KN035 for dMMR/MSI-H Advanced Solid Tumors

NCT ID: NCT03667170

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2026-12-15

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.

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with MSI-H/dMMR

patients receive 600 mg of the KN035 Subcutaneously every 3 weeks

Group Type: EXPERIMENTAL

KN035

Intervention Type: BIOLOGICAL

subcutaneous injection

Interventions

KN035

subcutaneous injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines (Sichuan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Universtiy Cancer Hospital

Locations

Peking University Cancer Hospital, Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Shen, MD

Role: CONTACT

doctorshenlin@sina.cn

86-10-88196340

Facility Contacts

Lin Shen, MD

Role: primary

doctorshenlin@sina.cn

86-010-88196340

References

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.

Reference Type: DERIVED

PMID: 38982653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34154614 (View on PubMed)

Other Identifiers

KN035-CN-006

Identifier Type: -

Identifier Source: org_study_id