NCT03101488

Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

A Phase I, Single Arm, Multiple Dose, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KN035 Administered in Subcutaneous Injection as a Single Agent to Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This dose escalation and dose expansion study is to evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adult subjects with unresectable advanced carcinoma.

Detailed description

Dose escalation study is to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor. Six dose levels are planned and include: 0.1, 0.3, 1.0, 2.5, 5, 10 mg/kg/dose. Subjects will be assigned to a dose level in the order of study entry. The first cohort of 1 subject will receive KN035 at 0.1 mg/kg/dose as a subcutaneous (sc) injection every week for a total of 4 injections (Days 1, 8, 15 and 22) in the first 28-day cycle. For the first 2 cohorts (0.1 and 0.3 mg/kg/dose), only one subject will be enrolled in each cohort until 1 subject experiences a ≥ Grade 2 drug-related adverse event in the first cycle, then 2 additional subjects will be enrolled at this cohort. Thereafter, the study will become the traditional 3+3 design with 3 or 6 subjects treated at this dose level and all subsequent dose levels depending upon the incidence of DLTs. However, if no ≥ Grade 2 drug-related adverse event occurs in the first 2 cohorts, starting with cohort 3, the study will become the traditional 3+3 design with 3 or 6 subjects enrolled. Dose expansion-1 study is planned to conduct in advanced hepatocellular cancer subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively. Dose expansion-2 study is planned to conduct in advanced solid tumor subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	KN035	KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.

Timeline

• Start date: 2017-03-21
• Primary completion: 2019-09-02
• Completion: 2020-08-25
• First posted: 2017-04-05
• Last updated: 2022-03-03

Locations

4 sites across 1 country: China