Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT03893955

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 26 Locations for this study

See Locations Near You

Highlands Oncology Group, PA /ID# 218863
Springdale Arkansas, 72762, United States
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa California, 95403, United States
Yale University /ID# 210678
New Haven Connecticut, 06510, United States
Moffitt Cancer Center /ID# 215037
Tampa Florida, 33612, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
Fort Wayne Indiana, 46804, United States
Washington University-School of Medicine /ID# 221399
Saint Louis Missouri, 63110, United States
Duke Cancer Center /ID# 217641
Durham North Carolina, 27710, United States
Carolina BioOncology Institute /ID# 210664
Huntersville North Carolina, 28078, United States
UPMC Hillman Cancer Ctr /ID# 222747
Pittsburgh Pennsylvania, 15232, United States
Tennessee Oncology-Nashville Centennial /ID# 221400
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research /ID# 210716
Dallas Texas, 75230, United States
NEXT Oncology /ID# 210717
San Antonio Texas, 78229, United States
Virginia Cancer Specialists - Fairfax /ID# 210671
Fairfax Virginia, 22031, United States
Icon Cancer Centre /ID# 224084
South Brisbane Queensland, 4101, Australia
Institut Curie /ID# 223475
Paris CEDEX 05 Ile-de-France, 75248, France
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880
St Herblain CEDEX Loire-Atlantique, 44805, France
Centre Leon Berard /ID# 217910
Lyon CEDEX 08 Rhone, 69373, France
Centre Jean Perrin /ID# 217911
Clermont Ferrand , 63011, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869
Paris , 75018, France
The Chaim Sheba Medical Center /ID# 211699
Ramat Gan Tel-Aviv, 52656, Israel
Hospital Universitario Vall d'Hebron /ID# 212804
Barcelona , 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro /ID# 212805
Madrid , 28050, Spain
Hospital Universitario Virgen de la Victoria /ID# 221671
Malaga , 29010, Spain
China Medical University Hospital /ID# 221090
Taichung City , 40447, Taiwan
National Taiwan University Hospital /ID# 210993
Taipei City , 100, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT03893955

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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