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New drug combo shows promise in early cancer trial

NCT ID NCT02988960

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests two experimental immunotherapy drugs, ABBV-927 and ABBV-181, in people with advanced solid tumors that have not responded to other treatments. The main goal is to find the safest dose and understand how the drugs move through the body. About 163 participants will receive the drugs alone or together, and researchers will monitor side effects and any tumor shrinkage.

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

163 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Sep 2026

An estimate. End dates often move.

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: * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Participants have adequate bone marrow, kidney and liver function. * Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug. * Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula. * Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN. * Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies. * Participants in all combination therapy arms must have recurrent or metastatic HNSCC or NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy. * The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered. Exclusion Criteria: * Participant must not have an active or prior documented autoimmune disease in the last 2 years. * Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions). * Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis. * Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation. * Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment. * Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy. * Participant must not have a known uncontrolled malignancy of the central nervous system. * Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy. * Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug. * Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug. * Participant is judged by the investigator to have evidence of hemolysis. * For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

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Conditions

The condition(s) this trial relates to.

cancer head and neck squamous cell carcinoma melanoma neoplasm non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Advanced solid tumors cancer

Contacts and locations

Locations

  • Austin Health /ID# 171189

    Heidelberg, Victoria, 3084, Australia

  • Carolina BioOncology Institute /ID# 155265

    Huntersville, North Carolina, 28078, United States

  • Centre Leon Berard /ID# 162663

    Lyon, Rhone, 69373, France

  • Duplicate_Institut Regional du Cancer /ID# 163609

    Montpellier, Herault, 34298, France

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 200127

    Madrid, 28050, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario y Politecnico La Fe /ID# 200975

    Valencia, 46026, Spain

  • Institut Bergonie /ID# 162665

    Bordeaux, Gironde, 33000, France

  • Institut Gustave Roussy /ID# 162666

    Villejuif, Val-de-Marne, 94805, France

  • Massachusetts General Hospital /ID# 155267

    Boston, Massachusetts, 02114, United States

  • National Cancer Center Hospital /ID# 217758

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 216870

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Peninsula Oncology Centre /ID# 164372

    Frankston, Victoria, 3199, Australia

  • Seoul National University Hospital /ID# 166291

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Tennessee Oncology-Nashville Centennial /ID# 158654

    Nashville, Tennessee, 37203-1632, United States

  • The Angeles Clinic and Researc /ID# 156324

    Los Angeles, California, 90025, United States

  • The University of Chicago Medical Center /ID# 155264

    Chicago, Illinois, 60637-1443, United States

  • University Health Network_Princess Margaret Cancer Centre /ID# 200819

    Toronto, Ontario, M5G 2M9, Canada

  • University of Texas MD Anderson Cancer Center /ID# 155263

    Houston, Texas, 77030, United States

  • Virginia Cancer Specialists - Fairfax /ID# 155266

    Fairfax, Virginia, 22031, United States

  • Yonsei University Health System Severance Hospital /ID# 166292

    Seoul, 03722, South Korea

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