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Active, not recruiting Phase 1

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 · tracked via the Priya Life Science Israel tracker
Sponsor
Phase
Phase 1
Started
2019-05-21
Last updated
2026-09-02

Condition(s) studied

CancerAdvanced Solid TumorsTriple-Negative Breast Cancer (TNBC)Non-small-cell-lung-cancer (NSCLC)Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ABBV-927 →ABBV-368ABBV-181 →Carboplatin →Nab-paclitaxel →

ABBV-927: Intravenous (IV) Infusion

ABBV-368: Intravenous (IV) Infusion

ABBV-181: Intravenous (IV) Infusion

Carboplatin: Intravenous (IV) Infusion

Nab-paclitaxel: Intravenous (IV) Infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (26)

FacilityCityRegionStatus
Highlands Oncology Group, PA /ID# 218863 Springdale Arkansas
St Jude Hospital dba St Joseph /ID# 211130 Santa Rosa California
Yale University School of Medicine /ID# 210678 New Haven Connecticut
Moffitt Cancer Center /ID# 215037 Tampa Florida
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 Fort Wayne Indiana
Washington University-School of Medicine /ID# 221399 St Louis Missouri
Duplicate_Duke Cancer Center /ID# 217641 Durham North Carolina
Carolina BioOncology Institute /ID# 210664 Huntersville North Carolina
UPMC Hillman Cancer Ctr /ID# 222747 Pittsburgh Pennsylvania
Tennessee Oncology-Nashville Centennial /ID# 221400 Nashville Tennessee
Mary Crowley Cancer Research /ID# 210716 Dallas Texas
NEXT Oncology /ID# 210717 San Antonio Texas
Virginia Cancer Specialists - Fairfax /ID# 210671 Fairfax Virginia
Duplicate_Icon Cancer Centre /ID# 224084 South Brisbane Queensland
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880 Saint-Herblain Loire-Atlantique
Institut Curie /ID# 223475 Paris Paris
Centre Leon Berard /ID# 217910 Lyon Rhone
Centre Jean Perrin /ID# 217911 Clermont-Ferrand France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869 Paris France
The Chaim Sheba Medical Center /ID# 211699 Ramat Gan Tel Aviv
Hospital Universitario Vall de Hebron /ID# 212804 Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806 Madrid Spain
Hospital Universitario HM Sanchinarro /ID# 212805 Madrid Spain
Hospital Universitario Virgen de la Victoria /ID# 221671 Málaga Spain
China Medical University Hospital /ID# 221090 Taichung Taiwan
National Taiwan University Hospital /ID# 210993 Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03893955 on ClinicalTrials.gov ↗ ← All trials in Israel