A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody

Inclusion Criteria:

• Male or female patients ≥18 years old at the time of signing the informed consent and ≤ 75 years old at the time of enrollment.
• Patients for Part 1a: patients diagnosed with advanced or recurrent solid tumors.
• Patients for Part 1b: patients diagnosed with metastatic NSCLC and confirmed with negative tumor PD-L1 expression (TPS<1%).
• Patients for Part 1b dose expansion study: have never received systemic therapies as primary therapy for advanced or metastatic diseases.
• Patients must be able to provide fresh tumor tissues or archived tumor tissues.
• Patients whose estimated survival time is more than 3 months.
• Patients with at least one measurable lesion at baseline according to RECIST (version 1.1).
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• Patients whose organ function must meet the study requirements.
• Males or females with childbearing potential need to use an effective contraceptive method.
• Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.

Exclusion Criteria:

• NSCLC patients with EGFR-sensitive mutations or an ALK translocation based on diagnosis results.
• Patients who are simultaneously participating in another clinical study, unless the study is an observational (non-interventional) clinical study or the patient is already in the survival follow-up period of the interventional study.
• Patients with a medical history of severe allergic diseases, a history of severe drug allergies, and are known or suspected allergy to macromolecular protein preparations or HBM4003 or pembrolizumab excipients.
• Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
• Insufficient completely recovery from previous treatments.
• Diseases that may affect the efficacy and safety of the investigational product.
• A history of other malignant diseases within 5 years before the first dose.
• Active brain metastasis or leptomeningeal metastasis during screening or previous with imaging evidence (based on CT or MRI assessment).
• Patients who have received palliative radiotherapy for non-central nervous system lesions within 2 weeks before the first dose.
• Patients who have received more than 30 Gy of lung radiation therapy within 6 months before the first dose.
• A history of interstitial lung disease or non-infectious pneumonia.
• Patients with pleural effusion, pericardial effusion, or ascites.
• Patients that may have other conditions that affect the efficacy or safety evaluation of this study (such as mental disorder, alcoholism, drug abuse, etc.) .
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last dose of study drug.