[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659545":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":61,"studyPopulation":11,"armGroups":62,"interventions":69,"overallOfficials":11,"centralContacts":75,"locations":11,"responsibleParty":81,"collaborators":11,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":11},{"fullName":5,"class":6},"Chengdu Anticancer Bioscience, Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":11},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Phase Ia: dose-limiting toxicities (DLTs)",null,"Cycle 1, Days 1-21 after the first dose (21-day DLT assessment period)",{"measure":14,"description":11,"timeFrame":15},"Phase Ia: maximum tolerated dose (MTD)","At completion of Phase Ia dose escalation, after completion of the 21-day DLT assessment period for each dose cohort, up to approximately 15 months after the first participant receives the first dose.",{"measure":17,"description":11,"timeFrame":18},"Phase 1a：recommended dose for expansion (RDE)","At completion of Phase Ia dose escalation, after review of DLTs and other available safety data, up to approximately 15 months after the first participant receives the first dose.",{"measure":20,"description":11,"timeFrame":21},"Phase Ia\u002FIb: adverse events (AEs), serious adverse events (SAEs)","From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first",{"measure":23,"description":11,"timeFrame":24},"Phase Ib: determination of the recommended Phase II dose (RP2D)","From the first dose administered to the first participant in Phase Ia through completion of Phase Ib dose expansion, up to approximately 27 months.",{"measure":26,"description":11,"timeFrame":27},"Phase II: Objective response rate (ORR)","From baseline until disease progression, initiation of new anticancer therapy, or withdrawal, assessed up to approximately 24 months.",[29,32,34,36,38,40,43,46,49,52],{"measure":30,"description":11,"timeFrame":31},"Phase Ia\u002FIb\u002FII: maximum plasma concentration (Cmax)","During the first cycle of treatment (21 days)",{"measure":33,"description":11,"timeFrame":31},"Phase Ia\u002FIb\u002FII: time to maximum plasma concentration (Tmax)",{"measure":35,"description":11,"timeFrame":31},"Phase Ia\u002FIb\u002FII: area under the concentration-time curve (AUC)",{"measure":37,"description":11,"timeFrame":31},"Phase Ia\u002FIb\u002FII: elimination half-life (t1\u002F2)",{"measure":39,"description":11,"timeFrame":27},"Phase II: Disease Control Rate (DCR)",{"measure":41,"description":11,"timeFrame":42},"Phase II: adverse events (AEs), serious adverse events (SAEs)","From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first.",{"measure":44,"description":11,"timeFrame":45},"Phase II: Progression-Free Survival (PFS)","From the first dose until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.",{"measure":47,"description":11,"timeFrame":48},"Duration of Response (DoR)","From the first documented CR or PR until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.",{"measure":50,"description":11,"timeFrame":51},"Phase II: Time to Response (TTR)","From the first dose until the first documented CR or PR, assessed up to approximately 24 months.",{"measure":53,"description":11,"timeFrame":54},"Phase II: Time to Progression (TTP)","From the first dose until disease progression, assessed up to approximately 24 months.",{"allocation":56,"interventionModel":57,"interventionModelDescription":11,"primaryPurpose":58,"observationalModel":11,"timePerspective":11,"maskingInfo":59},"NA","SINGLE_GROUP","TREATMENT",{"masking":60,"maskingDescription":11,"whoMasked":11},"NONE","The purpose of this clinical trial is to investigate JMBI-001 for the treatment of MYC-positive advanced tumors and to evaluate its safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and antitumor efficacy.\n\nThe main questions this study aims to answer are:\n\n1. To evaluate the safety, tolerability, PK, and preliminary antitumor activity of JMBI-001, and to determine the recommended dose for expansion (RDE) and the recommended Phase II dose (RP2D).\n2. To evaluate the antitumor efficacy, safety, tolerability, and PK of JMBI-001 at the RP2D in selected tumor types.\n\nParticipants will:\n\n1. Take JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Three such 7-day dosing periods will constitute one 21-day treatment cycle.\n2. Visit the study site as scheduled to undergo protocol-specified procedures, including medical interviews, physical examinations, blood tests, electrocardiograms, and imaging examinations.