Clinical Trial - NCT03639194

       

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

Recruiting

Sponsor: AbbVie

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03639194

Protocol Info

Short Description: Phase 1 SC-011 + ABBV-181 in Small Cell Lung Cancer
Long Description: A Phase 1 Study of SC-011 as a Single-Agent and in Combination with ABBV-181 in Subjects with Relapsed or Refractory Small Cell Lung Cancer
MGH Status: Open
Sponsor: AbbVie
Disease Program: Thoracic

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Small Cell Lung Cancer ABBV-011 Budigalimab Phase 1
Study Type Interventional
Official Title A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Primary Outcome Measures

Number of Participants With Adverse Events [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Number of Participants With Dose Limiting Toxicities (DLTs) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Mean Change from Baseline in Vital Signs [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Incidence of Laboratory Abnormaities [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Mean Change from Baseline in Electrocardiogram (ECG) Parameters [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]


Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Area Under the Serum Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-t) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Time to Maximum Serum Concentration (Tmax) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Observed Serum Concentration at Trough (Ctrough) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Apparent Terminal Half-Life (T1/2) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Accumulation Ratio of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Serum Clearance (CL) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Steady State Volume of Distribution (Vss) of ABBV-011 [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Incidence of Antidrug Antibodies (ADA) Against ABBV-011 or Budigalimab (ABBV-181) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Clinical Benefit Rate (CBR) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Duration of Response (DOR) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Duration of Clinical Benefit (DOCB) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Progression-Free Survival (PFS) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug] [Designated as safety issue: ]

Estimated Enrollment: 188
Study Start Date: October 2018
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2023
Arms Assigned Interventions

Experimental: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.
Drug:ABBV-011
Intravenous

Experimental: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.

Experimental: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.
Drug:Budigalimab
Intravenous

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.
  • • All participants in Part B and Part C will be required to have tumor tissue that tests positive for target expression.

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.
  • • 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03639194

Locations

  • United States, Alabama
    • University of Alabama at Birmingham - Main /ID# 207295 Birmingham, Alabama, United States, 35233
  • United States, Arkansas
    • Highlands Oncology Group /ID# 207176 Fayetteville, Arkansas, United States, 72703-4005
  • United States, California
    • UC Davis Comprehensive Cancer Center - Main /ID# 207548 Sacramento, California, United States, 95817
  • United States, Connecticut
    • Yale School of Medicine /ID# 207559 New Haven, Connecticut, United States, 06519
  • United States, Iowa
    • University of Iowa Hospitals and Clinics /ID# 207560 Iowa City, Iowa, United States, 52242
  • United States, Kentucky
    • University of Kentucky Chandler Medical Center /ID# 208217 Lexington, Kentucky, United States, 40536
  • United States, Massachusetts
    • Massachusetts General Hospital /ID# 207549 Boston, Massachusetts, United States, 02114
    • Duplicate_Dana Farber Cancer Inst., US /ID# 213032 Boston, Massachusetts, United States, 02115
    • Beth Israel Deaconess Medical Center /ID# 213031 Boston, Massachusetts, United States, 02215-5400
  • United States, Michigan
    • University of Michigan Hospitals /ID# 207177 Ann Arbor, Michigan, United States, 48109
  • United States, Minnesota
    • Mayo Clinic - /ID# 207555 Rochester, Minnesota, United States, 55905-0001
  • United States, Missouri
    • Washington University-School of Medicine /ID# 207168 Saint Louis, Missouri, United States, 63110
  • United States, New York
    • Memorial Sloan Kettering Cancer Center /ID# 208216 New York, New York, United States, 10065-6007
  • United States, North Carolina
    • Duke Cancer Center /ID# 207547 Durham, North Carolina, United States, 27710
  • United States, Ohio
    • University Hospitals Cleveland /ID# 207561 Cleveland, Ohio, United States, 44106
    • The Ohio State University Comp /ID# 207552 Columbus, Ohio, United States, 43210
  • United States, Tennessee
    • Tennessee Oncology-Nashville Centennial /ID# 207175 Nashville, Tennessee, United States, 37203-1632
    • Vanderbilt University Med Ctr /ID# 207551 Nashville, Tennessee, United States, 37232-6307
  • United States, Texas
    • NEXT Oncology /ID# 207167 San Antonio, Texas, United States, 78229
  • United States, Utah
    • University of Utah Huntsman /ID# 207553 Salt Lake City, Utah, United States, 84112
  • United States, Washington
    • University of Washington /ID# 207557 Seattle, Washington, United States, 98109-1024
  • United States, Wisconsin
    • Univ of Wisconsin Hosp/Clinics /ID# 207556 Madison, Wisconsin, United States, 53792-0001

Sponsors and Collaborators

AbbVie

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03639194
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by AbbVie:

Cancer

Small Cell Lung Cancer

Small Cell Lung Carcinoma

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on September 03, 2020