A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors

Inclusion criteria

• Those who are able to understand and willing to sign written Informed Consent Form.
• Aged between 18 and 75 years (inclusive) when signing the ICF
• Participants with advanced solid tumors
• The participant agrees to provide fresh biopsy or archived tumor tissues for testing by the central laboratory.
• At least one evaluable lesion in the dose-escalation part, and at least one measurable lesion in the dose-expansion part.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥ 3 months.
• Adequate hematologic and organ function before the first dose of GenSci140.
• All toxicities related to prior anti-tumor therapies must have resolved to Grade ≤ 1, with the following exceptions: alopecia, peripheral neurotoxicity (must have resolved to Grade ≤ 2).
• For participants with congestive heart failure (CHF), it must be Grade ≤ 1 in severity and must have recovered completely prior to enrollment.
• Normal QT interval on electrocardiogram (ECG) evaluation at screening
• Participants who test negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. WOCBP must agree to avoid pregnancy.
• Men with female partners of childbearing potential must take appropriate precautions to avoid pregnancy of partner and use appropriate barrier contraceptives or abstinence

Exclusion criteria

• Past history of cancers.
• Symptomatic primary central nervous system (CNS) tumors, metastases, leptomeningeal carcinomatosis, or therapy naive spinal cord compression.
• Use of an investigational medicinal product (IMP) or antitumor therapy (including chemotherapy, biologic therapy, immunotherapy) within 5 half-lives or 4 weeks before the first dose of GenSci140. Concomitant anti-tumor therapy is not permitted
• Major surgery within 4 weeks prior to the first dose of GenSci140.
• Radiotherapy for ≥ 20% of bone marrow or large area of radiotherapy within 4 weeks prior to the first dose of GenSci140. Or participants have not recovered from acute effects of radiotherapy to baseline prior to the first dose of GenSci140.
• Clinically significant active cardiovascular disorder or history of myocardial infarction within 6 months prior to the first dose of GenSci140.
• Uncontrolled active systemic bacterial, viral, or fungal infection or ongoing serious systemic disease, such as hypertension or diabetes, despite Best Supportive Care. Chronic disease screening is not required.
• History of multiple sclerosis or other demyelinating diseases, Eaton-Lambert syndrome (paraneoplastic syndrome), alcoholic liver disease, history of internal haemorrhage or ischemic stroke within the past 6 months, haemorrhagic diathesis that are unsuitable for enrollment as assessed by the investigator.
• Suspected treatment-related pneumonitis that was clinically diagnosed in the past and currently requires steroids or cannot be ruled out by imaging at screening.
• Uncontrolled pleural effusion, pericardial effusion, or abdominal and pelvic fluid collection requiring drainage and/or diuretics within 14 days prior to the first dose of GenSci140.
• Pregnant or lactating women.
• Known hypersensitivity to prior monoclonal antibody therapy.
• Patients who previously underwent allogeneic or autologous bone marrow transplantation.
• Participants whom the investigator deems unsuitable for enrollment in this clinical study