Description:
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.
Title
- Brief Title: 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
- Official Title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
M19-037
- SECONDARY ID:
2019-000478-45
- NCT ID:
NCT03893955
Conditions
- Cancer
- Advanced Solid Tumors
- Triple-Negative Breast Cancer (TNBC)
- Non-small-cell-lung-cancer (NSCLC)
- Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
ABBV-927 | | Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors |
ABBV-368 | | Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors |
ABBV-181 | Budigalimab | Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC |
Carboplatin | | Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC |
Nab-paclitaxel | | Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors | Experimental | 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. | |
Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | Experimental | 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. | |
Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC | Experimental | 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
- ABBV-368
- Carboplatin
|
Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC | Experimental | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV. | - ABBV-927
- ABBV-181
- Carboplatin
|
Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC | Experimental | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV. | |
Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC | Experimental | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV. | - ABBV-927
- ABBV-368
- Nab-paclitaxel
|
Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | Experimental | Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Expansion: Objective Response Rate (ORR) |
Time Frame: | Up to approximately 2 years following the first dose of study drug |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Dose-Expansion Phase: Progression-free Survival (PFS) |
Time Frame: | Up to approximately 2 years since the first dose of study drug |
Safety Issue: | |
Description: | PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first. |
Measure: | Dose-Expansion Phase: Duration of Response (DOR) |
Time Frame: | Up to approximately 2 years since the first dose of study drug |
Safety Issue: | |
Description: | DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first. |
Measure: | Maximum Serum Concentration (Cmax) |
Time Frame: | Up to approximately 12 weeks after participant's initial dose of study drug |
Safety Issue: | |
Description: | Maximum Serum Concentration (Cmax) |
Measure: | Time to Maximum Observed Serum Concentration (Tmax) |
Time Frame: | Up to approximately 12 weeks after participant's initial dose of study drug |
Safety Issue: | |
Description: | Time to Maximum Observed Serum Concentration (Tmax) |
Measure: | Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ) |
Time Frame: | Up to approximately 12 weeks after participant's initial dose of study drug |
Safety Issue: | |
Description: | Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ). |
Measure: | Terminal Phase Elimination Half-life (t1/2) |
Time Frame: | Up to approximately 4 weeks after participant's initial dose of study drug |
Safety Issue: | |
Description: | Terminal Phase Elimination Half-life (t1/2) |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AbbVie |
Trial 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
Last Updated
July 26, 2021