Treatment of advanced solid tumors with KN035

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

This study is testing a new treatment called KN035 for patients with advanced solid tumors that haven't responded to other therapies to see if it can help them.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 3D Medicines (Industry-sponsored)
• Drugs / interventions: pembrolizumab, nivolumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT03667170 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of KN035 monotherapy in patients with previously-treated locally-advanced or metastatic solid tumors that are either mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). Participants must have received prior standard therapies and have measurable lesions. The study aims to provide a new treatment option for patients who have limited options after standard therapies have failed.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced colorectal carcinoma or other solid tumors that are dMMR or MSI-H and have previously undergone standard treatment.

Not a fit: Patients who have not been previously treated with standard therapies or those who have received prior therapy with immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: Previous studies have shown promising results for PD-1 blockade in similar patient populations, indicating potential success for this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital, Peking University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lin Shen, MD — Peking Universtiy Cancer Hospital
• Study coordinator: Lin Shen, MD

Conditions Solid Tumor; MSI-H; dMMR; Colorectal cancer; Non-Colorectal Cancers