine ≤ 1.5 x ULN, or measured creatinine clearance ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault method\n   * International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;\n   * Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN\n8. Male subjects with a female partner who intend to have children should use barrier contraception (e.g. condom) during their participation in the clinical study until 6 months after the last dose. Male subjects should not donate sperm during the clinical study until 6 months after the last dose. If the male subject has fertility requirements, it is recommended that sperm be frozen prior to the start of the clinical study.\n9. Female subjects should use contraception at screening until 6 weeks after the last dose of DZD9008 or 3 months after the last dose of AZD4205, whichever is later, should not be breastfeeding and should have a negative pregnancy test (blood or urine β-HCG) at the time of screening.\n\nPart A specific inclusion criteria:\n\n1. Subjects should harbour any type of EGFR mutation.\n2. Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic\u002Flocally advanced disease.\n\nPart B specific inclusion criteria:\n\n1. Subjects must have documented EGFR sensitizing mutation from a local certified laboratory.\n2. Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic\u002Flocally advanced disease.\n3. Patient must have measurable disease according to RECIST 1.1: At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for repeated measurement.\n4. Agree and be willing to provide an adequate amount of the required tumor tissue for exploratory studies.\n\nExclusion Criteria:\n\n1. Treatment with any of the followings:\n\n   * Prior treatment with any onco-immunotherapy (e.g. PD-1) within 4 weeks before the first administration of IP.\n   * Any cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen within 2 weeks before the first administration of IP.\n   * Radiotherapy within 2 weeks of the first dose or have not recovered from radiotherapy-related toxicity May receive palliative radiotherapy other than chest and brain, stereotactic radiosurgery and stereotactic body radiation therapy within 1 week prior to first dose a limited field of radiation for palliation within 1 week of the first administration of IP.\n   * Patients currently receiving (or unable to stop using) medications known to be potent inhibitors or inducers of CYP3A or herbal supplements within 2 weeks before the first administration of IP.\n   * Patients should avoid eating food known to be inhibitors of CYP3A such as grapefruit and Seville oranges (and other products containing these fruits, e.g., grapefruit juice or marmalade) within 2 weeks before the first administration of IP and 2 weeks after the therapy.\n   * Drugs that prolong the QT interval need to be discontinued before the start of IP\n   * Major surgery (excluding biopsy) within 4 weeks before the first administration of IP, or expect to have major surgery during study.\n   * Treatment with any investigational drug (or unable to stop using) within 4 weeks before the first administration of IP\n2. Spinal cord compression or leptomeningeal metastasis.\n3. Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer type which has been disease free for \\> 2 years with life expectancy \\>2 years\n4. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting IP with the exception of alopecia.\n5. History of stroke or intracranial haemorrhage within 6 months before the first administration of IP.\n6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia, Von Willebrand disease).\n7. Presence of persistent or active infection, including but not limited to:\n\n   * Active or latent tuberculosis\n   * Active herpes simplex, herpes zoster infection\n   * COVID-19\n   * active HBV, HCV, HIV infection\n8. Any of the following cardiac abnormal and disease:\n\n   * resting corrected QT interval (QTc) \\> 470 msec\n   * Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \\> 250 msec\n   * Any factors that increase the risk of QTc prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\n   * Prior history of atrial fibrillation except prior drug treatment related and recovered\n   * Prior history of myocardial infarction, congestive heart failure, arrhythmias that are poorly controlled by medication\n   * LVEF \\\u003C 55% accessed by ECHO\n9. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, immunotherapy-induced immune pneumonitis.\n10. Significant pulmonary function impairment (i.e. pulmonary function test showing FEV1 and DLCO \\\u003C 60% of expected values).\n11. