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Advanced Solid TumorsPhase 1NCT03595059

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

A Phase 1 study testing ABBV-155, Paclitaxel and Docetaxel in people with Advanced Solid Tumors, run by AbbVie at 40 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABBV-155, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
40 sitesin 10 countries
Study dates
13 Jul 2018to 12 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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).

Trial locations and contacts

40 sites in 10 countries.

40 sites in 10 countries

United States21 sites

  • Univ of Colorado Cancer Center /ID# 208365

    Aurora, Colorado, 80045

  • Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095

    Baltimore, Maryland, 21224

  • Johns Hopkins Hospital /ID# 201320

    Baltimore, Maryland, 21287

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

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute /ID# 201564

    Boston, Massachusetts, 02215

  • Northwestern University Feinberg School of Medicine /ID# 201563

    Chicago, Illinois, 60611-2927

  • Univ Hosp Cleveland /ID# 201567

    Cleveland, Ohio, 44106

  • Mary Crowley Cancer Research /ID# 214168

    Dallas, Texas, 75230

  • Duplicate_Henry Ford Hospital /ID# 226852

    Detroit, Michigan, 48202

  • MD Anderson Cancer Center /ID# 201558

    Houston, Texas, 77030

  • Carolina BioOncology Institute /ID# 201577

    Huntersville, North Carolina, 28078

  • Vanderbilt Ingram Cancer Center /ID# 201575

    Nashville, Tennessee, 37232-0021

  • Yale University, Yale Cancer Center /ID# 201542

    New Haven, Connecticut, 06510-3206

  • Northwell Health - Marcus Ave /ID# 204376

    New Hyde Park, New York, 11042-2060

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

    Oklahoma City, Oklahoma, 73104-5418

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

    Orange, California, 92868-3201

  • AdventHealth Orlando /ID# 227242

    Orlando, Florida, 32803

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

    Providence, Rhode Island, 02903-4923

  • NEXT Oncology /ID# 204893

    San Antonio, Texas, 78229

  • Highlands Oncology Group, PA /ID# 201568

    Springdale, Arkansas, 72762

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

    West Hollywood, California, 90048

Other trials in United States

Netherlands4 sites

  • Antoni van Leeuwenhoek /ID# 222260

    Amsterdam, North Holland, 1066 CX

  • Maastricht Universitair Medisch Centrum /ID# 225220

    Maastricht, Limburg, 6229 HX

  • Erasmus Medisch Centrum /ID# 222341

    Rotterdam, South Holland, 3015 CE

  • Universitair Medisch Centrum Utrecht /ID# 222357

    Utrecht, 3584 CX

Other trials in Netherlands

Taiwan3 sites

  • China Medical University Hospital /ID# 214062

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 206304

    Tainan, 704

  • National Taiwan University Hospital /ID# 205673

    Taipei City, Taipei, 100

Other trials in Taiwan

Canada2 sites

  • Duplicate_Cross Cancer Institute /ID# 213838

    Edmonton, Alberta, T6G 1Z2

  • University Health Network_Princess Margaret Cancer Centre /ID# 204539

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Israel2 sites

  • Rambam Health Care Campus /ID# 230813

    Haifa, 3109601

  • The Chaim Sheba Medical Center /ID# 230812

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Japan2 sites

  • National Cancer Center Hospital /ID# 215003

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 215130

    Kashiwa-shi, Chiba, 277-8577

Other trials in Japan

South Korea2 sites

  • National Cancer Center /ID# 241095

    Goyang-si, Gyeonggido, 10408

  • Yonsei University Health System Severance Hospital /ID# 240648

    Seoul, 03722

Other trials in South Korea

Spain2 sites

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 239997

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 239999

    Madrid, 28041

Other trials in Spain

Australia1 site

  • Peter MacCallum Cancer Center /ID# 241676

    Melbourne, New South Wales, 3000

Other trials in Australia

Puerto Rico1 site

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

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: 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).

Read the detailed description

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

Being tested
ABBV-155, Paclitaxel, Docetaxel
Keywords
Cancer, Advanced Solid Tumors, Relapsed and/or Refractory Solid Tumors, ABBV-155, Taxane, Paclitaxel, Docetaxel, breast cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC)
Medical subject headings
Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-155Drug

    Intravenous (IV) Infusion

  • PaclitaxelDrug

    Intravenous (IV) Infusion

  • DocetaxelDrug

    Intravenous (IV) Infusion

Study groups in NCT03595059
Study groupRoleWhat they receive
Escalation 1a: ABBV-155ExperimentalParticipants will be administered ABBV-155 (various doses).
Receives: Drug: ABBV-155
Escalation 1b: ABBV-155 + paclitaxel or docetaxelExperimentalParticipants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Receives: Drug: ABBV-155; Drug: Paclitaxel; Drug: Docetaxel
Expansion 2a: ABBV-155 in SCLCExperimentalDescription: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
Receives: Drug: ABBV-155
Expansion 2b: ABBV-155 + paclitaxel in Breast CancerExperimentalParticipants 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.
Receives: Drug: ABBV-155; Drug: Paclitaxel
Expansion 2b: ABBV-155 + docetaxel in NSCLCExperimentalParticipants 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.
Receives: Drug: ABBV-155; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 21 days after initial dose of study drug

  2. 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.

    Measured: Up to approximately 2 to 6 months

Secondary outcomes (12)

  1. 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.

    Measured: Up to approximately 12 months

  2. 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.

    Measured: Up to approximately 12 months

  3. Rate of Complete Response (CR)

    CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1

    Measured: Up to approximately 2 to 6 months

  4. 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.

    Measured: Up to approximately 12 months

  5. 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.

    Measured: Up to approximately 12 months after last dose of study drug

  6. Cmax of ABBV-155

    Maximum plasma concentration (Cmax).

    Measured: Up to approximately 48 days

  7. Tmax of ABBV-155

    Time to maximum plasma concentration (Tmax).

    Measured: Up to approximately 48 days

  8. Terminal Phase Elimination Rate constant of ABBV-155

    Terminal phase elimination rate constant of ABBV-155

    Measured: Up to approximately 48 days

  9. 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).

    Measured: Up to approximately 48 days

  10. AUCinf of ABBV-155

    AUC from time 0 to infinite time (AUCinf).

    Measured: Up to approximately 48 days

  11. QTcF Change from Baseline

    QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.

    Measured: Up to approximately 8 days

  12. t1/2 of ABBV-155

    Terminal elimination half-life (t1/2).

    Measured: Up to approximately 48 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2018
  2. Study start13 Jul 2018
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03595059
Sponsor's protocol ID
M16-573
Other IDs
2020-002495-12
Status last verified
Dec 2025
First submitted
12 Jul 2018
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-155, Paclitaxel and Docetaxel in people with Advanced Solid Tumors, run by AbbVie at 40 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Netherlands, Taiwan, Canada, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD and/or RPTD of ABBV-155 (time frame: Up to approximately 21 days after initial dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03595059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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