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.
- 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.
- 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.
University of Alabama at Birmingham Cancer Center
Contact: Francisco Robert
University of California Davis Comprehensive Cancer Center
University of Iowa / Holden Comprehensive Cancer Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
University of Michigan Comprehensive Cancer Center
Siteman Cancer Center at Washington University
Memorial Sloan Kettering Cancer Center
Contact: Wei-Chu Victoria Lai
Case Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Fred Hutch / University of Washington Cancer Consortium
University of Wisconsin Hospital and Clinics
Trial Phase Phase I
Trial Type Treatment
- Primary ID M17-327
- Secondary IDs NCI-2018-02556
- Clinicaltrials.gov ID NCT03639194