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of IP.\n12. Receiving live vaccines within 2 weeks before the first administration of IP.\n13. Women who are pregnant or breast feeding.\n14. Involvement in the planning and conduct of the study (applies to Dizal staff or staff at the study site).\n15. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":221,"type":20},90,[23],"DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy.",[225],"Non-small Cell Lung Cancer","2025-12-24",{"date":228,"type":31},"2025-12-31",{"date":230,"type":31},"2023-06-01",{"date":232,"type":20},"2026-12",{"name":37,"class":38},4,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":212},"100578597","phase-1-assessing-an-oral-egfr-inhibitor-dzd6008-in-patients-who-have-advanced-nsclc-with-egfr-mutations-tian-shan2-100578597","NCT06813365","Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)","A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (TIAN-SHAN2)","Inclusion Criteria:\n\n1. Patients must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR sensitizing mutation (Exon19del and\u002For L858R) from a local CLIA-certified laboratory (or equivalent).\n5. Provide adequate amount of pretreatment tumor samples for retrospective confirmation of EGFR mutations by the central laboratory.\n6. Part A: Failed (progressed or are intolerant) at least 1 prior EGFR TKI and platinum-based chemotherapy. Part B: Cohorts 1 and 2: Failed 1 prior third-generation EGFR TKI. Cohorts 3 and 4: Patients who are treatment naïve.\n\n   Note: Patients enrolled in the study should be representative of the population to meet the need for efficacy analysis in the population after TKI failure (e.g., including appropriate proportion and number of patients with the C797X mutation if possible)\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Patients with brain metastases must have a stable BM status.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B).\n2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n3. Prior treatment with any of the following:1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration;2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration;3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening;4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration.5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration;6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration;7)Major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Patients with any other malignancy within 2 years of the first administration of study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.\n8. Patients with active infection including but not limited to HBV, HCV, HIV and active infection of COVID-19.\n9. Resting QTcF \\> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases which would preclude adequate absorption of DZD6008.\n12. Women who are pregnant or breastfeeding.\n13. Hypersensitivity to active or inactive excipients of DZD6008.\n14. Involvement in the planning and conduct of the study.\n15. Judgment by the investigator that the patients is unlikely to comply with study procedures",{"count":243,"type":20},190,[114],"This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.",[247],"Nonsmall-cell Lung Cancer",[249],"Lung Cancer, EGFR mutation","2025-12-23",{"date":252,"type":31},"2025-12-30",{"date":254,"type":31},"2024-06-12",{"date":256,"type":20},"2028-07-30",{"name":37,"class":38},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"locationsCount":212},"100598357","phase-1-dzd6008-combination-therapy-in-patients-with-locally-advanced-or-metastatic-nsclc-with-egfr-mutation-tian-shan7-100598357","NCT07070440","DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)","A Phase 1\u002F2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥18 years old.\n3. Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.\n4. Documentation of EGFR sensitizing mutation confirmed by local laboratory.\n5. Provide sufficient tumor tissue samples and plasma samples for retrospective analysis of EGFR mutations by central laboratory.\n6. Failure of prior 3 generations EGFR TKI.\n7. ECOG status score 0-1, life expectancy ≥12 weeks.\n8. No central nervous system symptoms during screening, no need for corticosteroids or dehydration diuretic treatment for at least 4 weeks before the first dosing. If the patient with brain metastasis has received radiotherapy or surgery, there is a washout period of ≥2 weeks before the first use of DZD6008 and ensure that the AE related to radiotherapy or surgery has recovered to ≤ 1 grade.\n9. Presence of measurable lesions defined by RECIST 1.1.\n10. Sufficient bone marrow or other organ reserve before first dosing.