NCT03639194

A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ABBV-011	Intravenous
DRUG	Budigalimab	Intravenous

Timeline

• Start date: 2018-10-24
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2018-08-21
• Last updated: 2024-02-09

Locations

32 sites across 4 countries: United States, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study