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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

NCT03893955

Active Not RecruitingPhase 1

Sponsor: AbbVie

Conditions: Cancer, Advanced Solid Tumors, Triple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), Metastatic Solid Tumors

Interventions: ABBV-927, ABBV-368, ABBV-181, Carboplatin, Nab-paclitaxel

Countries: United States, Australia, France, Israel, Spain, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (26)

Springdale, Arkansas, United States
Santa Rosa, California, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
Fort Wayne, Indiana, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
South Brisbane, Queensland, Australia
Saint-Herblain, Loire-Atlantique, France
Paris, Paris, France
Lyon, Rhone, France
Clermont-Ferrand, France
Paris, France
Ramat Gan, Tel Aviv, Israel
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Málaga, Spain
Taichung, Taiwan
Taipei, Taiwan