\n\nExclusion criteria\n\n1. Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation.\n2. Received the following treatments or had the following lifestyle habits, etc.:\n\n   * Received immunotherapy or other antibody treatments (including EGFR-targeted antibodies, bispecific antibodies or antibody-drug conjugates, etc.) within 4 weeks before the first study drug administration.\n   * Received any cytotoxic chemotherapy, study drugs or other anti-cancer drugs (excluding macromolecule drugs) within 14 days before the first study drug administration.\n   * Received limited-range radiotherapy to relieve the disease within 7 days before the first study drug administration, or received more than 30% of the bone marrow radiotherapy or received wide-range radiotherapy within 28 days before the first medication.\n   * 2 weeks (for CYP3A4 inhibitors) or 3 weeks (for CYP3A4 inducers) before the first study drug administration, are taking or cannot stop taking known cytochrome P450 (CYP) 3A4 strong inhibitors or inducers (including herbal supplements, such as St. John's wort).\n   * 2 weeks before the first study drug administration, are taking or cannot stop taking known CYP3A4 sensitive substrate drugs (with a narrow therapeutic window).\n   * Taking or being unable to stop taking drugs known to be proton pump inhibitors within 1 week before the first study drug administration.\n   * Major invasive surgery has been performed within 4 weeks before the first study drug administration or is planned during treatment.\n3. Presence of AEs of ≥1 grade (except any degree of alopecia) caused by previous treatment (such as adjuvant chemotherapy, radiotherapy).\n4. Tumor-related spinal cord compression or meningeal metastasis.\n5. History of malignant tumor within 2 years (except for basal cell carcinoma of the skin or cervical cancer in situ that has been adequately treated; other tumors that have been tumor-free for more than 2 years and are expected to survive for more than 2 years, which needs to be discussed with Dizal clinical research physicians).\n6. Presence of severe or uncontrollable systemic diseases, including poorly controlled hypertension, bleeding diseases.\n7. Presence of persistent or active infections, including but not limited to hepatitis B, hepatitis C and human immunodeficiency virus infection (HIV).\n8. Any of the following heart-related diseases or abnormalities:\n\n   * QT interval (QTc) \\>470 msec after calibration of 12-lead ECG at rest during the screening period.\n   * Any serious abnormalities of heart rate, conduction or pattern shown on the ECG at rest, such as complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec.\n   * Any disease or condition that can cause QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or family members with a history of sudden death under the age of 40.\n   * Severe cardiovascular diseases such as myocardial infarction, unstable angina or congestive heart failure, cerebrovascular accident (such as history of stroke or intracranial hemorrhage) within 6 months before the first dose.\n   * History of deep vein thrombosis or pulmonary embolism within 4 weeks before the first dose (excluding non-obstructive catheter-related thrombosis).\n9. Patient history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid hormone treatment, or any clinically active ILD, immunotherapy-related pneumonitis.\n10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, or previous intestinal resection that prevents adequate absorption of study medication.\n11. Live vaccine within 4 weeks before the first dose.",{"count":266,"type":20},100,[114,23],"This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.",[159],"2025-08-25",{"date":272,"type":31},"2025-08-29",{"date":274,"type":31},"2025-07-16",{"date":166,"type":20},{"name":37,"class":38},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":212},"100537319","phase-2-dzd9008-in-combination-with-bevacizumab-in-locally-advanced-or-metastatic-nsclc-patients-with-egfr-mutation-wu-kong29-100537319","NCT06276283","DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)","A Phase II, Single Arm, Multicenter Study to Assess the Safety, Tolerability and Anti-Tumor Efficacy of DZD9008 With Bevacizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Mutations (WU-KONG29)","Inclusion Criteria:\n\nPatients must meet all the following criteria for inclusion in the study:\n\n1. Sufficient understanding of nature of the trial and provision of informed consent with hand-written signatures and the date of signature prior to any study-specific procedures, sampling, and analyses.