[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660228":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":23,"interventions":30,"overallOfficials":11,"centralContacts":11,"locations":35,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Shandong Boan Biotechnology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs) , immune-related AEs(irAEs), infusion-related reactions (IRRs), AEs of special interest (AESIs)",null,"Through 28 days after the last study treatment",{"measure":14,"description":11,"timeFrame":12},"Incidence and severity of dose limiting toxicities in each dose cohort, and maximum tolerated dose",{"measure":16,"description":11,"timeFrame":12},"Recommended phase 2 dose of BA1203",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"NA","SINGLE_GROUP","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE",[24],{"label":25,"type":26,"description":27,"interventionNames":28},"BA1203","EXPERIMENTAL","Participants will receive BA1203 once every 2 weeks (Q2W), until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years.",[29],"Drug: BA1203",[31],{"type":32,"name":25,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","intravenous (IV) once every 2 weeks (Q2W).",[25],[36],{"facility":37,"status":38,"city":39,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Jie Wang","CONTACT","8610-87788525","zlhuxi@163.com",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100660228","phase-1-a-trial-to-evaluate-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-ba1203-in-advanced-solid-tumors-100660228",false,"NCT07876609","A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.","A Multicenter, Open-Label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BA1203 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol;\n2. Subject with histologically or cytologically confirmed advanced and\u002For metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and\u002For are non-amenable to SOC;\n3. At least one measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1);\n4. Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior Programmed Death-Ligand 1 (PD-L1) histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.;\n5. Life expectancy \\>=12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. Adequate major organ function;\n8. Women of Childbearing Potential must have a negative pregnancy test within 7 days prior to the first dose: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods;\n9. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Patients with primary central nervous system tumors or new or symptomatic central nervous system metastases.\n2. Patients with a known history of another malignancy within 5 years prior to signing the informed consent.\n3. Patients with significant cardiovascular and cerebrovascular diseases.\n4. Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis\u002Fproctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome.\n5. Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive therapy.\n6. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity syndrome (DIHS).\n7. History of allogeneic hematopoietic stem cell transplantation or organ transplantation, or currently awaiting transplantation.\n8. Immune-related adverse events during prior antitumor therapy that make the patient no longer suitable for continued immunotherapy.\n9. Prior treatment with Programmed Cell Death Protein 1 \u002F Interleukin-2 or Programmed Cell Death Protein 1 \u002F Interleukin-15 agents.","ALL","18 Years","75 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1203 in participants with advanced solid tumors.",[74],"Solid Tumors","2026-10-14",{"date":77,"type":78},"2026-10-19","ACTUAL",{"date":80,"type":68},"2026-10-30",{"date":82,"type":68},"2030-12-31",{"name":5,"class":6},1]