A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
NCT ID: NCT03595059
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
168 participants
INTERVENTIONAL
2018-07-13
2025-09-12
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Escalation 1a: ABBV-155
Participants will be administered ABBV-155 (various doses).
ABBV-155
Intravenous (IV) Infusion
Escalation 1b: ABBV-155 + paclitaxel or docetaxel
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
ABBV-155
Intravenous (IV) Infusion
Paclitaxel
Intravenous (IV) Infusion
Docetaxel
Intravenous (IV) Infusion
Expansion 2a: ABBV-155 in SCLC
Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
ABBV-155
Intravenous (IV) Infusion
Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer
Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.
ABBV-155
Intravenous (IV) Infusion
Paclitaxel
Intravenous (IV) Infusion
Expansion 2b: ABBV-155 + docetaxel in NSCLC
Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.
ABBV-155
Intravenous (IV) Infusion
Docetaxel
Intravenous (IV) Infusion
Interventions
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ABBV-155
Intravenous (IV) Infusion
Paclitaxel
Intravenous (IV) Infusion
Docetaxel
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* 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) including the safety lead-in phase (Japan only).
* 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. Participants with activating mutations in EGFR, ALK/ROS1, BRAF genes, or with positive expression of PD-L1 must have been treated with the appropriate targeted therapies.
* 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
* 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).
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham - Main /ID# 214024
Birmingham, Alabama, United States
Highlands Oncology Group, PA /ID# 201568
Springdale, Arkansas, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105
Orange, California, United States
Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267
West Hollywood, California, United States
Univ of Colorado Cancer Center /ID# 208365
Aurora, Colorado, United States
Yale University, Yale Cancer Center /ID# 201542
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 227242
Orlando, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 201563
Chicago, Illinois, United States
Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095
Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 201320
Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 201564
Boston, Massachusetts, United States
Duplicate_Henry Ford Hospital /ID# 226852
Detroit, Michigan, United States
Northwell Health - Marcus Ave /ID# 204376
New Hyde Park, New York, United States
Carolina BioOncology Institute /ID# 201577
Huntersville, North Carolina, United States
Univ Hosp Cleveland /ID# 201567
Cleveland, Ohio, United States
University of Oklahoma, Stephenson Cancer Center /ID# 206820
Oklahoma City, Oklahoma, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256
Providence, Rhode Island, United States
Vanderbilt Ingram Cancer Center /ID# 201575
Nashville, Tennessee, United States
Mary Crowley Cancer Research /ID# 214168
Dallas, Texas, United States
MD Anderson Cancer Center /ID# 201558
Houston, Texas, United States
NEXT Oncology /ID# 204893
San Antonio, Texas, United States
Peter MacCallum Cancer Center /ID# 241676
Melbourne, New South Wales, Australia
Duplicate_Cross Cancer Institute /ID# 213838
Edmonton, Alberta, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 204539
Toronto, Ontario, Canada
The Chaim Sheba Medical Center /ID# 230812
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 230813
Haifa, , Israel
National Cancer Center Hospital East /ID# 215130
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 215003
Chuo-ku, Tokyo, Japan
Maastricht Universitair Medisch Centrum /ID# 225220
Maastricht, Limburg, Netherlands
Antoni van Leeuwenhoek /ID# 222260
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum /ID# 222341
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Utrecht /ID# 222357
Utrecht, , Netherlands
Pan American Center for Oncology Trials, LLC /ID# 232128
Rio Piedras, , Puerto Rico
National Cancer Center /ID# 241095
Goyang-si, Gyeonggido, South Korea
Yonsei University Health System Severance Hospital /ID# 240648
Seoul, , South Korea
Hospital Universitario Fundacion Jimenez Diaz /ID# 239997
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 239999
Madrid, , Spain
National Taiwan University Hospital /ID# 205673
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 214062
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 206304
Tainan, , Taiwan
Countries
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Other Identifiers
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2020-002495-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-573
Identifier Type: -
Identifier Source: org_study_id
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