Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
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.
Detailed Description
Later-line therapies after failure of standard treatments for advanced colorectal and non-colorectal cancer patients are limited. Mismatch repair (MMR) deficiency or microsatellite instability-high (MSI-H) played a role of positive predictive factor, which had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1 blockade monotherapy in patients with advanced colorectal and non-colorectal cancers.
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. For other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Subjects with MSI-H/dMMR
patients receive 600 mg of the KN035 Subcutaneously every 3 weeks
Intervention: KN035 (Biological)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor
Secondary Outcomes
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- ORR(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)