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

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ClinicalTrials.gov Identifier: NCT03639194
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: ABBV-011 Drug: Budigalimab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : January 25, 2024
Actual Study Completion Date : January 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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
Other Name: SC-011
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.
 Drug: ABBV-011
Intravenous
Other Name: SC-011
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: ABBV-011
Intravenous
Other Name: SC-011

Drug: Budigalimab
Intravenous
Other Name: ABBV-181
Experimental: 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.
 Drug: ABBV-011
Intravenous
Other Name: SC-011


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    DLTs are adverse events as described in the protocol.

  5. Mean Change from Baseline in Vital Signs [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    Mean change from Baseline in vital signs like blood pressure will be assessed.

  6. Incidence of Laboratory Abnormaities [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    Number of participants with lab abnormalities will be assessed.

  7. 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 ]
    Mean change from Baseline in ECG parameters like QTc interval will be assessed.


Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of ABBV-011 [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    Maximum Serum Concentration (Cmax) of ABBV-011.

  2. 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 ]
    Area under the serum concentration-time curve within a dosing interval of ABBV-011.

  3. Area Under the Serum Concentration-Time Curve within a Dosing Interval (AUC0-t) of ABBV-011 [ Time Frame: 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.

  4. 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 ]
    Time to maximum serum concentration (Tmax) of ABBV-011.

  5. 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 ]
    Observed serum concentration at trough (Ctrough) of ABBV-011.

  6. 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 ]
    Apparent terminal half-life (T1/2) of ABBV-011.

  7. Accumulation Ratio of ABBV-011 [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    Accumulation ratio of ABBV-011.

  8. Serum Clearance (CL) of ABBV-011 [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    Serum clearance of ABBV011.

  9. 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 ]
    Steady state volume of distribution (Vss) of ABBV-011.

  10. 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 ]
    Number of participants with incidence of ADAs against ABBV-011 or budigalimab will be assessed.

  11. 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 ]
    ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR).

  12. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD).

  13. Duration of Response (DOR) [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    DOR is defined as the time from the participant's initial objective response (CR or PR) to Progressive Disease (PD) or death due to any cause, whichever occurs first.

  14. Duration of Clinical Benefit (DOCB) [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    (DOCB) is defined as the time from the participant's initial observation of clinical benefit (CR or PR or SD) to PD or death due to any cause, whichever occurs first.

  15. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression (PD) or death due to any cause, whichever occurs first.

  16. Overall Survival (OS) [ Time Frame: Up to approximately 5 years after the first participant receives first dose of study drug ]
    OS is defined as the time from the subject's first dose date to death due to any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

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.

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.
  • 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).

Additional exclusion criteria for Japanese and Korean participants:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639194


Locations
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Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: ABBVIE INC. AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03639194    
Other Study ID Numbers: M17-327
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Cancer
Small Cell Lung Cancer
Small Cell Lung Carcinoma
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms