Spots Global Cancer Trial Database for Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors

Official Title: A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors

Study ID: NCT02827968

Conditions

Solid Tumors

Interventions

KN035

Study Description

Brief Summary: This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor.

Detailed Description: The dose escalation will follow the traditional 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. Dosing schedule for cohorts 2 and above may change after interim PK analysis after Cohort 1 Cycle 1 to bi-weekly or other regimen based on elimination profile of KN035 to avoid excessive drug accumulation. Dose escalation will continue until identification of MTD, up to a maximum dose of 10 mg/kg. MTD is defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose-limiting toxicity (DLT) in Cycle 1.