NCT02407990

Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors

A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in participants with advanced tumors.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BGB-A317	In the dose escalation part, the dose levels were escalated following a modified 3+3 dose escalation scheme. In the scheduled exploration part, participants were assigned to doses and dose schedules. In the fixed dose exploration part, participants were assigned to dose group(s) not to exceed the maximum tolerated dose. In the dose expansion part, participants were assigned to different groups based on their tumor type.
BIOLOGICAL	BGB-A317	Participants were assigned to different groups based on their tumor types

Timeline

• Start date: 2015-06-02
• Primary completion: 2020-08-12
• Completion: 2020-08-12
• First posted: 2015-04-03
• Last updated: 2021-11-17
• Results posted: 2021-11-17

Locations

27 sites across 5 countries: United States, Australia, New Zealand, South Korea, Taiwan

Regulatory

• FDA-regulated drug study