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A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

NCT03595059

Description:

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), subjects will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), subjects will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll subjects with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll subjects with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
  • Official Title: A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: M16-573
  • NCT ID: NCT03595059

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
ABBV-155Escalation 1a: ABBV-155
PaclitaxelEscalation 1b: ABBV-155 + paclitaxel or docetaxel
DocetaxelExpansion 2b: ABBV-155 + docetaxel in NSCLC

Purpose

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), subjects will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), subjects will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll subjects with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll subjects with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

Trial Arms

NameTypeDescriptionInterventions
Escalation 1a: ABBV-155ExperimentalSubjects will be administered ABBV-155 (various doses).
  • ABBV-155
Escalation 1b: ABBV-155 + paclitaxel or docetaxelExperimentalSubjects will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
  • ABBV-155
  • Paclitaxel
  • Docetaxel
Expansion 2a: ABBV-155 in SCLCExperimentalDescription: Subjects with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
  • ABBV-155
Expansion 2b: ABBV-155 + paclitaxel in Breast CancerExperimentalSubjects with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.
  • ABBV-155
  • Paclitaxel
Expansion 2b: ABBV-155 + docetaxel in NSCLCExperimentalSubjects with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.
  • ABBV-155
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Has a histologic or cytologic diagnosis of a malignant solid tumor.

          -  Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST)
             criteria.

          -  An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             2.

          -  Failure of at least 1 prior systemic chemotherapy including all available standard
             therapies.

          -  All subjects with either breast cancer or non-small cell lung cancer (NSCLC) must have
             the following: exposure to prior taxane-based therapy; no history of taxane allergy
             (Part 1b and Part 2b only); and disease that has relapsed or progressed at least 2
             months after most recent exposure to any taxane-based therapy.

          -  Available tumor tissue suitable for immunohistochemistry testing.

          -  Adequate kidney, liver, and hematologic laboratory values as described in the
             protocol.

          -  Subjects enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung
             cancer (SCLC) with tumors that express B7H3 above a given threshold per central
             laboratory testing; subjects enrolled to Part 2b (combination therapy, dose expansion)
             must have either NSCLC or breast cancer with tumors that express B7H3 above a given
             threshold per central laboratory testing.

        Exclusion Criteria:

          -  History of severe osteoporosis with previous spontaneous fractures.

          -  Untreated brain or meningeal metastases (subjects with a history of metastases may be
             eligible based on details described in the protocol).

          -  Grade 2 or higher peripheral neuropathy (only applies to subjects who would receive
             taxane therapy).

          -  Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except
             alopecia.

          -  Known active infection of hepatitis B, hepatitis C, or human immunodeficiency virus
             with exceptions as described in the protocol.

          -  Recent history (within 6 months) of congestive heart failure (defined in the
             protocol), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological
             or surgical intervention, pericardial effusion, or pericarditis.

          -  For combination therapy only (Parts 1b and 2b), history of serious allergic reaction
             to any taxane or any ingredients used in taxane formulation.
      
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 ABBV-155
Time Frame:Up to approximately 21 days after initial dose of study drug
Safety Issue:
Description:The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Up to approximately 12 months
Safety Issue:
Description:DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first.
Measure:Rate of Complete Response (CR)
Time Frame:Up to approximately 2 to 6 months
Safety Issue:
Description:CR is defined as the percentage of subjects with documented best response CR according to RECIST version 1.1
Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 12 months
Safety Issue:
Description:PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first.
Measure:Overall Survival (OS)
Time Frame:Up to approximately 12 months after last dose of study drug
Safety Issue:
Description:OS is defined as the number of days from the date of first study drug to the date of death due to any cause.
Measure:Cmax
Time Frame:Up to approximately 48 days
Safety Issue:
Description:Maximum plasma concentration (Cmax).
Measure:Tmax of ABBV-155
Time Frame:Up to approximately 48 days
Safety Issue:
Description:Time to maximum plasma concentration (Tmax).
Measure:Terminal Phase Elimination Rate constant of ABBV-155
Time Frame:Up to approximately 48 days
Safety Issue:
Description:Terminal phase elimination rate constant of ABBV-155
Measure:AUCt
Time Frame:Up to approximately 48 days
Safety Issue:
Description:Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).
Measure:AUC∞
Time Frame:Up to approximately 48 days
Safety Issue:
Description:AUC from time 0 to infinite time (AUC∞).
Measure:QTcF Change from Baseline
Time Frame:Up to approximately 8 days
Safety Issue:
Description:QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.
Measure:t1/2
Time Frame:Up to approximately 48 days
Safety Issue:
Description:Terminal elimination half-life (t1/2).

Details

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

Trial Keywords

  • Cancer
  • Advanced Solid Tumors
  • Relapsed and/or Refractory Solid Tumors
  • ABBV-155
  • Taxane
  • Paclitaxel
  • Docetaxel
  • breast cancer
  • non-small cell lung cancer (NSCLC)
  • small cell lung cancer (SCLC)

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