Breast Cancer Clinical Trial

A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

Summary

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel.

In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b).

In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

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Full Description

The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.

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Eligibility Criteria

Inclusion Criteria:

Has a histologic or cytologic diagnosis of a malignant solid tumor.
Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung cancer (SCLC) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC or HR-positive/HER2-negative breast cancer.
Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Failure of at least 1 prior systemic chemotherapy including all available standard therapies for participants in the dose-escalation phase (Parts 1a and 1b).

All participants with breast cancer for subjects in the dose-expansion phase (Part 2b only) must have the following:

Locally advanced or metastatic HR-positive/HER2-negative breast cancer after failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.
HR-positivity and HER-2-negativity should be confirmed based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria.
All participants with non-small cell lung cancer (NSCLC) for participants in the dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line of therapy.
All participants with SCLC in the dose-expansion phase (Part 2a only) must have R/R SCLC from at least 1 line of therapy which includes a platinum-based therapy with or without an anti-PD-1/PD-L1 therapy.

All participants with either breast cancer or NSCLC must have the following if exposed to prior taxane-based therapy:

No history of taxane allergy (Part 1b and Part 2b only).
Disease that has relapsed or progressed at least 2 months after most recent exposure to any taxane-based therapy.
Available tumor tissue suitable for immunohistochemistry testing.
Adequate kidney, liver, and hematologic laboratory values as described in the protocol.

Exclusion Criteria:

Untreated brain or meningeal metastases (participants with a history of metastases may be eligible based on details described in the protocol).
Grade 2 or higher peripheral neuropathy (only applies to participants who would receive taxane therapy).
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
Known active infection of hepatitis B, hepatitis C, or human immunodeficiency virus with exceptions as described in the protocol.
Recent history (within 6 months) of congestive heart failure (defined in the protocol), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
Any history of hypersensitivity to any ingredients of ABBV-155 will be excluded. For combination therapy only (Parts 1b and 2b), no history of serious allergic reaction to any taxane or any ingredients used in taxane formulation (e.g., cremaphor).

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

176

Study ID:

NCT03595059

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 40 Locations for this study

See Locations Near You

University of Alabama at Birmingham - Main /ID# 214024
Birmingham Alabama, 35233, United States
Highlands Oncology Group, PA /ID# 201568
Springdale Arkansas, 72762, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105
Orange California, 92868, United States
Cedars-Sinai Medical Center-West Hollywood /ID# 204267
West Hollywood California, 90048, United States
Univ of Colorado Cancer Center /ID# 208365
Aurora Colorado, 80045, United States
Yale University, Yale Cancer Center /ID# 201542
New Haven Connecticut, 06510, United States
AdventHealth Cancer Institute - Orlando /ID# 227242
Orlando Florida, 32804, United States
Northwestern University Feinberg School of Medicine /ID# 201563
Chicago Illinois, 60611, United States
Johns Hopkins Bayview Med Cnt /ID# 215095
Baltimore Maryland, 21224, United States
Johns Hopkins University /ID# 201320
Baltimore Maryland, 21287, United States
Dana-Farber Cancer Institute /ID# 201564
Boston Massachusetts, 02215, United States
Henry Ford Hospital /ID# 226852
Detroit Michigan, 48202, United States
Northwell Health - Marcus Ave /ID# 204376
New Hyde Park New York, 11042, United States
Carolina BioOncology Institute /ID# 201577
Huntersville North Carolina, 28078, United States
Univ Hosp Cleveland /ID# 201567
Cleveland Ohio, 44106, United States
University of Oklahoma, Stephenson Cancer Center /ID# 206820
Oklahoma City Oklahoma, 73104, United States More Info
Site Coordinator
Contact
844-663-3742
Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256
Providence Rhode Island, 02903, United States
Vanderbilt Ingram Cancer Center /ID# 201575
Nashville Tennessee, 37232, United States
Mary Crowley Cancer Research /ID# 214168
Dallas Texas, 75230, United States More Info
Site Coordinator
Contact
844-663-3742
MD Anderson Cancer Center /ID# 201558
Houston Texas, 77030, United States
NEXT Oncology /ID# 204893
San Antonio Texas, 78229, United States
Peter MacCallum Cancer Center /ID# 241676
Melbourne New South Wales, 3000, Australia
Cross Cancer Institute /ID# 213838
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre /ID# 204539
Toronto Ontario, M5G 2, Canada
The Chaim Sheba Medical Center /ID# 230812
Ramat Gan Tel-Aviv, 52656, Israel
Rambam Health Care Campus /ID# 230813
Haifa , 31096, Israel
National Cancer Center Hospital East /ID# 215130
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital /ID# 215003
Chuo-ku Tokyo, 104-0, Japan
National Cancer Center /ID# 241095
Goyang Gyeonggido, 10408, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 240648
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Antoni van Leeuwenhoek /ID# 222260
Amsterdam Noord-Holland, 1066 , Netherlands
Erasmus Medisch Centrum /ID# 222341
Rotterdam Zuid-Holland, 3015 , Netherlands
Maastricht Universitair Medisch Centrum /ID# 225220
Maastricht , 6229 , Netherlands
Universitair Medisch Centrum Utrecht /ID# 222357
Utrecht , 3584 , Netherlands
Pan American Center for Oncology Trials, LLC /ID# 232128
Rio Piedras , 00935, Puerto Rico More Info
Site Coordinator
Contact
844-663-3742
Hospital Universitario Fundacion Jimenez Diaz /ID# 239997
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 239999
Madrid , 28041, Spain
China Medical University Hospital /ID# 214062
Taichung City , 40447, Taiwan
National Cheng Kung University Hospital /ID# 206304
Tainan , 704, Taiwan
National Taiwan University Hospital /ID# 205673
Taipei City , 100, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

176

Study ID:

NCT03595059

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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