KN035 for dMMR/MSI-H Advanced Solid Tumors

Prior treatment

• Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study.
• Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
• Has received prior therapy with an immune check point agonist/inhibitor.
• Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
• Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study.

Other illness

• Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
• Active autoimmune disease that has required systemic treatment.
• Patients who have known history of infection with HIV.
• Patients with evidence of interstitial lung disease.
• Patients who have known history of any major cardiac abnormalities.

Other

• Known active central nervous system metastases and/or carcinomatous meningitis.
• Patient who is not willing to apply highly effective contraception during the study.

• Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
• Confirmed MMR deficient or MSI-H status.
• At least one measureable lesion.
• Eastern Cooperative Oncology Group performance status of 0 or 1 .
• Life expectancy of greater than 12 weeks.
• Adequate hematologic and organ function.