Cancer, Advanced Solid Tumors, Triple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), Metastatic Solid Tumors
Conditions
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
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.
Interventions
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Observed Serum Concentration (Tmax) | Up to approximately 12 weeks after participant's initial dose of study drug | Time to Maximum Observed Serum Concentration (Tmax) |
| Dose-Expansion Phase: Progression-free Survival (PFS) | 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. |
| Terminal Phase Elimination Half-life (t1/2) | Up to approximately 4 weeks after participant's initial dose of study drug | Terminal Phase Elimination Half-life (t1/2) |
| Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ) | 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). |
| Dose-Expansion Phase: Duration of Response (DOR) | 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. |
| Maximum Serum Concentration (Cmax) | Up to approximately 12 weeks after participant's initial dose of study drug | Maximum Serum Concentration (Cmax) |
Countries
Australia, France, Israel, Spain, Taiwan, United States
Outcome results
None listed