NCT03248843

A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors

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 Japanese Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in Japanese patients with advanced and metastatic solid tumor. The dose escalation will follow the widely used 3+3 design.

Detailed description

This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in Japanese patients with advanced and metastatic solid tumor. The dose escalation will follow the widely used 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1.0, 2.5, 5.0 and 10 mg/kg weekly. 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. The enrolled patients are managed under hospitalization for DLT observation period (C1 28 days). If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD, and the previous lower (tolerated) dose level will be considered the MTD if ≤ 1 in 6 subjects has a DLT. A subject who withdraws from the study during Cycle 1 for reasons other than a DLT will be replaced. Subjects will be monitored for safety and efficacy throughout the study. After radiological tumor assessment at Screening, the first radiological assessment of tumor response status will be performed at Week 12 (± 1 week), unless there is clinical indication warranting earlier radiologic imaging. The same imaging technique used at baseline has to be used throughout the study.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	KN035	Four cohorts dosed at 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, and 10 mg/kg weekly. All cohorts are administered by subcutaneous injection (SC).

Timeline

• Start date: 2017-09-15
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2017-08-14
• Last updated: 2022-02-08

Locations

2 sites across 1 country: Japan