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

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors; Cancer; Triple-Negative Breast Cancer (TNBC); Non-small-cell-lung-cancer (NSCLC); Metastatic Solid Tumors
• Interventions: Drug: ABBV-927; Drug: ABBV-368; Drug: Carboplatin; Drug: ABBV-181; Drug: Nab-paclitaxel

• Registration Number: NCT03893955
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Study Start: 2019-05-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC	ABBV-368	Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC	ABBV-927	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 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC	ABBV-927	Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors	ABBV-368	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	ABBV-368	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	ABBV-927	Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC	ABBV-927	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC	Nab-paclitaxel	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC	ABBV-368	Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC	ABBV-927	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC	ABBV-927	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	ABBV-368	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC	Carboplatin	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors	ABBV-927	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 Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC	ABBV-181	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC	ABBV-181	Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC	ABBV-181	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	Carboplatin	Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC	Carboplatin	Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Maximum Serum Concentration (Cmax)	Up to approximately 12 weeks after participant's initial dose of study drug	Maximum Serum Concentration (Cmax)
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.
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)
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.

Trial Locations

Locations (26)

Highlands Oncology Group, PA /ID# 218863; 🇺🇸 Springdale, Arkansas, United States

St Jude Hospital dba St Joseph /ID# 211130; 🇺🇸 Santa Rosa, California, United States

Yale University School of Medicine /ID# 210678; 🇺🇸 New Haven, Connecticut, United States

Moffitt Cancer Center /ID# 215037; 🇺🇸 Tampa, Florida, United States

Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072; 🇺🇸 Fort Wayne, Indiana, United States

Washington University-School of Medicine /ID# 221399; 🇺🇸 Saint Louis, Missouri, United States

Duke Cancer Center /ID# 217641; 🇺🇸 Durham, North Carolina, United States

Carolina BioOncology Institute /ID# 210664; 🇺🇸 Huntersville, North Carolina, United States

UPMC Hillman Cancer Ctr /ID# 222747; 🇺🇸 Pittsburgh, Pennsylvania, United States

Tennessee Oncology-Nashville Centennial /ID# 221400; 🇺🇸 Nashville, Tennessee, United States

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