NCT03667170 KN035 for dMMR/MSI-H Advanced Solid Tumors
| NCT ID | NCT03667170 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | 3D Medicines (Sichuan) Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-08-22 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2018-08-22 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: * 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.
Contact & Investigator
Lin Shen, MD
PRINCIPAL INVESTIGATOR
Peking Universtiy Cancer Hospital
Frequently Asked Questions
Who can join the NCT03667170 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03667170 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03667170 currently recruiting?
Yes, NCT03667170 is actively recruiting participants. Contact the research team at doctorshenlin@sina.cn for enrollment information.
Where is the NCT03667170 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT03667170 clinical trial?
NCT03667170 is sponsored by 3D Medicines (Sichuan) Co., Ltd.. The principal investigator is Lin Shen, MD at Peking Universtiy Cancer Hospital. The trial plans to enroll 200 participants.