A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors

Prior treatment

• Treatment with any of the following:
  • Having received cytotoxic chemotherapy agents, investigational drugs, Chinese medicine treatment with anti-tumor indications, or other anti-tumor therapy (including endocrine therapy, molecular targeted therapy, or biotherapy) within 14 days before the first dose of study treatment.
  • Having received macromolecular anti-tumor drug therapy (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs) within 28 days before the first dose of study treatment.
  • Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.

Other illness

• Active autoimmune diseases or active infectious disease
• History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108
• History of neuropathy or mental disorders, including epilepsy and dementia.

Other

• Inadequate bone marrow reserve or serious organ dysfunction.
• Uncontrolled pleural effusion or ascites or pericardial effusion.
• Known and untreated, or active central nervous system metastases.
• Known to have interstitial pneumonia or immune pneumonia
• The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
• The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
• Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.

• Men or women aged more than or equal to (≥) 18 years.
• Participants with pathologically confirmed advanced solid tumors.
• At least one measurable lesion in accordance with RECIST 1.1
• Fresh or archival tumor tissue available for submission.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
• Estimated life expectancy \>12 weeks.
• Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
• Females must have evidence of non-childbearing potential.
• Signed and dated Informed Consent Form.