🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT03893955
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 China tracker
Sponsor
AbbVie
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)

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

More AbbVie trials in China

Other trials for the same condition

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 China