KN035 for dMMR/MSI-H Advanced Solid Tumors

Recruiting now · Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT03667170

Run by

3D Medicines (Sichuan) Co., Ltd.

People needed

200

Starts

2018-08-22

Expected to finish

2026-12-30

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Peking University Cancer Hospital, Peking University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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