KN035 for dMMR/MSI-H Advanced Solid Tumors

Summary

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.

Eligibility

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.

Conditions2

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