[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Transcenta Therapeutics (Hangzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100523269","phase-3-combination-of-osemitamab-tst001-pembrolizumab-and-chemotherapy-as-first-line-therapy-in-advanced-or-metastatic-gcgej-adenocarcinoma-100523269",false,"NCT06093425","Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC\u002FGEJ Adenocarcinoma","A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Pembrolizumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G\u002FGEJ) Adenocarcinoma","Inclusion Criteria:\n\n* 1\\. ≥18 years of age on day of signing informed consent. 2. Histologically or cytologically confirmed diagnosis of previously untreated, unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma.\n\n  3\\. Must be willing and able to provide archival or fresh tissue sample, a formalin-fixed, paraffin-embedded (FFPE) block, or 151 or more unstained, freshly cut, serial sections (on slides) from an FFPE tumor specimen or fresh biopsy tissue from a tumor lesion (either primary or metastatic) not previously irradiated fixed in formalin solution. FFPE tissue blocks are preferred to slides. Notes: details pertaining to tumor tissue submission can be found in the Laboratory Manual. Fresh biopsies are not required for study entry and will not be covered as part of the study procedures. Handling of the fresh biopsy tissue is an alternative offered to investigators in case they plan to biopsy the subjects as part of their standard of care; the fresh sample can be sent directly to the central laboratory if it is more convenient to the sites.\n\n  4\\. Positive CLDN18.2 expression in tumor tissue confirmed by the central laboratory at screening using CTA (Claudin 18.2 IHC 14G11 pharmDx).\n\n  5\\. Must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria as assessed locally by the investigator; radiographic tumor assessment should be performed within 28 days prior to randomization.\n\n  6\\. Subjects should be eligible to receive chemotherapy and pembrolizumab per the investigator judgement.\n\n  7\\. Known PD-L1 CPS Status (tested by central laboratory to provide CPS status by PD-L1 IHC 22C3 pharmDx).\n\n  8\\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.\n\n  9\\. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or pre-treatment status. Subjects with endocrine-related AEs who are adequately treated with hormone replacement or subjects who have ≤Grade 2 neuropathy are eligible.\n\n  10\\. Have a life expectancy of greater than 12 weeks. 11. Demonstrate adequate organ function.\n\nExclusion Criteria\n\n1. Has received any prior systemic anticancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy) for G\u002FGEJ adenocarcinoma. Neo\u002Fadjuvant treatment is permitted as long as it was completed at least 6 months prior to randomization.\n2. Has received prior radiotherapy within 2 weeks before randomization; Note: Subjects must have recovered from all radiation-related toxicities. A previously irradiated lesion can be used as measurable lesion as long as it progressed post radiation therapy.\n3. Has received anti-CLDN18.2 agents at any time.\n4. Has received any traditional Chinese medicine or proprietary Chinese medicine with anti-tumor effect within 7 days before randomization.\n5. Has received vaccines (live, attenuated, or research vaccines) within 30 days before randomization. Administration of killed vaccines is allowed.","ALL","18 Years",{"count":19,"type":20},820,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Gastric\u002FGEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric\u002FGEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric\u002FGEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.",[26,27,28],"Gastric Cancer","Gastroesophageal-junction Cancer","Advanced Cancer","NOT_YET_RECRUITING","2026-09-28",{"date":32,"type":33},"2026-09-29","ACTUAL",{"date":35,"type":20},"2027-06-30",{"date":37,"type":20},"2030-01-31",{"name":39,"class":40},"Transcenta Therapeutics (Hangzhou) Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100655073","phase-2-study-of-tst002-injection-in-postmenopausal-women-with-osteoporosis-or-low-bone-mass-100655073","NCT07806331","Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass","A Randomized, Double-Blind, Parallel-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TST002 Injection in Postmenopausal Osteoporosis Patients and Middle-Aged to Older Women With Low Bone Mass","Inclusion Criteria:\n\n1. Voluntary signed informed consent; able to walk freely; willing\u002Fable to complete all study procedures.