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

Trial Status: Active

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 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 budigalimab (ABBV-181) combination escalation and expansion cohort.

Inclusion Criteria

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

Exclusion Criteria

  • 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.
  • Body weight less than 35 kilograms.
  • Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD requiring treatment with steroids.
  • Participants previously treated with an anti PD-1/PD-L1 targeting agent must meet additional criteria described in the protocol.
  • Participant 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.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Francisco Robert
Phone: 205-934-5077

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: APPROVED

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Wei-Chu Victoria Lai
Phone: 646-608-3793

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: APPROVED

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: APPROVED

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Abbvie

  • Primary ID M17-327
  • Secondary IDs NCI-2018-02556
  • Clinicaltrials.gov ID NCT03639194