[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560456":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":29,"centralContacts":29,"locations":29,"responsibleParty":56,"collaborators":29,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":29,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":29,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":29,"overallStatus":80,"whyStopped":29,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":29},{"fullName":5,"class":6},"Shanghai Runshi Pharmaceutical Technology Co., Ltd","INDUSTRY",[8,15,19,23,27,32],{"label":9,"type":10,"description":11,"interventionNames":12},"DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 1, D1-D21, Q4W","EXPERIMENTAL","DP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 1, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W",[13,14],"Drug: DP303c","Drug: Simmitinib tablets",{"label":16,"type":10,"description":17,"interventionNames":18},"DP303c injection, dose level 1, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W","DP303c injection, dose level 1, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"DP303c injection, dose level 1, Q2W + simmitinib tablets, dose level 2, D1-D21, Q4W","DP303c injection, dose level 1, intravenous drip, Q2W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"DP303c injection, dose level 2, Q3W + simmitinib tablets, dose level 2, D1-D21, Q4W","DP303c injection, dose level 2, intravenous drip, Q3W + simmitinib tablets, dose level 2, oral, QD, taken for 3 weeks, discontinued for 1 week, Q4W",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"DP303c RP2D + irinotecan liposomes RP2D",null,[13,31],"Drug: Irinotecan liposomes",{"label":33,"type":34,"description":35,"interventionNames":36},"Single agent chemotherapy chosen by researchers","ACTIVE_COMPARATOR","Single agent chemotherapy chosen by researchers: paclitaxel, docetaxel, or irinotecan",[37],"Drug: Paclitaxel or docetaxel or irinotecan",[39,44,48,52],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":29},"DRUG","DP303c","DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker",[28,20,9,16,24],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"Simmitinib tablets","A novel small molecule inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR2, KDR), and colony-stimulating factor 1 receptor (CSF-1R)",[20,9,16,24],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":29},"Irinotecan liposomes","A chemotherapy",[28],{"type":40,"name":53,"description":54,"armGroupLabels":55,"otherNames":29},"Paclitaxel or docetaxel or irinotecan","Paclitaxel or docetaxel or irinotecan is used as a control.",[33],{"type":57,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100560456","phase-1-a-phase-study-of-simmitinib-or-irinotecan-liposomes-combined-with-dp303c-in-gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-100560456",false,"NCT06577376","A PhaseⅠ\u002FⅡ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","A Multicenter, Open-label Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* 1\\. Aged 18-75 (including) years old; 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum\u002Ffluorouracil combination chemotherapy with or without immune checkpoint inhibitors); 4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),; 5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2); 6. Adequate organ or bone marrow function\n\nExclusion Criteria:\n\n* \\*Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Aged 18-75 (including) years old;\n2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;\n3. Disease progression after receiving one or two lines of systemic treatment in the past (first-line treatment must be platinum\u002Ffluorouracil combination chemotherapy with or without immune checkpoint inhibitors);\n4. There should be at least one measurable lesion according to the response evaluation criteria in solid tumors (RECIST v1.1),;\n5. HER2 expression status: 2+ to 3+(applicable to Cohort 1) or 1+(applicable to Cohort 2);\n6. Adequate organ or bone marrow function\n\nExclusion Criteria:\n\n1. Patients who have experienced toxicity during previous treatment with trastuzumab or trastuzumab biosimilars, resulting in permanent discontinuation of trastuzumab or trastuzumab biosimilars;\n2. Patients with a history of allergies to any component of DP303c and deemed severe by the researchers\n3. There is uncontrolled serosal fluid accumulation that requires frequent drainage or medical intervention;\n4. Active leptomeningeal disease or uncontrolled CNS metastasis;\n5. Has a history of serious cardiovascular and cerebrovascular diseases;\n6. There was a peripheral neuropathy of grade ≥ 2 (refer to NCI CTCAE 5.0) prior to enrollment;\n7. History of gastrointestinal perforation and\u002For fistula within 6 months of first use of medication;\n8. Inability to swallow medication orally or presence of clinically significant gastrointestinal diseases;\n9. Urine protein ≥++ and 24-hour urine protein quantification\\>1.0 g during screening period;\n10. There are eye diseases that require intervention, such as corneal diseases, retinal diseases, or active eye infections;\n11. Used CYP3A4 strong inhibitors or CYP3A4 strong inducers 14 days before the first medication ;\n12. Used UGT1A1 strong inhibitor before first medication and wash-off period is less than 5 half-lives.","ALL","18 Years","75 Years",{"count":69,"type":70},252,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation\u002Fdose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.",[77,78,79],"Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)","Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past","NOT_YET_RECRUITING","2024-09-02",{"date":83,"type":84},"2024-09-05","ACTUAL",{"date":86,"type":70},"2024-08-26",{"date":88,"type":70},"2027-08-26",{"name":5,"class":6}]