KN035 for dMMR/MSI-H Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667170
• Other study ID #: KN035-CN-006
• Status: Recruiting
• Phase: Phase 2
• Start date: August 22, 2018
• Est. completion date: December 15, 2025

Study information

• Verified date: January 2024
• Source: 3D Medicines
• Contact: Lin Shen, MD
• Phone: 86-10-88196340
• Email: doctorshenlin[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 15, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• KN035
subcutaneous injection

Locations

Country	Name	City	State
China	Peking University Cancer Hospital, Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
3D Medicines (Sichuan) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by investigator	Up to approximately 2 years
Secondary	Disease Control Rate (DCR)	per RECIST 1.1 assessed by central imaging vendor and investigator	Up to approximately 2 years
Secondary	Duration of Response (DOR)	per RECIST 1.1 assessed by central imaging vendor and investigator	Up to approximately 2 years
Secondary	Progression-Free Survival (PFS)	per RECIST 1.1 assessed by central imaging vedor and investigator	Up to approximately 2 years
Secondary	Overall Survival (OS)	Calculated by the Kaplan-Meier method.	Up to approximately 2 years