🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT03667170
Recruiting Phase 2

KN035 for dMMR/MSI-H Advanced Solid Tumors

NCT03667170 · tracked via the Priya Life Science China tracker
Sponsor
3D Medicines (Sichuan) Co., Ltd.
Phase
Phase 2
Started
2018-08-22
Last updated
2026-03-25

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

KN035

KN035: subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital, Peking University Beijing Beijing Municipality Recruiting

More 3D Medicines (Sichuan) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03667170 on ClinicalTrials.gov ↗ ← All trials in China