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KN035 for dMMR/MSI-H Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03667170
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
3D Medicines (Sichuan) Co., Ltd.

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. There will be two cohorts in this study: Cohort 1 and Cohort 2. For Cohort 1, colorectal cancer participants, who are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, or irinotecan. For Cohort 2, other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: KN035 Phase 2

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. There will be two cohorts in this study: Cohort 1 and Cohort 2. For Cohort 1, colorectal cancer participants, who are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, or irinotecan. For Cohort 2, other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: Cohort1: MSI-H Colorectal Cancer
Cohort 1 patients receive KN035 150 mg Subcutaneously on Day 1, 8, 15, 22 of every 4-week cycle (Q4W)
Biological: KN035
subcutaneous injection

Experimental: Cohort2: dMMR Non-Colorectal Cancer
Cohort 1 patients receive KN035 150 mg Subcutaneously on Day 1, 8, 15, 22 of every 4-week cycle (Q4W)
Biological: KN035
subcutaneous injection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. ORR [ Time Frame: Up to approximately 2 years ]
    per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by investigator

  2. Disease Control Rate (DCR) [ Time Frame: Up to approximately 2 years ]
    per RECIST 1.1 assessed by central imaging vendor and investigator

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]
    per RECIST 1.1 assessed by central imaging vendor and investigator

  4. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
    per RECIST 1.1 assessed by central imaging vedor and investigator

  5. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    Calculated by the Kaplan-Meier method.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667170


Contacts
Contact: Lin Shen, MD 86-10-88196340 doctorshenlin@sina.cn

Locations
China, Beijing
Peking University Cancer Hospital, Peking University Recruiting
Beijing, Beijing, China, 100010
Contact: Lin Shen, MD    86-010-88196340    doctorshenlin@sina.cn   
Sponsors and Collaborators
3D Medicines (Sichuan) Co., Ltd.
Investigators
Principal Investigator: Lin Shen, MD Peking Universtiy Cancer Hospital

Responsible Party: 3D Medicines (Sichuan) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03667170     History of Changes
Other Study ID Numbers: KN035-CN-006
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by 3D Medicines (Sichuan) Co., Ltd.:
MSI-H
dMMR
Colorectal cancer
Non-Colorectal Cancers

Additional relevant MeSH terms:
Microsatellite Instability
Genomic Instability
Pathologic Processes