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Trial record 1 of 1 for:    M19-037
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A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03893955
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Tumors Triple-Negative Breast Cancer (TNBC) Non-small-cell-lung-cancer (NSCLC) Metastatic Solid Tumors Drug: ABBV-927 Drug: ABBV-368 Drug: ABBV-181 Drug: Carboplatin Drug: Nab-paclitaxel Phase 1

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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 Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy 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


Arm Intervention/treatment
Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-368
Intravenous (IV) Infusion

Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-368
Intravenous (IV) Infusion

Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab

Experimental: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC
Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-368
Intravenous (IV) Infusion

Drug: Carboplatin
Intravenous (IV) Infusion

Experimental: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab

Drug: Carboplatin
Intravenous (IV) Infusion

Experimental: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: Carboplatin
Intravenous (IV) Infusion

Experimental: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-368
Intravenous (IV) Infusion

Drug: Nab-paclitaxel
Intravenous (IV) Infusion

Experimental: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Drug: ABBV-927
Intravenous (IV) Infusion

Drug: ABBV-368
Intravenous (IV) Infusion

Drug: ABBV-181
Intravenous (IV) Infusion
Other Name: Budigalimab




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)



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 participants 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, 2, and 3 (triple-negative breast cancer [TNBC]): Participants with histologically or cytologically 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 4 (TNBC): Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay.
  • Arm 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:
  • any immune-mediated toxicity of Grade 3 or worse severity
  • treatment of the toxicity with systemic corticosteroids
  • any hypersensitivity to the PD-1 or PD-L1-targeting agent
  • any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent

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, 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 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
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
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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: March 11, 2020
Last Verified: March 2020
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)
ABBV-927
ABBV-368
ABBV-181
metastatic solid tumors
dose-escalation
recommended phase 2 dose
budigalimab
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Neoplasms
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
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action