At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 200 target
Drug / intervention
KN035biological
Likely dose
Not stated in record
Key inclusion· 6
- ✓Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors
- ✓MMR deficient or MSI-H status confirmed
- ✓At least one measurable lesion
- ✓ECOG performance status 0 or 1
Key exclusion· 12
- ✕Investigational agent or device within 4 weeks, or anti-tumor treatment within 2 weeks
- ✕Not recovered to CTCAE Grade 1 or better from prior therapy side effects
- ✕Prior immune checkpoint agonist/inhibitor therapy
- ✕Major surgery within 4 weeks of dosing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors
In Brief
A Phase 2 clinical trial evaluating KN035 for Solid Tumor. Currently recruiting, targeting 200 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
201920202021202220232024202520262027
Enrollment StartAug 2018
First PostedSep 2018
TodayJul 2026
Primary CompletionDec 2026
First PostedSep 12, 2018
Enrollment StartAug 22, 2018
Primary CompletionDec 30, 2026
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 7.8 years agoPrimary completion in 6 months
Interventions
KN035biological
subcutaneous injection