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
NCT ID: NCT03893955
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2019-05-21
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
ABBV-181
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
Carboplatin
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
ABBV-181
Intravenous (IV) Infusion
Carboplatin
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
Carboplatin
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
Nab-paclitaxel
Intravenous (IV) Infusion
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.
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
ABBV-181
Intravenous (IV) Infusion
Interventions
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ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
ABBV-181
Intravenous (IV) Infusion
Carboplatin
Intravenous (IV) Infusion
Nab-paclitaxel
Intravenous (IV) Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Highlands Oncology Group, PA /ID# 218863
Springdale, Arkansas, United States
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa, California, United States
Yale University School of Medicine /ID# 210678
New Haven, Connecticut, United States
Moffitt Cancer Center /ID# 215037
Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
Fort Wayne, Indiana, United States
Washington University-School of Medicine /ID# 221399
St Louis, Missouri, United States
Duke Cancer Center /ID# 217641
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 210664
Huntersville, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 222747
Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville Centennial /ID# 221400
Nashville, Tennessee, United States
Mary Crowley Cancer Research /ID# 210716
Dallas, Texas, United States
NEXT Oncology /ID# 210717
San Antonio, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 210671
Fairfax, Virginia, United States
Duplicate_Icon Cancer Centre /ID# 224084
South Brisbane, Queensland, Australia
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880
Saint-Herblain, Loire-Atlantique, France
Institut Curie /ID# 223475
Paris, Paris, France
Centre Leon Berard /ID# 217910
Lyon, Rhone, France
Centre Jean Perrin /ID# 217911
Clermont-Ferrand, , France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869
Paris, , France
The Chaim Sheba Medical Center /ID# 211699
Ramat Gan, Tel Aviv, Israel
Hospital Universitario Vall d'Hebron /ID# 212804
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 212805
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 221671
Málaga, , Spain
National Taiwan University Hospital /ID# 210993
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 221090
Taichung, , Taiwan
Countries
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Other Identifiers
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2019-000478-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-037
Identifier Type: -
Identifier Source: org_study_id
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