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.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Life expectancy ≥ 3 months;
Measurable disease per RECIST v1.1
Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and/or c-MET targeted ADCs
Untreated or active brain metastasis
Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy
Patients with a history of interstitial lung disease (ILD)/non-infectious pneumonia, or patients whose suspected ILD/non-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;
Single group
QLS5316
DrugVarying doses of QLS5316
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
To evaluate the safety and tolerability of QLS5316
Number of Participants With Clinical Laboratory Test Abnormalities
Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.
12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)
Assessment of abnormal electrocardiogram parameters before and after treatment
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.
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