KN035 for dMMR/MSI-H Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor3D Medicines (Sichuan) Co., Ltd.
About this trial
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
Qualifiers
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 .
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KN035
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov