Actively Recruiting
KN035 for dMMR/MSI-H Advanced Solid Tumors
Led by 3D Medicines (Sichuan) Co., Ltd. · Updated on 2026-03-25
200
Participants Needed
1
Research Sites
436 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KN035 for dMMR/MSI-H Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
- Confirmed mismatch repair deficient or microsatellite instability-high status.
- At least one measurable lesion.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy greater than 12 weeks.
- Adequate hematologic and organ function.
You will not qualify if you...
- Currently participating in another investigational study or used an investigational device within 4 weeks prior to study treatment.
- Received specific anti-tumor treatment within 2 weeks before study drug administration.
- Not recovered to CTCAE Grade 1 or better from prior antineoplastic therapy side effects.
- Prior therapy with an immune checkpoint agonist or inhibitor.
- Underwent major surgery within 4 weeks of investigational agent dosing.
- Known additional malignancy progressing or requiring active treatment within the past 5 years.
- Active central nervous system metastases or carcinomatous meningitis.
- Active autoimmune disease requiring systemic treatment.
- Known history of HIV infection.
- Evidence of interstitial lung disease.
- Known major cardiac abnormalities.
- Unwilling to use highly effective contraception during the study.
- Other severe or uncontrolled medical conditions contraindicating study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital, Peking University
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
L
Lin Shen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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