A Study of SC-011 Alone and in Combination With ABBV-181 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Status: Active

Description

This is a multicenter, open-label, Phase 1 study of SC-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 SC-011 dose-finding regimen cohort; followed by Part B, a single-agent SC-011 dose expansion cohort; and then Part C, an SC-011 and ABBV-181 combination escalation and expansion cohort.

Eligibility Criteria

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.

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.
  • 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 & Contacts

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: In review
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

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