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A Study of ABBV-011 Alone and in Combination With ABBV-181 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

NCT03639194

Description:

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with ABBV-181 in subjects 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 ABBV-181 combination escalation and expansion cohort.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of SC-011 Alone and in Combination With ABBV-181 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
  • Official Title: A Phase I Study of SC-011 as a Single-Agent and in Combination With ABBV-181 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: M17-327
  • NCT ID: NCT03639194

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
SC-011Part A: SC-011 Dose Escalation
ABBV-181Part C: SC-011 + ABBV-181 Escalation and Expansion

Purpose

This is a multicenter, open-label, Phase 1 study of SC-011 given as a single agent and in combination with ABBV-181 in subjects with relapsed or refractory small cell lung cancer (SCLC). The study consists of 3 parts: Part A is a single-agent SC-011 dose-finding regimen cohort; followed by Part B, a single-agent SC-011 dose expansion cohort; and then Part C, an SC-011 and ABBV-181 combination escalation and expansion cohort.

Trial Arms

NameTypeDescriptionInterventions
Part A: SC-011 Dose EscalationExperimentalSC-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.
  • SC-011
Part B: SC-011 Dose ExpansionExperimentalSC-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.
  • SC-011
Part C: SC-011 + ABBV-181 Escalation and ExpansionExperimentalSC-011 via intravenous administration at various doses and dosing regimens starting at least 1 dose level below the recommended single-agent dose of SC-011 for Part B plus ABBV-181 via intravenous administration at fixed doses and various dosing regimens.
  • SC-011
  • ABBV-181

Eligibility Criteria

        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 subjects 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.

          -  Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD
             requiring treatment with steroids.

          -  Creatinine clearance < 50 mL/minute.

          -  Subjects previously treated with an anti PD-1/PD-L1 targeting agent must meet
             additional criteria described in the protocol.

          -  Subject 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:MTD and/or RPTD of SC-011
Time Frame:Up to approximately 24 months
Safety Issue:
Description:The Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of SC-011 will be determined during the Part A dose escalation cohort.

Secondary Outcome Measures

Measure:Maximum Serum Concentration (Cmax) of SC-011
Time Frame:Up to approximately 15 weeks after first dose of study drug
Safety Issue:
Description:Maximum Serum Concentration (Cmax) of SC-011
Measure:AUCinf of SC-011
Time Frame:Up to approximately 15 weeks after first dose of study drug
Safety Issue:
Description:Area under the serum concentration-time curve within a dosing interval of SC-011
Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 15 weeks after first dose of study drug
Safety Issue:
Description:ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) (CR+PR).
Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:Clinical benefit rate (CBR) is defined as the proportion of subjects with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD).
Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description: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.
Measure:Duration of Objective Response (DOR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:DOR is defined as the time from the subject's initial objective response (CR or PR) to PD or death due to any cause, whichever occurs first.
Measure:Duration of Clinical Benefit (DOCB)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:DOCB is defined as the time from the subject's initial observation of clinical benefit (CR or PR or SD) to PD or death due to any cause, whichever occurs first.
Measure:Overall Survival (OS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:OS is defined as the time from the subject's first dose date to death due to any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma

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