A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

Inclusion Criteria:

• Small cell lung cancer (SCLC), who failed or intolerant to available standardtreatments;

• Tissue sample positive for DLL3 expression;

• Life expectancy ≥ 3 months;

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

• Female and Male patients must agree to use a reliable form of contraception duringthe study treatment period and for at least 6 months after the last dose of thestudy drug.

Exclusion Criteria:

• Patients having received any of the following treatments:

• Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement),and biological targeted medicines ≤ 4 weeks before the study entry. Localpalliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5half-lives, whichever is longer) before the study entry;

• Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the studyentry;

• Use of any vaccines against viral infections (COVID-19, influenza, varicella,etc.) within 4 weeks of study entry;

• Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renalreplacement therapy within 14 days prior to study entry;

• A history of severe, life-threatening immune-mediated adverse events orinfusion-related reactions during previous anti-tumor immunotherapy, includingevents that led to permanent discontinuation of treatment;

• Active infection (such as acute bacterial infection, tuberculosis, active hepatitisB/C, active syphilis, or active human immunodeficiency virus infection);

• Known allergy to other mAbs or any antibody excipients; the history of a severeallergic reaction, anaphylactoid or other hypersensitivity reactions to humanizedantibodies or fusion proteins;

• A female who is pregnant or nursing;

• Patients were deemed unsuitable for participating in the study by the investigatorfor any reason.