KN035 for dMMR/MSI-H Advanced Solid Tumors

Phase 2

Recruiting

• Conditions: Solid Tumor

• Registration Number: NCT03667170
• Lead Sponsor: 3D Medicines (Sichuan) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-9-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Histologically confirmed locally advanced or metastatic colorectal carcinoma or<br> other malignant solid tumors.<br><br> - Confirmed MMR deficient or MSI-H status.<br><br> - At least one measureable lesion.<br><br> - Eastern Cooperative Oncology Group performance status of 0 or 1 .<br><br> - Life expectancy of greater than 12 weeks.<br><br> - Adequate hematologic and organ function.<br><br>Exclusion Criteria:<br><br> - Currently participated in a study of an investigational agent and received trial<br> treatment, or used an investigational device within 4 weeks of the first dose of<br> medication in this study. Patients who have had specific anti-tumor treatment within<br> 2 weeks prior to the first dose of study.<br><br> - Patients who have not recovered to CTCAE Grade 1 or better from related side effects<br> of any prior antineoplastic therapy.<br><br> - Has received prior therapy with an immune check point agonist/inhibitor.<br><br> - Patients who have undergone major surgery within 4 weeks of dosing of<br> investigational agent.<br><br> - Has a known additional malignancy that is progressing or requires active treatment<br> within the past 5 years.<br><br> - Known active central nervous system metastases and/or carcinomatous meningitis.<br><br> - Active autoimmune disease that has required systemic treatment.<br><br> - Patients who have known history of infection with HIV.<br><br> - Patients with evidence of interstitial lung disease.<br><br> - Patients who have known history of any major cardiac abnormalities.<br><br> - Patient who is not willing to apply highly effective contraception during the study.<br><br> - Patients who have other concurrent severe and/or uncontrolled medical conditions<br> that would, in the investigator's judgment, contraindicate patient participation in<br> the clinical study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
ORR;Disease Control Rate (DCR);Duration of Response (DOR);Progression-Free Survival (PFS);Overall Survival (OS)