HLX301: This phase I/II study is seeking to determine the appropriate dose level, safety and effectiveness of a new cancer treatment (HLX301) in people with locally advanced or metastatic solid cancersA Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients With Locally Advanced or Metastatic Solid Tumors

Exclusion

• 1. Received prior anti-TIGIT therapy.
• 2. Patients who still have persistent ≥ grade 2 toxicities from prior therapies.

• 3. Concurrent unstable or uncontrolled medical conditions including, but not limited to, the following:

  1. Ongoing or active systemic infections requiring antibiotic treatment
  2. Clinically significant arrhythmia, unstable angina pectoris, class III or IV congestive heart failure as per the New York Heart Association, or acute myocardial infarction in the past 6 months
  3. Unhealed wound or ulcers persisting ≥ 3 months
  4. Psychiatric illness or a social situation that would preclude study compliance
  5. Any other diseases, metabolic dysfunction, physical examination findings, or laboratory results raising reasonable suspicion of a disease or condition that contraindicates use of the investigational drug, that may affect interpretation of results, or that may place the patient at high risk of treatment complications.
• 4. Active CNS metastasis indicated by clinical symptoms, cerebral edema, steroid requirements (not including maintenance low dose steroids), or progressive growth.
• 5. History of any secondary malignancy in the past 3 years with the exception of curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ.
• 6. Active or a history of (in the past 2 years) of autoimmune disease or syndrome requiring systemic steroid or immunosuppressive agents.
• 7. History of interstitial lung disease.
• 8. Hepatitis B virus infection (HBsAg or anti-HBc positive, and HBV-DNA positive), hepatitis C virus infection (anti-HCV positive, and HCV-RNA positive), or co-infection with hepatitis B and hepatitis C (positive HBsAg or anti-HBc, and positive anti-HCV).
• 9. Human immunodeficiency virus (HIV) infection.
• 10. Major surgery, treatment with anti-cancer or investigational agents, or radiotherapy in the 28 days prior to the first study dosing.
• 11. Treatment with immune check point inhibitors (anti-PD-1 or anti-PD-L1) in the 42 days prior to the first study dosing.
• 12. Pregnancy or breast-feeding.
• 13. Patients of reproductive age who are unable to use effective contraceptive measures in the period from the first dose of study drug to 180 days following the last dose of study drug. Female patients who have been amenorrheic for at least 12 months, have had a hysterectomy or oophorectomy, or have been surgically sterilized do not require contraception.