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Recruiting NCT03667170

KN035 for dMMR/MSI-H Advanced Solid Tumors

Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KN035.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors

Overview

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.

Interventions

  • Biological KN035
    subcutaneous injection

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (5)
  • ORR [Time frame: Up to approximately 2 years]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 2 years]
  • Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Cancer Hospital, Peking University — Beijing

Publications

  • Cui 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
  • Li 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

Identifiers

NCT: NCT03667170 · KN035-CN-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