Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion

Description

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.

Official Title

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

Keywords

Small Cell Lung Cancer, Cancer, Small Cell Lung Carcinoma, Lung Neoplasms, ABBV-011, Budigalimab, ABBV-011 + Budigalimab Escalation and Expansion

Eligibility

Locations

  • University of California, Davis Comprehensive Cancer Center /ID# 207548
    Sacramento California 95817 United States
  • University of Utah /ID# 207553
    Salt Lake City Utah 84112-5500 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
AbbVie
ID
NCT03639194
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 132 people participating
Last Updated