KN035 for dMMR/MSI-H Advanced Solid Tumors

Program Status

Clinical trial’s patient recruitment status

Recruiting

Phase

Phase of the clinical trial that is recruiting (I, II, or III)

Phase 2

Prior Immunotherapy Allowed

Whether the clinical trial is open to patients who have received prior immunotherapy

No

CRC-directed Trial

A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients

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

Trial ID number from clinicaltrials.gov or other database

NCT03667170

Date Trial Added

Date on which the clinical trial was added to the clinicaltrials.gov website

2018-09-12

Updated Date

Date on which the clinical trial was updated on the clinicaltrials.gov website

2025-05-29