[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620535":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":19,"enrollmentInfo":37,"targetDuration":19,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":19,"overallStatus":50,"whyStopped":19,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":19},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS5316","EXPERIMENTAL","patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol",[13],"Drug: QLS5316",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Varying doses of QLS5316",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Shengxiang Ren, MD","CONTACT","021-65115006-3051","harry_ren@126.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100620535","phase-1-first-in-human-study-of-qls5316-in-solid-tumors-100620535",false,"NCT07358884","First in Human Study of QLS5316 in Solid Tumors","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n3. Life expectancy ≥ 3 months;\n4. Measurable disease per RECIST v1.1\n5. Adequate organ and marrow function as defined in the protocol\n6. Dose escalation and PK expansion stages: Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, who have failed SOC or SOC is not available\n7. Cohort expansion stage: Patients with histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, including CRC, GC\u002FGEJ, HNSCC (mouth, oropharynx, hypopharynx or larynx), EGFR-sensitive mutant NSCLC and EGFR wild-type NSCLC or other advanced malignant solid tumors who have failed SOC or SOC is not available.\n\nExclusion Criteria:\n\n1. Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and\u002For c-MET targeted ADCs\n2. Untreated or active brain metastasis\n3. Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy\n4. Patients with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia, or patients whose suspected ILD\u002Fnon-infectious pneumonia cannot be ruled out by imaging examination at screening; patients with radiation pneumonitis who do not require steroid treatment are allowed to be enrolled;\n5. Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur\n6. Patients with a history of severe cardiovascular and cardiovascular diseases\n7. Clinically uncontrollable third space effusion\n8. Presence of persistent uncontrolled systemic bacterial, fungal or viral infections or severe infections within 4 weeks before the first dose in the study, or active infections requiring systematic antibiotic treatment within 1 week before the first dose in the study;\n9. Known hypersensitivity reactions or delayed-type sensitization to some components or analogues of the investigational drug","ALL","18 Years",{"count":38,"type":39},300,"ESTIMATED","INTERVENTIONAL",[42],"PHASE1","This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.",[45,46,47,48,49],"Solid Tumors","Colorectal Cancer","Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-13",{"date":53,"type":54},"2026-01-22","ACTUAL",{"date":56,"type":39},"2026-01",{"date":58,"type":39},"2027-12",{"name":5,"class":6}]