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed and locally advanced or metastatic non-squamous NSCLC.\n4. Written documentation of EGFR mutations from an accredited local laboratory: Part A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.\n5. ECOG score ≤ 1 without clinically significant disease deterioration within 2 weeks prior to the informed consent process and a life expectancy ≥ 12 weeks.\n6. Patients with stable brain metastasis provided no evidence of progression for at least 2 weeks, as ascertained by brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the screening period, no neurological symptoms, and no requirement of Steroids.\n7. Part A includes patients who have progressed after or cannot tolerate the standard of care\n8. Part B includes patients with NSCLC who have progressed after or cannot tolerate standard of care. Treatment naïve patients will be enrolled after an adequate evaluation of the safety data by the Safety Review Committee (Note: Patients who have received (neo)adjuvant therapy are allowed to participate in the study, if the (neo)adjuvant therapy is administrated at least 6 months prior to the diagnosis of locally advanced or metastatic NSCLC) .\n9. Measurable lesions, according to RECIST 1.1: at least one lesion, not previous irradiated, with the longest diameter ≥ 10 mm at baseline (lymph nodes must have a short axis of ≥ 15 mm), that can be accurately measured at baseline and thereafter with MRI or CT scan.\n10. Male patients with a female partner or fertility desire should be willing to use barrier contraception (e.g., condoms) until 6 months after the last dose. Male patients should not donate sperms until 6 months after the last dose. Male patients with fertility desire are suggested to freeze their sperm before entering the study.\n11. Female patients should be willing to use adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test (i.e., urine and blood pregnancy human chorionic gonadotropin testing); or female patients meet the following criteria:\n\n    * Post-menopausal defined as age more than 60 and amenorrheic for at least 12 months after all exogenous hormonal treatments.\n    * Women under 60 years old would be considered post-menopausal if they have been amenorrheic for at least 12 months with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range.\n    * Documentation of irreversible surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation).\n\nExclusion Criteria:\n\nPatients must not enter the study if any of the following exclusion criteria are met:\n\n1. Treatment with any of the following:\n\n   * Treatment with poziotinib, mobocertinib (TAK788), CLN-081, BDTX-189, aumolertinib, AP-L1898, and other EGFR Exon20ins inhibitors prior to the first dose of study drug (only applicable to Part B).\n   * Prior treatment with 1st to 3rd generation EGFR-TKIs (e.g., gefitinib, erlotinib, icotinib, osimertinib, afatinib, dacomitinib, and ametinib) and have had an objective response (i.e., PR and CR) (only applicable to Part B).\n   * Prior systemic treatment for locally advanced or metastatic NSCLC (only applicable to treatment naïve patients in Part B)\n   * Treatment with EGFR, HER2, or VEGFR antibody within 4 weeks of the first dose of study drug.\n   * Chemotherapy or other anti-tumor therapies within 2 weeks of the first dose of study drug.\n   * Radiotherapy within 14 days of the first dose of study drug or unresolved radiotherapy-related toxicities. Patients could receive palliative radiotherapy for tumor lesions outside of brain and chest, stereotactic radiosurgery, and stereotactic body radiotherapy.\n   * Current treatment within 1-2 weeks of the first dose of study drug with medications or herbal supplements known to be potent inhibitors (1 week) or inducers (2 weeks) of cytochrome P450 (CYP) 3A4.\n   * Major surgery, excluding biopsy and diagnostic surgery, within 4 weeks of the dose of study drug, or expected major surgeries during the study period.\n   * Treatment with an investigational drug within 5 half-lives of the compound. Patient\n2. Spinal cord compression or leptomeningeal metastasis.\n3. Concurrent EGFR mutations with approved EGFR-TKIs (e.g., Exon19del, L858R, T790M, G718X, S768I and L861Q; only applicable to Part B).\n4. History of malignancy within 2 years of the first dose of study drug (excluding adequately treated Basal cell carcinoma or in situ cervical cancer with a tumor-free period of more than 2 years and a life expectancy of more than 2 years. The inclusion of such patients should be discussed with the study physician from Dizal Pharma).