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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KN035
Biological/Vaccinesubcutaneous injection
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Subjects with MSI-H/dMMRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor
Time frame
Up to approximately 2 yearsSecondary outcomes
1
ORR
per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by investigator
Time frame
Up to approximately 2 years2
Disease Control Rate (DCR)
per RECIST 1.1 assessed by central imaging vendor and investigator
Time frame
Up to approximately 2 years3
Duration of Response (DOR)
per RECIST 1.1 assessed by central imaging vendor and investigator
Time frame
Up to approximately 2 years4
Progression-Free Survival (PFS)
per RECIST 1.1 assessed by central imaging vedor and investigator
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov