[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-esophageal-junction-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-esophageal-junction-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,98],{"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":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100516513","phase-1-study-of-azd5863-in-adult-participants-with-advanced-or-metastatic-solid-tumors-100516513",false,"NCT06005493","Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 at the time of signing the informed consent\n* Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas\n* Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)\n* Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening\n* Predicted life expectancy of ≥ 12 weeks\n* Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol\n* Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol\n* Must have received at least one prior line of systemic therapy in the advanced\u002Fmetastatic setting\n\nKey Exclusion Criteria:\n\n* Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol\n* Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy\n* Previous history of hemophagocytic lymphohistiocytosis (HLH) \u002F macrophage activation syndrome (MAS)\n* Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment\n* central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent\n* Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B\u002FC, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection\n* Cardiac conditions as defined by the protocol\n* History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention\n* Participant requires chronic immunosuppressive therapy\n* Participants on anticoagulation therapy with long-acting anticoagulants or other class of anticoagulants at therapeutic doses","ALL","18 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.",[27,28,29,30],"Gastric Cancer","Gastro-esophageal Junction Cancer","Pancreatic Ductal Adenocarcinoma","Esophageal Adenocarcinoma",[32,33,34,35,36,37,38,39],"CLDN18.2 \u002F Claudin 18.2","CD3","T cell-engaging bi-specific antibody","Gastric cancer","Gastro-esophageal junction cancer","Pancreatic ductal adenocarcinoma","Solid tumors","AZD5863","RECRUITING","2026-02-23",{"date":43,"type":44},"2026-02-24","ACTUAL",{"date":46,"type":44},"2023-07-11",{"date":48,"type":20},"2027-07-16",{"name":50,"class":51},"AstraZeneca","INDUSTRY",25,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100573637","phase-1-epitome-1015-i-a-study-to-investigate-the-safety-and-tolerability-of-mdg1015-in-patients-with-epithelial-ovarian-cancer-gastroesophageal-adenocarcinoma-round-cell-liposarcoma-andor-synovial-sarcoma-100573637","NCT06748872","EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer, Gastroesophageal Adenocarcinoma, Round Cell Liposarcoma And\u002For Synovial Sarcoma","EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And\u002For Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And\u002For LAGE-1a","EPITOME-1015-I","Inclusion Criteria:\n\n1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4\n2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma\n3. Subject's must have tested positive for HLA-A\\*02:01 genotype by a Sponsor designated central laboratory\n4. Subject's tumor must have tested positive for NY-ESO-1 and\u002For LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed\n5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit\n6. Subjects must have\n\n   1. measurable disease\n   2. Life expectancy ≥ 3 months per Investigator's opinion\n\n8\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior\u002Fongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)\n\nExclusion Criteria:\n\n1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined\n2. HLA-A\\*02:02 or HLA-A\\*02:03 genotype\n3. Pregnant or lactating women\n4. Viral serology:\n\n   1. Known infection with HIV-1\u002F2, CMV (CMV required only for U.S. sites) or HTLV-1\u002F2,\n   2. Active infection with HBV or HCV\n   3. Positive test for Mycoplasma or Treponema Pallidum\n5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)\n6. Inadequate venous access for or contraindications to leukapheresis\n7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.\n8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease\n9. Unstable\u002Factive ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding\n10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:\n\n    1. non-melanoma skin cancer\n    2. curatively treated localized prostate cancer\n    3. carcinoma in situ (e.g. cervix, bladder, breast)\n11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (\\> 30 seconds) ventricular tachyarrhythmias\n12. Subjects who are dependent on dialysis\n13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator\n14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease\n15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant\n\n    Specific to GAC\u002FGEJ Subjects:\n16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation",{"count":62,"type":20},55,[23],"MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1\u002FLAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and\u002For synovial sarcoma that expresses NY-ESO-1 and\u002For LAGE-1a.\n\nThe main questions this clinical trial aims to answer are:\n\nCan this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015?\n\nParticipants will:\n\nReceive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and\u002For potential disease response will be documented during this period.",[66,28,67,68,69],"Epithelial Ovarian Cancer","Soft Tissue Sarcoma (STS)","Myxoid Liposarcoma","Synovial Sarcoma",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],"TCR-T Therapy","dose escalation","Third Generation TCR-T Therapy","autologous, patient derived CD8+ T cells","single arm","open label","phase I","BOIN design","NY-ESO-1","LAGE-1a","solid tumors","PD1-41BB","Costimulatory Switch Protein","Armoring","Enhancement","First-in-human","NOT_YET_RECRUITING","2024-12-23",{"date":90,"type":44},"2024-12-27",{"date":92,"type":20},"2025-07-01",{"date":94,"type":20},"2042-08-01",{"name":96,"class":51},"Medigene AG",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":97},"100550481","phase-2-perioperative-surufatinib-plus-sintilimab-combined-with-chemotherapy-in-gastricgastroesophageal-junction-adenocarcinoma-100550481","NCT06447636","Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric\u002FGastroesophageal Junction Adenocarcinoma","Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial","Inclusion Criteria:\n\n* signed informed consent\n* patients age 18-75 years;\n* Histologically CT\u002FMRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;\n* ECOG 0-1, no surgery contraindications;\n* Expected survival ≥3 months;\n\nExclusion Criteria:\n\n* signs of distant metastases\n* Prior chemotherapy, radiotherapy, surgery for gastric cancer;\n* Significant cardiovascular disease\n* major surgical procedure within 4 weeks prior to initiation of study treatment\n* current treatment with anti-viral therapy or HBV\n* pregnancy or breastfeeding\n* history of malignancy within 5 years prior to screening\n* Present or history of any autoimmune disease or immune deficiency;\n* Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;\n* There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.\n* Poorly controlled hypertension or diabetes;","75 Years",{"count":107,"type":20},20,[24],"For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.",[27,111],"Gastro Esophageal Junction Cancer","2024-06-03",{"date":114,"type":44},"2024-06-07",{"date":116,"type":20},"2024-08-01",{"date":118,"type":20},"2028-08",{"name":120,"class":121},"Fudan University","OTHER"]