Program Status
RecruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesTags
MSI-H/ MMRdComments
Trial in China, that admits only patients with MSI-H/MMRd CRC cancer (not MSS), who have been previously treated with standard therapies or refuse standard therapy.
They will receive KN035 as a subcutaneous injection, twice per week.
No prior checkpoint inhibitor immunotherapy allowed.
KN035 (envafolimab): single-domain anti-PD-L1 monoclonal antibody
Helpful Links
https://pubmed.ncbi.nlm.nih.gov/35932387/Location | Location Status |
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China | |
Peking University Cancer Hospital, Peking University Beijing, Beijing 100010 |
Recruiting |
Contacts
Inclusion Criteria
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
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.