\n5. Any unresolved toxicities from prior systemic therapy (e.g., adjuvant chemotherapy and radiotherapy) \\> CTCAE grade 1 at the time of starting study drug except for alopecia and grade 2 neuropathy related to previous platinum-based therapy.\n6. History of stroke and intracranial hemorrhage within 6 months of the first dose of study drug.\n7. Any evidence of severe or uncontrolled systematic disease based on the investigator's opinion, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia and von Willebrand disease).\n8. Any evidence of active infection, including but not limited to hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and COVID-19. The diagnosis of COVID-19 follows the local practice.\n\n   Test Include if Exclude if HIV antibody (-) (+) HCV antibody (-) (+) HBV antibody HbsAg (-) and HbcAb (-) HbsAg (+) and HBV DNA ≥ 1000 IU\u002FmL HbsAg (-), HbcAb (+) and HBV DNA \\\u003C 1000 IU\u002FmL HbsAg (-), HbcAb (+), and HBV DNA ≥ 1000 IU\u002FmL (-), Negative; (+), Positive.\n9. Any of the following cardiac events or abnormalities:\n\n   * Mean resting corrected QT interval (QTcF) \\> 470 msec.\n   * Any clinically significant abnormalities in rhythm, conduction, or morphology detected by resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, and PR interval \\> 250 msec.\n   * Any factors that can lead to QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, family history of unexplained sudden death under 40 years of age, or any comorbidities known to prolong the QT interval.\n   * Any evidence of atrial fibrillation (except for drug-related atrial fibrillation that has been resolved after drug discontinuation).\n   * Any evidence of myocadiac infraction, congestive heart failure (New York Heart Association Class II or above), and uncontrolled arrhythmia with medication within 6 months of the first dose of study drug.\n10. History of interstitial lung disease (ILD), drug-induced ILD, and immune-related pneumonitis due to cancer immunotherapy.\n11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing the study drug, or previous bowel resection that would preclude adequate absorption of DZD9008.\n12. Inadequate bone marrow reserve or organ function:\n\n    * Absolute neutrophil count \\\u003C 1.5 × 109\u002FL\n    * Platelet count \\\u003C 100 ×109\u002FL\n    * Hemoglobin \\\u003C 9 g\u002FdL\n    * Total bilirubin \\>1.5 × ULN if no liver metastases or \\>3 × the upper limit of normal (ULN) in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST \\>2.5 × ULN if no demonstrable liver metastases or \\>5 × ULN in the presence of liver metastases.\n    * Creatinine ≥1.5 × ULN or creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation)\n    * The international normalized ratio \\> 1.5 × ULN and activated partial thromboplastin time (APTT) \\> 1.5 × ULN\n    * Serum lipase) \\> 1.5 × ULN and serum amylase \\> 1.5 × ULN\n13. Live virus vaccines administrated within 2 weeks of the first dose of study drug.\n14. Pregnant women or women who are breastfeeding.\n15. Concurrent contraindications to bevacizumab, including but not limited to:\n\n    * Deep vein thrombosis ≥ CTCAE grade 3\n    * Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg)\n    * Intracerebral hemorrhage, including hemorrhage caused by metastatic brain tumors.\n    * History of severe proteinuria (urine dipstick protein 2+ or 24-hour urine protein \\> 2g)\n    * History of hypertensive crisis and hypertensive encephalopathy\n    * History of central nervous system diseases that are not related to the tumor (e.g., convulsions)\n    * History of vascular events within 6 months of the first dose of study drug (e.g., aneurysm requiring treatment)\n    * History of hemoptysis within 3 months of the first dose of study drug (two spoonfuls of blood each time)\n    * History of bleeding disorders or coagulation disorders without treatment of anticoagulants.\n    * Tumor invasion of major vessels\n    * History of gastrointestinal perforation or fistula within 6 months of the first dose of study drug\n16. Severe allergic reaction to DZD9008, bevacizumab, or their excipients.\n17. Subjects who are involved in the design, planning, or conduct of the study (applicable to employees of Dizal Pharm and staff at investigational sites).\n18. Poor compliance or inability to participate in clinical studies according to the investigator's assessment.",{"count":199,"type":20},[23],"This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab.",[225],"2025-06-16",{"date":290,"type":31},"2025-06-19",{"date":292,"type":31},"2023-02-15",{"date":294,"type":20},"2026-02-28",{"name":37,"class":38},""]