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
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ClinicalTrials.gov Identifier: NCT03893955 |
Recruitment Status :
Recruiting
First Posted : March 28, 2019
Last Update Posted : January 23, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cancer Advanced Solid Tumors Triple-Negative Breast Cancer (TNBC) Non-small-cell-lung-cancer (NSCLC) Metastatic Solid Tumors | Drug: ABBV-927 Drug: ABBV-368 Drug: ABBV-181 Drug: Carboplatin Drug: Nab-paclitaxel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 21, 2019 |
Estimated Primary Completion Date : | November 12, 2023 |
Estimated Study Completion Date : | November 12, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
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.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-368 Intravenous (IV) Infusion |
Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
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.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-368 Intravenous (IV) Infusion Drug: ABBV-181 Intravenous (IV) Infusion
Other Name: Budigalimab |
Experimental: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC
Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-368 Intravenous (IV) Infusion Drug: Carboplatin Intravenous (IV) Infusion |
Experimental: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-181 Intravenous (IV) Infusion
Other Name: Budigalimab Drug: Carboplatin Intravenous (IV) Infusion |
Experimental: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: Carboplatin Intravenous (IV) Infusion |
Experimental: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-368 Intravenous (IV) Infusion Drug: Nab-paclitaxel Intravenous (IV) Infusion |
Experimental: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
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Drug: ABBV-927
Intravenous (IV) Infusion Drug: ABBV-368 Intravenous (IV) Infusion Drug: ABBV-181 Intravenous (IV) Infusion
Other Name: Budigalimab |
- Dose Expansion: Objective Response Rate (ORR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Dose-Expansion Phase: Progression-free Survival (PFS) [ Time Frame: 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.
- Dose-Expansion Phase: Duration of Response (DOR) [ Time Frame: 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) [ Time Frame: Up to approximately 12 weeks after participant's initial dose of study drug ]Maximum Serum Concentration (Cmax)
- Time to Maximum Observed Serum Concentration (Tmax) [ Time Frame: Up to approximately 12 weeks after participant's initial dose of study drug ]Time to Maximum Observed Serum Concentration (Tmax)
- 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 ]Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).
- Terminal Phase Elimination Half-life (t1/2) [ Time Frame: Up to approximately 4 weeks after participant's initial dose of study drug ]Terminal Phase Elimination Half-life (t1/2)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893955
Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |

Study Director: | ABBVIE INC. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03893955 |
Other Study ID Numbers: |
M19-037 2019-000478-45 ( EudraCT Number ) |
First Posted: | March 28, 2019 Key Record Dates |
Last Update Posted: | January 23, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
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 |
Neoplasms Carcinoma, Non-Small-Cell Lung Triple Negative Breast Neoplasms Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |