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A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893955
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 + ABBV-368 with and without ABBV-181 in participants with selected solid tumors. This study consists of 2 main parts, dose-escalation and dose-expansion phases.

The trial will begin with dose escalation in Arm A (ABBV-927 + ABBV-368) which determines the recommended Phase 2 dose (RP2D)/maximum-tolerated dose (MTD) of ABBV-927 when administered with ABBV-368. Once the RP2D/MTD is defined in Arm A, enrollment will begin in the following arms: Arm 1 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm 2 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm B (ABBV-927 + ABBV-368 + ABBV-181) dose escalation. Once the RP2D/MTD is defined in Arm B, enrollment will begin in the following arms: Arm 3 (ABBV-927 + ABBV-368); Arm 4 (ABBV-927 + ABBV-368 + ABBV-181); Arm 5 (docetaxel).


Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Tumors Triple-Negative Breast Cancer (TNBC) Non-small-cell-lung-cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) Metastatic Solid Tumors Drug: ABBV-927 Drug: ABBV-368 Drug: ABBV-181 Drug: Docetaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : May 11, 2023
Estimated Study Completion Date : November 26, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
Subjects with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion
Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Subjects with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels, ABBV-368, and ABBV-181.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion

Drug: ABBV-181
intravenous infusion
Experimental: Dose Expansion Arm 1: ABBV-927 + ABBV-368 TNBC
Subjects with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 by IV infusion at the RP2D established for Arm A plus ABBV-368.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion
Experimental: Dose Expansion Arm 2: ABBV-927 + ABBV-368 HNSCC
Subjects with Head and Neck Squamous Cell Cancer (HNSCC) will receive ABBV-927 by IV at the RP2D established for Arm A plus ABBV-368.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion
Experimental: Dose Expansion Arm 3: ABBV-927 + ABBV-368 NSCLC
Subjects with NSCLC will receive ABBV-927 by IV at the RP2D established for Arm B plus ABBV-368.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion
Experimental: Dose Expansion Arm 4: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Subjects with NSCLC will receive ABBV-927 by IV at the RP2D established for Arm B plus ABBV-368 plus ABBV-181.
 Drug: ABBV-927
intravenous infusion

Drug: ABBV-368
intravenous infusion

Drug: ABBV-181
intravenous infusion
Experimental: Dose Expansion Arm 5: Docetaxel NSCLC
Subjects with NSCLC will receive 75 mg/m^2 by IV.
 Drug: Docetaxel
intravenous infusion
Other Names:
  • Taxotere
  • Docefrez


Outcome Measures
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Primary Outcome Measures :
  1. Dose Expansion: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years following the first dose of study drug ]
    ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  2. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 [ Time Frame: Up to approximately 6 months ]
    The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.

  3. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 [ Time Frame: Up to approximately 6 months ]
    The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.


Secondary Outcome Measures :
  1. Dose-Expansion Phase: Progression-free Survival (PFS) [ Time Frame: Up to approximately 2 years since the first dose of study drug ]
    PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.

  2. Dose-Expansion Phase: Duration of Response (DOR) [ Time Frame: Up to approximately 2 years since the first dose of study drug ]
    DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.

  3. Maximum Serum Concentration (Cmax) [ Time Frame: Up to approximately 12 weeks after participant's initial dose of study drug ]
    Maximum Serum Concentration (Cmax)

  4. Time to Maximum Observed Serum Concentration (Tmax) [ Time Frame: Up to approximately 12 weeks after participant's initial dose of study drug ]
    Time to Maximum Observed Serum Concentration (Tmax)

  5. Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ) [ Time Frame: Up to approximately 12 weeks after participant's initial dose of study drug ]
    Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).

  6. Terminal Phase Elimination Half-life (t1/2) [ Time Frame: Up to approximately 4 weeks after participant's initial dose of study drug ]
    Terminal Phase Elimination Half-life (t1/2)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Dose-Escalation:

  • Arm A: Participants with an advanced solid tumor who have progressed on standard therapies known to provide clinical benefit and/or subjects who have refused or are intolerant of such therapy.
  • Arm B (non-small-cell-lung-cancer [NSCLC]): Participants with histologically or cytologically confirmed NSCLC who previously progressed during or after an anti-programmed cell death (PD)-1 or PD ligand 1 (PD-L1) therapy and a platinum-based regimen in the recurrent or metastatic setting.

Dose-Expansion:

  • Arm 1 (triple-negative breast cancer [TNBC]): Participants with confirmed breast adenocarcinoma that is estrogen receptor/progesterone receptor/human epidermal growth factor receptor (HER)2-negative who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting and who are treatment-naïve to immunotherapy.
  • Arm 2 (head and neck squamous cell carcinoma [HNSCC]): Participants with histologically or cytologically confirmed HNSCC who previously progressed during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting.
  • Arms 3, 4, and 5 (NSCLC): Participants with histologically or cytologically confirmed NSCLC who previously progressed either during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting.

Exclusion Criteria:

  • Has history of inflammatory bowel disease or pneumonitis.
  • Has uncontrolled metastases to the central nervous system.
  • Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable.
  • Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed.

  • Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the course of their therapy:

    1. any immune-mediated toxicity of Grade 3 or worse severity
    2. treatment of the toxicity with systemic corticosteroids
    3. any hypersensitivity to the PD-1 or PD-L1-targeting agent
    4. any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent
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): NCT03893955


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Alabama
University of Alabama at Birmingham - Main /ID# 210679 Not yet recruiting
Birmingham, Alabama, United States, 35233
United States, California
St Jude Hospital dba St Joseph /ID# 211130 Not yet recruiting
Santa Rosa, California, United States, 95403
United States, Connecticut
Yale University /ID# 210678 Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, North Carolina
Carolina BioOncology Institute /ID# 210664 Recruiting
Huntersville, North Carolina, United States, 28078
United States, Texas
Mary Crowley Cancer Research /ID# 210716 Not yet recruiting
Dallas, Texas, United States, 75230
Duplicate Next Oncology /ID# 210717 Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists /ID# 210671 Not yet recruiting
Fairfax, Virginia, United States, 22031
France
Gustave Roussy /ID# 213052 Not yet recruiting
Villejuif, Ile-de-France, France, 94805
Institut de Cancer de l'Ouest /ID# 212880 Not yet recruiting
Angers, France, 49055
Hopital Bichat-Claude Bernard /ID# 212869 Not yet recruiting
Paris, France, 75018
Israel
Sheba Medical Center /ID# 211699 Recruiting
Ramat Gan, Israel, 5262100
Spain
Hospital Vall d'Hebron /ID# 212804 Not yet recruiting
Barcelona, Spain, 8035
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806 Not yet recruiting
Madrid, Spain, 28040
Hosp Univ Madrid Sanchinarro /ID# 212805 Not yet recruiting
Madrid, Spain, 28050
Taiwan
National Cheng Kung University Hospital /ID# 210994 Not yet recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 210993 Not yet recruiting
Taipei City, Taipei, Taiwan, 100
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03893955    
Other Study ID Numbers: M19-037
2019-000478-45 ( EudraCT Number )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
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
Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC)
Non-small-cell-lung-cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC)
ABBV-927
 ABBV-368
ABBV-181
metastatic solid tumors
dose-escalation
recommended phase 2 dose
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action