\n3. Continue treatment until a protocol-defined event requiring discontinuation of study treatment or withdrawal from the study occurs.",[63],{"label":64,"type":65,"description":66,"interventionNames":67},"JMBI-001 Monotherapy","EXPERIMENTAL","Participants will receive JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Each 21-day treatment cycle consists of three consecutive 7-day dosing periods.",[68],"Drug: JMBI-001 Tablets",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":11},"DRUG","JMBI-001 Tablets","JMBI-001 will be administered orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment, in repeated 21-day treatment cycles. Dose levels will be determined according to the study protocol.",[64],[76],{"name":77,"role":78,"phone":79,"phoneExt":11,"email":80},"Clinical Trial Information Team","CONTACT","+86 28 85185225","JMBIClinicalTrials@anticancerbio.com",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659545","phase-1-study-of-jmbi-001-in-patients-with-myc-positive-advanced-cancers-100659545",false,"NCT07864701","Study of JMBI-001 in Patients With MYC-Positive Advanced Cancers","A Phase I\u002FII Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity and Efficacy of JMBI-001 Tablets in Participants With MYC-Positive Advanced Solid Tumors or Relapsed\u002FRefractory Non-Hodgkin Lymphoma","PANGU-1","Inclusion Criteria:\n\n* Able to fully understand the study requirements, voluntarily agree to participate in the study, and provide written informed consent.\n* Male or female participants aged 18 to 75 years, inclusive.\n* Histologically or cytologically confirmed malignant tumor. Participants with solid tumors must have unresectable locally advanced or metastatic disease for which standard treatment has failed, is not tolerated, or is unavailable. Participants with non-Hodgkin lymphoma must have received at least two prior lines of therapy. Tumor-specific requirements for each study phase are as follows:\n\n  1. Phase Ia dose-escalation stage: Solid tumors, including but not limited to gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and triple-negative breast cancer. Non-Hodgkin lymphoma, including but not limited to diffuse large B-cell lymphoma and Burkitt lymphoma.\n  2. Phase Ib dose-expansion stage: tumor indications within prespecified tumor types of particular interest, potentially sensitive tumor types or subtypes identified during Phase Ia, or both. Prespecified tumor types of particular interest include, but are not limited to, gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and non-Hodgkin lymphoma.\n  3. Phase II indication-expansion stage: selected tumor indications that meet the prespecified transition criteria during Phase Ib.\n* Except for participants enrolled in the accelerated titration stage of Phase Ia, tumor tissue obtained or submitted during screening must be tested by immunohistochemistry and meet the following criteria for MYC positivity:\n\n  1. Solid tumors: MYC-positive tumor cell nuclei in at least 10% of tumor cells.\n  2. Non-Hodgkin lymphoma: MYC-positive tumor cell nuclei in at least 40% of tumor cells.\n* At least one lesion suitable for efficacy assessment, as follows:\n\n  1. For participants with solid tumors, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). The longest diameter must be at least 10 mm on spiral computed tomography, or the short-axis diameter of an enlarged lymph node must be at least 15 mm. A lesion selected as a target lesion must not have received radiotherapy within 4 weeks before the first dose of JMBI-001; palliative local radiotherapy to a non-target lesion is permitted.\n  2. For participants with non-Hodgkin lymphoma, according to the Lugano 2014 criteria, the longest diameter must be greater than 1.5 cm for a nodal lesion or greater than 1.0 cm for an extranodal lesion.\n\nExclusion Criteria:\n\n* Difficulty swallowing or inability to swallow tablets.\n* Known hypersensitivity to any component of JMBI-001 tablets.\n* Carcinomatous meningitis, brainstem metastasis, or spinal cord compression confirmed by imaging or clinical diagnosis.\n* History of a severe neurologic disorder or severe psychiatric or psychological disorder that may interfere with the participant's ability to understand or comply with the study protocol.\n* Systemic glucocorticoid therapy within 2 weeks before the first dose of JMBI-001 at a prednisone-equivalent dose greater than 10 mg\u002Fday.\n* Gastrointestinal disease or abnormality that may affect the absorption of JMBI-001, including but not limited to celiac disease, short bowel syndrome, Crohn disease, ulcerative colitis, gastrointestinal perforation, or severe vomiting or diarrhea.\n\nOther Inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","75 Years",{"count":95,"type":96},150,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE1","PHASE2","Evaluate the safety and tolerability of JMBI-001 in adults with MYC-positive advanced cancers.",[103,104],"Advance Solid Tumors","Lymphoma, Non-Hodgkin",[106,107,108,109,110,111],"MYC-Positive Tumor","MKLP2","KIF20A","JMBI-001","MYC","Anticancer Bioscience","NOT_YET_RECRUITING","2026-10-02",{"date":115,"type":116},"2026-10-08","ACTUAL",{"date":118,"type":96},"2026-10",{"date":120,"type":96},"2030-06",{"name":5,"class":6}]