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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedABBV-011 and Budigalimab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 9, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?32 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Interventions being studied: Drug: ABBV-011; Drug: Budigalimab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing 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 or 1.
Minimum life expectancy of at least 12 weeks.
Recovery to at least Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
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.
Sponsor may elect for confirmed SCLC tumor tissue to test positive for target expression for Parts A and D participants as well.
Last dose of any prior anticancer therapy \>= 4 weeks before the first dose of study drug. Additional Inclusion Criteria for Study Part B and Part C:
SCLC tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC).

Reasons someone may not be able to joinExclusion 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.
Active SARS-CoV-2 infection.
Prior or concomitant malignancies with some exceptions, as described in the protocol.
Any significant medical or psychiatric condition, including any suggested by Screening laboratory findings, that in the opinion of the Investigator or Sponsor may place the participant at undue risk from the study treatment, interfere with interpretation of study results, or compromise ability to comply with protocol requirements.
Participants with a history of hypersensitivity to the active ingredients or any excipients of study drugs (ABBV-011 or budigalimab \[ABBV-181\]) will be excluded. Additional

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at Birmingham - Main /ID# 207295Birmingham, Alabama
Highlands Oncology Group, PA /ID# 207176Springdale, Arkansas
University of California, Davis Comprehensive Cancer Center /ID# 207548Sacramento, California
Yale School of Medicine /ID# 207559New Haven, Connecticut
University of Iowa Hospitals and Clinics /ID# 207560Iowa City, Iowa
University of Kentucky Chandler Medical Center /ID# 208217Lexington, Kentucky
Massachusetts General Hospital /ID# 207549Boston, Massachusetts
Dana-Farber Cancer Institute /ID# 213032Boston, Massachusetts
University of Michigan Comprehensive Cancer Center /ID# 207177Ann Arbor, Michigan
Henry Ford Hospital /ID# 233539Detroit, Michigan
Washington University-School of Medicine /ID# 207168St Louis, Missouri
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216New York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 9, 2024. Always confirm current availability with the study team.

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