Summary

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

Description

Summary

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with ABBV-181 in subjects with relapsed or refractory small cell lung cancer (SCLC). The study consists of 3 parts: Part A is a single-agent ABBV-011 dose-finding regimen cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and ABBV-181 combination escalation and expansion cohort.

Official Title

A Phase I Study of ABBV-011 as a Single-Agent and in Combination With 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 ABBV-181

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must have histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-based systemic chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available.
  • Measurable disease, defined as at least 1 tumor lesion greater than or equal to 10 mm in the longest diameter or a lymph node greater than or equal to 15 mm in short axis measurement assessed by computed tomography (CT) scan, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate hematologic, hepatic, neurologic, and renal function.

All subjects in Part B and Part C will be required to have tumor tissue that tests positive for target expression.

You CAN'T join if...

  • History of confirmed or suspected liver cirrhosis, hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS), alcohol dependence, or ongoing excessive alcohol use.
  • Prior history of allogeneic or autologous stem cell transplantation.
  • Documented history of stroke or clinically significant cardiac disease as described in the protocol within 6 months prior to the first dose of study drug.
  • History of cardiac conduction abnormalities as described in the protocol.
  • Recent or ongoing serious infection, as described in the protocol.
  • Prior or concomitant malignancies with some exceptions, as described in the protocol.

Additional Exclusion Criteria for Part C:

  • History of inflammatory bowel disease.
  • Peripheral neuropathy Grade 2 with pain, or Grade 3 or higher.
  • Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD requiring treatment with steroids.
  • Creatinine clearance < 50 mL/minute.
  • Subjects previously treated with an anti PD-1/PD-L1 targeting agent must meet additional criteria described in the protocol.
  • Subject is judged by the Investigator to have evidence of ongoing hemolysis.
  • Active autoimmune disease with exceptions as indicated in the protocol.
  • History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.

Locations

  • UC Davis Comp Cancer Ctr /ID# 207548 not yet accepting patients
    Sacramento California 95817 United States
  • University of Utah Huntsman /ID# 207553 not yet accepting patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Sign up for this study
ID
NCT03639194
Phase
Phase 1
Study Type
Interventional
Last Updated