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

NCT ID: NCT03639194

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2024-01-25

Brief 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: ABBV-011 Dose Escalation

ABBV-011 via intravenous administration at various doses and dosing regimens until the maximum tolerated dose and/or the recommended Part B dose(s) is declared.

Group Type: EXPERIMENTAL

ABBV-011

Intervention Type: DRUG

Intravenous

Part B: ABBV-011 Dose Expansion

ABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.

Group Type: EXPERIMENTAL

ABBV-011

Intervention Type: DRUG

Intravenous

Part C: ABBV-011 + Budigalimab Escalation and Expansion

ABBV-011 via intravenous administration at various doses and dosing regimens starting at least 1 dose level below the recommended single-agent dose of ABBV-011 for Part B plus Budigalimab via intravenous administration at fixed doses and various dosing regimens.

Group Type: EXPERIMENTAL

ABBV-011

Intervention Type: DRUG

Intravenous

Budigalimab

Intervention Type: DRUG

Intravenous

Part D: ABBV-011 Dose Evaluation for Japan

ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.

Group Type: EXPERIMENTAL

ABBV-011

Intervention Type: DRUG

Intravenous

Interventions

ABBV-011

Intravenous

Intervention Type: DRUG

Budigalimab

Intravenous

Intervention Type: DRUG

Other Intervention Names

SC-011; ABBV-181

Eligibility Criteria

Inclusion 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.

• SCLC tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC).

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.
• 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.

• 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.
• Immunosuppressive use with exceptions as per protocol.
• Participants who have received a live vaccine within 30 days of start of study treatment.
• Active autoimmune disease with exceptions as indicated in the protocol.
• History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
• Participants with a history of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS).

• Participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

University of Alabama at Birmingham - Main /ID# 207295

Birmingham, Alabama, United States

Highlands Oncology Group, PA /ID# 207176

Springdale, Arkansas, United States

University of California, Davis Comprehensive Cancer Center /ID# 207548

Sacramento, California, United States

Yale School of Medicine /ID# 207559

New Haven, Connecticut, United States

University of Iowa Hospitals and Clinics /ID# 207560

Iowa City, Iowa, United States

University of Kentucky Chandler Medical Center /ID# 208217

Lexington, Kentucky, United States

Massachusetts General Hospital /ID# 207549

Boston, Massachusetts, United States

Dana-Farber Cancer Institute /ID# 213032

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center /ID# 207177

Ann Arbor, Michigan, United States

Henry Ford Hospital /ID# 233539

Detroit, Michigan, United States

Washington University-School of Medicine /ID# 207168

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216

New York, New York, United States

Duke Cancer Center /ID# 207547

Durham, North Carolina, United States

UH Cleveland Medical Center /ID# 207561

Cleveland, Ohio, United States

The Ohio State University /ID# 207552

Columbus, Ohio, United States

Tennessee Oncology, PLLC /ID# 207175

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center /ID# 207551

Nashville, Tennessee, United States

NEXT Oncology /ID# 207167

San Antonio, Texas, United States

University of Utah /ID# 207553

Salt Lake City, Utah, United States

University of Washington /ID# 207557

Seattle, Washington, United States

Univ of Wisconsin Hosp/Clinics /ID# 207556

Madison, Wisconsin, United States

National Cancer Center Hospital East /ID# 230943

Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center /ID# 229737

Matsuyama, Ehime, Japan

Hokkaido Cancer Center /ID# 229101

Sapporo, Hokkaido, Japan

Shizuoka Cancer Center /ID# 230911

Sunto-gun, Shizuoka, Japan

Wakayama Medical University Hospital /ID# 229111

Wakayama, Wakayama, Japan

National Cancer Center /ID# 240169

Goyang, Gyeonggido, South Korea

Seoul National University Bundang Hospital /ID# 234274

Seongnam, Gyeonggido, South Korea

Yonsei University Health System Severance Hospital /ID# 239515

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 234272

Seoul, , South Korea

Asan Medical Center /ID# 234273

Seoul, , South Korea

National Cheng Kung University Hospital /ID# 234267

Tainan City, , Taiwan

Countries

United States; Japan; South Korea; Taiwan

References

Wiedemeyer WR, Gavrilyuk J, Schammel A, Zhao X, Sarvaiya H, Pysz M, Gu C, You M, Isse K, Sullivan T, French D, Lee C, Dang AT, Zhang Z, Aujay M, Bankovich AJ, Vitorino P. ABBV-011, A Novel, Calicheamicin-Based Antibody-Drug Conjugate, Targets SEZ6 to Eradicate Small Cell Lung Cancer Tumors. Mol Cancer Ther. 2022 Jun 1;21(6):986-998. doi: 10.1158/1535-7163.MCT-21-0851.

Reference Type: DERIVED

PMID: 35642431 (View on PubMed)

Other Identifiers

M17-327

Identifier Type: -

Identifier Source: org_study_id