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

NCT03639194 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: M17-327
• Study Type: interventional
• Target: 132
• Locations: 4 countries
• Sites: 32

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

Keywords

Cancer; Small Cell Lung Cancer; Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011

  The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 will be determined during the Part A dose escalation cohort.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab

  The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in combination with budigalimab will be determined during the Part C dose escalation cohort.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Number of Participants With Dose Limiting Toxicities (DLTs)

  DLTs are adverse events as described in the protocol.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Mean Change from Baseline in Vital Signs

  Mean change from Baseline in vital signs like blood pressure will be assessed.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Incidence of Laboratory Abnormaities

  Number of participants with lab abnormalities will be assessed.

  Up to approximately 5 years after the first participant receives first dose of study drug

• Mean Change from Baseline in Electrocardiogram (ECG) Parameters

  Mean change from Baseline in ECG parameters like QTc interval will be assessed.

  Up to approximately 5 years after the first participant receives first dose of study drug

Secondary Outcomes (16)

• Maximum Serum Concentration (Cmax) of ABBV-011

  Up to approximately 5 years after the first participant receives first dose of study drug

• Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011

  Up to approximately 5 years after the first participant receives first dose of study drug

• Area Under the Serum Concentration-Time Curve within a Dosing Interval (AUC0-t) of ABBV-011

  Up to approximately 5 years after the first participant receives first dose of study drug

• Time to Maximum Serum Concentration (Tmax) of ABBV-011

  Up to approximately 5 years after the first participant receives first dose of study drug

• Observed Serum Concentration at Trough (Ctrough) of ABBV-011

  Up to approximately 5 years after the first participant receives first dose of study drug

Study Arms (4)

Part A: ABBV-011 Dose Escalation

EXPERIMENTAL

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.

Drug: ABBV-011

Part B: ABBV-011 Dose Expansion

EXPERIMENTAL

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

Drug: ABBV-011

Part C: ABBV-011 + Budigalimab Escalation and Expansion

EXPERIMENTAL

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.

Drug: ABBV-011; Drug: Budigalimab

Part D: ABBV-011 Dose Evaluation for Japan

EXPERIMENTAL

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

Drug: ABBV-011

Interventions

ABBV-011 DRUG

Intravenous

Also known as: SC-011

Part A: ABBV-011 Dose Escalation; Part B: ABBV-011 Dose Expansion; Part C: ABBV-011 + Budigalimab Escalation and Expansion; Part D: ABBV-011 Dose Evaluation for Japan

Budigalimab DRUG

Intravenous

Also known as: ABBV-181

Part C: ABBV-011 + Budigalimab Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (32)

University of Alabama at Birmingham - Main /ID# 207295

Birmingham, Alabama, 35233, United States

Location

Highlands Oncology Group, PA /ID# 207176

Springdale, Arkansas, 72762, United States

Location

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

Sacramento, California, 95817, United States

Location

Yale School of Medicine /ID# 207559

New Haven, Connecticut, 06519, United States

Location

University of Iowa Hospitals and Clinics /ID# 207560

Iowa City, Iowa, 52242, United States

Location

University of Kentucky Chandler Medical Center /ID# 208217

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital /ID# 207549

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute /ID# 213032

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center /ID# 207177

Ann Arbor, Michigan, 48109-5000, United States

Location

Henry Ford Hospital /ID# 233539

Detroit, Michigan, 48202, United States

Location

Washington University-School of Medicine /ID# 207168

St Louis, Missouri, 63110, United States

Location

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

New York, New York, 10065-6007, United States

Location

Duke Cancer Center /ID# 207547

Durham, North Carolina, 27710, United States

Location

UH Cleveland Medical Center /ID# 207561

Cleveland, Ohio, 44106, United States

Location

The Ohio State University /ID# 207552

Columbus, Ohio, 43210, United States

Location

Tennessee Oncology, PLLC /ID# 207175

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Ingram Cancer Center /ID# 207551

Nashville, Tennessee, 37232-0021, United States

Location

NEXT Oncology /ID# 207167

San Antonio, Texas, 78229, United States

Location

University of Utah /ID# 207553

Salt Lake City, Utah, 84112-5500, United States

Location

University of Washington /ID# 207557

Seattle, Washington, 98109, United States

Location

Univ of Wisconsin Hosp/Clinics /ID# 207556

Madison, Wisconsin, 53792-0001, United States

Location

National Cancer Center Hospital East /ID# 230943

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center /ID# 229737

Matsuyama, Ehime, 791-0280, Japan

Location

Hokkaido Cancer Center /ID# 229101

Sapporo, Hokkaido, 003-0804, Japan

Location

Shizuoka Cancer Center /ID# 230911

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Wakayama Medical University Hospital /ID# 229111

Wakayama, Wakayama, 641-8510, Japan

Location

National Cancer Center /ID# 240169

Goyang, Gyeonggido, 10408, South Korea

Location

Seoul National University Bundang Hospital /ID# 234274

Seongnam, Gyeonggido, 13620, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 239515

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul National University Hospital /ID# 234272

Seoul, 03080, South Korea

Location

Asan Medical Center /ID# 234273

Seoul, 05505, South Korea

Location

National Cheng Kung University Hospital /ID# 234267

Tainan, 704, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35642431 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasms

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: October 24, 2018
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5); KR (5); US (21); TW (1)