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

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

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.


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

Keywords: 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