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

NCT03893955 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: M19-0372019-000478-45
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 26

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (3)

• Dose Expansion: Objective Response Rate (ORR)

  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.

  Up to approximately 2 years following the first dose of study drug

• Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368

  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.

  Up to approximately 6 months

• Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181

  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.

  Up to approximately 6 months

Secondary Outcomes (6)

• Dose-Expansion Phase: Progression-free Survival (PFS)

  Up to approximately 2 years since the first dose of study drug

• Dose-Expansion Phase: Duration of Response (DOR)

  Up to approximately 2 years since the first dose of study drug

• Maximum Serum Concentration (Cmax)

  Up to approximately 12 weeks after participant's initial dose of study drug

• Time to Maximum Observed Serum Concentration (Tmax)

  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)

  Up to approximately 12 weeks after participant's initial dose of study drug

Study Arms (7)

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.

Drug: ABBV-927; Drug: ABBV-368

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.

Drug: ABBV-927; Drug: ABBV-368; Drug: 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.

Drug: ABBV-927; Drug: ABBV-368; Drug: 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.

Drug: ABBV-927; Drug: ABBV-181; Drug: 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.

Drug: ABBV-927; Drug: Carboplatin

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.

Drug: ABBV-927; Drug: ABBV-368; Drug: 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.

Drug: ABBV-927; Drug: ABBV-368; Drug: ABBV-181

Interventions

ABBV-927 DRUG

Intravenous (IV) Infusion

Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors; Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC; Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC; Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC; Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC; Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC; Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC

ABBV-368 DRUG

Intravenous (IV) Infusion

Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors; Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC; Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC; Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC; Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC

ABBV-181 DRUG

Intravenous (IV) Infusion

Also known as: Budigalimab

Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC; Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC; Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC

Carboplatin DRUG

Intravenous (IV) Infusion

Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC; Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC; Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC

Nab-paclitaxel DRUG

Intravenous (IV) Infusion

Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (26)

Highlands Oncology Group, PA /ID# 218863

Springdale, Arkansas, 72762, United States

Location

St Jude Hospital dba St Joseph /ID# 211130

Santa Rosa, California, 95403, United States

Location

Yale University School of Medicine /ID# 210678

New Haven, Connecticut, 06510, United States

Location

Moffitt Cancer Center /ID# 215037

Tampa, Florida, 33612-9416, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072

Fort Wayne, Indiana, 46804, United States

Location

Washington University-School of Medicine /ID# 221399

St Louis, Missouri, 63110, United States

Location

Duke Cancer Center /ID# 217641

Durham, North Carolina, 27710-3000, United States

Location

Carolina BioOncology Institute /ID# 210664

Huntersville, North Carolina, 28078, United States

Location

UPMC Hillman Cancer Ctr /ID# 222747

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 221400

Nashville, Tennessee, 37203-1632, United States

Location

Mary Crowley Cancer Research /ID# 210716

Dallas, Texas, 75230, United States

Location

NEXT Oncology /ID# 210717

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 210671

Fairfax, Virginia, 22031, United States

Location

Duplicate_Icon Cancer Centre /ID# 224084

South Brisbane, Queensland, 4101, Australia

Location

Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Institut Curie /ID# 223475

Paris, Paris, 75248, France

Location

Centre Leon Berard /ID# 217910

Lyon, Rhone, 69373, France

Location

Centre Jean Perrin /ID# 217911

Clermont-Ferrand, 63011, France

Location

AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869

Paris, 75018, France

Location

The Chaim Sheba Medical Center /ID# 211699

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Hospital Universitario Vall d'Hebron /ID# 212804

Barcelona, 08035, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 212806

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 212805

Madrid, 28050, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 221671

Málaga, 29010, Spain

Location

National Taiwan University Hospital /ID# 210993

Taipei City, Taipei, 100, Taiwan

Location

China Medical University Hospital /ID# 221090

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

budigalimab; Carboplatin; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 28, 2019
• Study Start: May 21, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); TW (2); IL (1); US (13); AU (1); FR (5)