Clinical trial · Interventional
KN035 for dMMR/MSI-H Advanced Solid Tumors
Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KN035 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects with MSI-H/dMMR
- description
- patients receive 600 mg of the KN035 Subcutaneously every 3 weeks
- interventionNames
- Biological: KN035
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 2 years
- description
- per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor
Secondary outcomes (5)
- measure
- ORR
- timeFrame
- Up to approximately 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDCui C, Wang J, Wang C, Xu T, Qin L, Xiao S, Gong J, Song L, Liu D. Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2024 Sep 6;29(9):e1189-e1200. doi: 10.1093/oncolo/oyae102. PMID 38982653
- DERIVEDLi J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, Lu H, Gong J, Xu T, Liu D, Shen L. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021 Jun 21;14(1):95. doi: 10.1186/s13045-021-01095-1. PMID 34154614