KN035 for dMMR/MSI-H Advanced Solid Tumors

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Tags

MSI-H/ MMRd

Comments

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

Location Location Status
China
Peking University Cancer Hospital, Peking University
Beijing, Beijing 100010
Recruiting

Contacts

Lin Shen, MD
CONTACT
86-10-88196340 doctorshenlin@sina.cn

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.

NCT ID

NCT03667170

Date Trial Added

2018-09-12

Updated Date

2024-08-23