KN035 for dMMR/MSI-H Advanced Solid Tumors
About this study
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.
- Condition
- Solid Tumor
- Tested
- KN035
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Solid Tumor
- 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 12
- 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.
Where
1 site, 1 recruiting
Peking University Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
Contact
-
Lin Shen, MD
86-10-88196340 doctorshenlin@sina.cn
Potential match only. Final eligibility is determined by the study team.