KN035 for dMMR/MSI-H Advanced Solid Tumors

NCT03667170 | Recruiting Phase 2 DMC

• 1 other identifier: KN035-CN-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

MSI-H; dMMR; Colorectal cancer; Non-Colorectal Cancers

Outcome Measures

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

  Up to approximately 2 years

Secondary Outcomes (5)

• ORR

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (1)

Subjects with MSI-H/dMMR

EXPERIMENTAL

patients receive 600 mg of the KN035 Subcutaneously every 3 weeks

Biological: KN035

Interventions

KN035 BIOLOGICAL

subcutaneous injection

Subjects with MSI-H/dMMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3D Medicines (Sichuan) Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital, Peking University

Beijing, Beijing Municipality, 100010, China

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

envafolimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lin Shen, MD

  Peking Universtiy Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, MD

CONTACT

86-10-88196340; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: August 22, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)