[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620535":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":51,"overallOfficials":37,"centralContacts":56,"locations":37,"responsibleParty":62,"collaborators":37,"id":64,"slug":37,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":37,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":37,"enrollmentInfo":72,"targetDuration":37,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":37,"overallStatus":85,"whyStopped":37,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":37},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":37},[9,13,16,19,22,25,29,33],{"measure":10,"description":11,"timeFrame":12},"Number of participants with adverse events as assessed by NCI-CTCAE v5.0","To evaluate the safety and tolerability of QLS5316","From time of Informed Consent to 30 days post last dose of QLS5316",{"measure":14,"description":15,"timeFrame":12},"Number of Participants With Clinical Laboratory Test Abnormalities","Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.",{"measure":17,"description":18,"timeFrame":12},"12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)","Assessment of abnormal electrocardiogram parameters before and after treatment",{"measure":20,"description":21,"timeFrame":12},"Number of participants with physical examination abnormalities","Including general conditions, skin and mucosa, systemic superficial lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system, and other examinations.",{"measure":23,"description":24,"timeFrame":12},"Number of participants with vital signs abnormalities","Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation",{"measure":26,"description":27,"timeFrame":28},"DLT","Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Protocol","From time of first dose of QLS5316 to end of DLT period (21 days)",{"measure":30,"description":31,"timeFrame":32},"MTD","the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy","1 year",{"measure":34,"description":35,"timeFrame":36},"RP2D","the recommended phase II dose of QLS5316 monotherapy","2 year",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"QLS5316","EXPERIMENTAL","patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol",[50],"Drug: QLS5316",[52],{"type":53,"name":46,"description":54,"armGroupLabels":55,"otherNames":37},"DRUG","Varying doses of QLS5316",[46],[57],{"name":58,"role":59,"phone":60,"phoneExt":37,"email":61},"Shengxiang Ren, MD","CONTACT","021-65115006-3051","harry_ren@126.com",{"type":63,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":73,"type":74},300,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80,81,82,83,84],"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":88,"type":89},"2026-01-22","ACTUAL",{"date":91,"type":74},"2026-01",{"date":93,"type":74},"2027-12",{"name":5,"class":6}]