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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Dose Expansion: Objective Response Rate (ORR) — 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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 — 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.
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 — 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.
Trial sites (26)
Facility
City
Region
Status
Highlands Oncology Group, PA /ID# 218863
Springdale
Arkansas
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa
California
Yale University School of Medicine /ID# 210678
New Haven
Connecticut
Moffitt Cancer Center /ID# 215037
Tampa
Florida
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
Fort Wayne
Indiana
Washington University-School of Medicine /ID# 221399
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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