KN035 for dMMR/MSI-H Advanced Solid Tumors
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 previou
| Condition(s) | Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | 3D Medicines (Sichuan) Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2018-08-22 |
| NCT ID | NCT03667170 |
| Official listing | https://clinicaltrials.gov/study/NCT03667170 |