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New cancer drug ABBV-155 enters first human tests

NCT ID NCT03595059

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called ABBV-155, given alone or with standard chemotherapy (paclitaxel or docetaxel), in 168 adults with advanced solid tumors that had come back or stopped responding to treatment. The main goal was to find a safe dose and check for early signs of tumor shrinkage. The study included people with small cell lung cancer, non-small cell lung cancer, and breast cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-155 (a drug given intravenously, alone or with paclitaxel or docetaxel)
What this could lead to
If it works, this could point toward a new treatment option for certain advanced solid tumors like lung or breast cancer.
What could go wrong
This is a very early Phase 1 trial, so the main goals are safety and dosing, not yet proving effectiveness. Many drugs fail at this stage, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

168 people

The number who actually took part.

Started

Jul 2018

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer neoplasm non-small cell lung carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

  • AdventHealth Orlando /ID# 227242

    Orlando, Florida, 32803, United States

  • Antoni van Leeuwenhoek /ID# 222260

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Carolina BioOncology Institute /ID# 201577

    Huntersville, North Carolina, 28078, United States

  • China Medical University Hospital /ID# 214062

    Taichung, 40447, Taiwan

  • Dana-Farber Cancer Institute /ID# 201564

    Boston, Massachusetts, 02215, United States

  • Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267

    West Hollywood, California, 90048, United States

  • Duplicate_Cross Cancer Institute /ID# 213838

    Edmonton, Alberta, T6G 1Z2, Canada

  • Duplicate_Henry Ford Hospital /ID# 226852

    Detroit, Michigan, 48202, United States

  • Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095

    Baltimore, Maryland, 21224, United States

  • Erasmus Medisch Centrum /ID# 222341

    Rotterdam, South Holland, 3015 CE, Netherlands

  • Highlands Oncology Group, PA /ID# 201568

    Springdale, Arkansas, 72762, United States

  • Hospital Universitario 12 de Octubre /ID# 239999

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 239997

    Madrid, 28040, Spain

  • Johns Hopkins Hospital /ID# 201320

    Baltimore, Maryland, 21287, United States

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256

    Providence, Rhode Island, 02903-4923, United States

  • MD Anderson Cancer Center /ID# 201558

    Houston, Texas, 77030, United States

  • Maastricht Universitair Medisch Centrum /ID# 225220

    Maastricht, Limburg, 6229 HX, Netherlands

  • Mary Crowley Cancer Research /ID# 214168

    Dallas, Texas, 75230, United States

  • NEXT Oncology /ID# 204893

    San Antonio, Texas, 78229, United States

  • National Cancer Center /ID# 241095

    Goyang-si, Gyeonggido, 10408, South Korea

  • National Cancer Center Hospital /ID# 215003

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 215130

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 206304

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 205673

    Taipei City, Taipei, 100, Taiwan

  • Northwell Health - Marcus Ave /ID# 204376

    New Hyde Park, New York, 11042-2060, United States

  • Northwestern University Feinberg School of Medicine /ID# 201563

    Chicago, Illinois, 60611-2927, United States

  • Pan American Center for Oncology Trials, LLC /ID# 232128

    Rio Piedras, 00935, Puerto Rico

  • Peter MacCallum Cancer Center /ID# 241676

    Melbourne, New South Wales, 3000, Australia

  • Rambam Health Care Campus /ID# 230813

    Haifa, 3109601, Israel

  • The Chaim Sheba Medical Center /ID# 230812

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105

    Orange, California, 92868-3201, United States

  • Univ Hosp Cleveland /ID# 201567

    Cleveland, Ohio, 44106, United States

  • Univ of Colorado Cancer Center /ID# 208365

    Aurora, Colorado, 80045, United States

  • Universitair Medisch Centrum Utrecht /ID# 222357

    Utrecht, 3584 CX, Netherlands

  • University Health Network_Princess Margaret Cancer Centre /ID# 204539

    Toronto, Ontario, M5G 2M9, Canada

  • University of Alabama at Birmingham - Main /ID# 214024

    Birmingham, Alabama, 35233, United States

  • University of Oklahoma, Stephenson Cancer Center /ID# 206820

    Oklahoma City, Oklahoma, 73104-5418, United States

  • Vanderbilt Ingram Cancer Center /ID# 201575

    Nashville, Tennessee, 37232-0021, United States

  • Yale University, Yale Cancer Center /ID# 201542

    New Haven, Connecticut, 06510-3206, United States

  • Yonsei University Health System Severance Hospital /ID# 240648

    Seoul, 03722, South Korea

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