\n2. BMI 18.0-30.0 kg\u002Fm² (inclusive); body weight ≥45 kg.\n3. Postmenopausal women aged 45-80 years (inclusive) at screening, postmenopausal ≥2 years (≥12 consecutive months without spontaneous vaginal bleeding\u002Fspotting).\n4. BMD T-score \\\u003C-2.00 at lumbar spine (L1-L4 total), total hip, or femoral neck at screening; OR history of fragility fracture with T-score \\\u003C-1.00 at one of these sites (central imaging read).\n5. At least 2 contiguous evaluable vertebrae (L1-L4) and at least one evaluable hip for DXA assessment.\n6. No disease, per investigator history\u002Fexam\u002Fworkup, likely to significantly affect the study or increase health risk (documented exceptions permitted with justification).\n\nExclusion Criteria:\n\n1. BMD T-score ≤-3.50 at lumbar spine, total hip, or femoral neck at screening.\n2. Prior hip fracture.\n3. ≥2 vertebral fractures on screening lateral spine X-ray (investigator-assessed).\n4. Known skeletal, endocrine, or rheumatic disease that could confound results (e.g., Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta, sclerosteosis, rheumatoid arthritis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, uncontrolled thyroid disease, hyper-\u002Fhypoparathyroidism, or CN VIII compression hearing loss).\n5. Prior osteoporosis therapy (incl. trial participation) within protocol-specified washout windows (IV bisphosphonates, oral bisphosphonates, denosumab\u002Fcathepsin K inhibitors, tibolone\u002Fcinacalcet\u002Fcalcitonin, teriparatide\u002FPTH analogs, systemic estrogen\u002FSERMs, strontium ranelate\u002Ffluoride, hormonal castration therapy, systemic glucocorticoids ≥5 mg\u002Fday prednisone-equivalent for \\>14 days) - see protocol for exact windows per agent.\n6. History of TMJ disorder, TMJ osteonecrosis, or atypical fracture.\n7. Hypercalcemia or hypocalcemia (albumin-corrected) at screening.\n8. Serum 25(OH)D \\\u003C20 ng\u002FmL at screening.\n9. History of MI, or serious cardiac disease (CAD, NYHA class II-IV heart failure) within 6 months before screening.\n10. History of stroke (cerebral infarction, ischemic or hemorrhagic).\n11. ALT\u002FAST \\>3× ULN; ALP \\>2.5× ULN; total bilirubin or creatinine \\>1.5× ULN at screening.\n12. Multiple myeloma, primary\u002Fmetastatic bone malignancy, or history of skeletal radiotherapy.\n13. Malignancy within 5 years before screening (except cured skin squamous\u002Fbasal cell carcinoma or documented cured in situ cervical cancer, no recurrence ≥3 months before dosing).\n14. Known hypersensitivity to study drug.\n15. History of solid organ or bone marrow transplant.\n16. Positive HIV, syphilis, HCV antibody, or HBsAg at screening; or HBcAb-positive with detectable HBV DNA.\n17. Active tuberculosis within 6 months before screening.\n18. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product (whichever longer) before screening.\n19. Any other condition the investigator judges unsuitable for participation, a safety risk, or interfering with study assessments\u002Fcompletion.","FEMALE","45 Years","80 Years",{"count":52,"type":20},110,[54],"PHASE2","This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone mass, aged 45-80 years.\n\nApproximately 110 participants will be randomized 1:1:1:1:1 (stratified by baseline BMD T-score) to one of five arms: TST002 400 mg every 8 weeks (Q8W), TST002 800 mg Q8W, TST002 1200 mg every 12 weeks (Q12W), placebo, or open-label denosumab 60 mg subcutaneously every 24 weeks. The study includes a screening period (Day -28 to Day -1), a main study period (Week 0-24), and an extension period (Week 25-52), with all participants followed through Week 52 (Day 365).\n\nThe primary objective is to evaluate the effect of repeated IV TST002 infusions on lumbar spine bone mineral density (BMD). Secondary objectives include characterization of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability.",[57,58],"Postmenopausal Osteoporosis","Low Bone Mass",[60,61,62,63,64,65,66],"TST002","bone mineral density","postmenopausal osteoporosis","low bone mass","sclerostin","monoclonal antibody","DXA","2026-09-08",{"date":69,"type":33},"2026-09-11",{"date":71,"type":20},"2026-10-31",{"date":73,"type":20},"2028-10-31",{"name":39,"class":40},""]