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

A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

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).

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Docetaxel; Drug: ABBV-155; Drug: Paclitaxel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Melbourne, New South Wales, Australia, 3000
      • Peter MacCallum Cancer Center /ID# 241676
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Duplicate_Cross Cancer Institute /ID# 213838
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network_Princess Margaret Cancer Centre /ID# 204539
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 230813
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 230812
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 215130
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 215003
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 222357
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht Universitair Medisch Centrum /ID# 225220
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Antoni van Leeuwenhoek /ID# 222260
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Erasmus Medisch Centrum /ID# 222341
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 232128
• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 240648
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10408
      • National Cancer Center /ID# 241095
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 239997
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 239999
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 214062
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 206304
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 205673
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 214024
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group, PA /ID# 201568
  • California
    • Orange, California, United States, 92868-3201
      • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105
    • West Hollywood, California, United States, 90048
      • Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 208365
  • Connecticut
    • New Haven, Connecticut, United States, 06510-3206
      • Yale University, Yale Cancer Center /ID# 201542
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando /ID# 227242
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 201563
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital /ID# 201320
    • Baltimore, Maryland, United States, 21224
      • Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 201564
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Duplicate_Henry Ford Hospital /ID# 226852
  • New York
    • New Hyde Park, New York, United States, 11042-2060
      • Northwell Health - Marcus Ave /ID# 204376
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute /ID# 201577
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 201567
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • University of Oklahoma, Stephenson Cancer Center /ID# 206820
  • Rhode Island
    • Providence, Rhode Island, United States, 02903-4923
      • Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0021
      • Vanderbilt Ingram Cancer Center /ID# 201575
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research /ID# 214168
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /ID# 201558
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology /ID# 204893

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) 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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escalation 1a: ABBV-155; Participants will be administered ABBV-155 (various doses).	Drug: ABBV-155; Intravenous (IV) Infusion
Experimental: Escalation 1b: ABBV-155 + paclitaxel or docetaxel; Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .	Drug: Docetaxel; Intravenous (IV) Infusion; Drug: ABBV-155; Intravenous (IV) Infusion; Drug: Paclitaxel; Intravenous (IV) Infusion
Experimental: Expansion 2a: ABBV-155 in SCLC; Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).	Drug: ABBV-155; Intravenous (IV) Infusion
Experimental: 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.	Drug: ABBV-155; Intravenous (IV) Infusion; Drug: Paclitaxel; Intravenous (IV) Infusion
Experimental: 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.	Drug: Docetaxel; Intravenous (IV) Infusion; Drug: ABBV-155; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD and/or RPTD of ABBV-155	The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).	Up to approximately 21 days after initial dose of study drug
Overall Response Rate (ORR)	ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 2 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to approximately 12 months
Duration of Response (DOR)	DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first.	Up to approximately 12 months
Rate of Complete Response (CR)	CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1	Up to approximately 2 to 6 months
Progression-Free Survival (PFS)	PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first.	Up to approximately 12 months
Overall Survival (OS)	OS is defined as the number of days from the date of first study drug to the date of death due to any cause.	Up to approximately 12 months after last dose of study drug
Cmax of ABBV-155	Maximum plasma concentration (Cmax).	Up to approximately 48 days
Tmax of ABBV-155	Time to maximum plasma concentration (Tmax).	Up to approximately 48 days
Terminal Phase Elimination Rate constant of ABBV-155	Terminal phase elimination rate constant of ABBV-155	Up to approximately 48 days
AUCt of ABBV-155	Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).	Up to approximately 48 days
AUCinf of ABBV-155	AUC from time 0 to infinite time (AUCinf).	Up to approximately 48 days
QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.	Up to approximately 8 days
t1/2 of ABBV-155	Terminal elimination half-life (t1/2).	Up to approximately 48 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): September 12, 2025
• Study Completion (Actual): September 12, 2025

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Docetaxel; Cancer; breast cancer; Advanced Solid Tumors; Paclitaxel; Taxane; non-small cell lung cancer (NSCLC); small cell lung cancer (SCLC); Relapsed and/or Refractory Solid Tumors; ABBV-155
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Skin Diseases; Breast Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Paclitaxel
• Other Study ID Numbers: M16-573; 2020-002495-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No