Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors

KN035-CN-006

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy. For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

2018-08-22

2024-06-30

2025-12-15

Recruiting

Early phase I

200

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Has a known additional malignancy that is progressing or requires active treatment within the past 5 years. * Known active central nervous system metastases and/or carcinomatous meningitis. * 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. * Patient who is not willing to apply highly effective contraception during the study. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-01-31