Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a cocktail of immune boosters shrink Hard-to-Treat tumors?

NCT ID NCT03893955

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether combining several investigational immunotherapy drugs, with or without chemotherapy, can safely shrink advanced solid tumors. The study enrolls adults with cancers like non-small-cell lung cancer or triple-negative breast cancer that have progressed on standard treatments. Researchers first find a safe dose, then expand to measure how well the combinations work.

What this could mean

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

Active substance
A combination of investigational immunotherapy drugs (ABBV-927, ABBV-368, budigalimab) with or without chemotherapy
What this could lead to
If successful, this could point toward new combination treatments that shrink or control advanced solid tumors, including lung and triple-negative breast cancers.
What could go wrong
This is an early phase 1 trial, so the main goals are safety and finding the right dose. The combinations may not work, and side effects could be significant.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Mar 2027

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: * Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Dose-Escalation: * Arm A: Participants with an advanced solid tumor who have progressed on standard therapies known to provide clinical benefit and/or participants who have refused or are intolerant of such therapy. * Arm B (non-small-cell-lung-cancer \[NSCLC\]): Participants with histologically or cytologically confirmed NSCLC who previously progressed during or after an anti-programmed cell death (PD)-1 or PD ligand 1 (PD-L1) therapy and a platinum-based regimen in the recurrent or metastatic setting. Dose-Expansion: * Arm 1, 2, and 3 (triple-negative breast cancer \[TNBC\]): Participants with histologically or cytologically confirmed breast adenocarcinoma that is estrogen receptor/progesterone receptor/human epidermal growth factor receptor (HER)2-negative who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting and who are treatment-naïve to immunotherapy. * Arm 4 (TNBC): Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay. * Arm 5 (NSCLC): Participants with histologically or cytologically confirmed NSCLC who previously progressed either during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting. Exclusion Criteria: * Has history of inflammatory bowel disease or pneumonitis. * Has uncontrolled metastases to the central nervous system. * Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable. * Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed. * Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the course of their therapy: * any immune-mediated toxicity of Grade 3 or worse severity * treatment of the toxicity with systemic corticosteroids * any hypersensitivity to the PD-1 or PD-L1-targeting agent * any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumors are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm neoplasm non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced solid tumors Cancer Metastatic solid tumors Non-small cell lung cancer (NSCLC) Triple negative breast cancer (TNBC)

Contacts and locations

Locations

  • AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869

    Paris, 75018, France

  • Carolina BioOncology Institute /ID# 210664

    Huntersville, North Carolina, 28078, United States

  • Centre Jean Perrin /ID# 217911

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard /ID# 217910

    Lyon, Rhone, 69373, France

  • China Medical University Hospital /ID# 221090

    Taichung, 40447, Taiwan

  • Duplicate_Duke Cancer Center /ID# 217641

    Durham, North Carolina, 27710-3000, United States

  • Duplicate_Icon Cancer Centre /ID# 224084

    South Brisbane, Queensland, 4101, Australia

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072

    Fort Wayne, Indiana, 46804, United States

  • Highlands Oncology Group, PA /ID# 218863

    Springdale, Arkansas, 72762, United States

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 212806

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 212805

    Madrid, 28050, Spain

  • Hospital Universitario Vall de Hebron /ID# 212804

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria /ID# 221671

    Málaga, 29010, Spain

  • Institut Curie /ID# 223475

    Paris, Paris, 75248, France

  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880

    Saint-Herblain, Loire-Atlantique, 44805, France

  • Mary Crowley Cancer Research /ID# 210716

    Dallas, Texas, 75230, United States

  • Moffitt Cancer Center /ID# 215037

    Tampa, Florida, 33612-9416, United States

  • NEXT Oncology /ID# 210717

    San Antonio, Texas, 78229, United States

  • National Taiwan University Hospital /ID# 210993

    Taipei, 100, Taiwan

  • St Jude Hospital dba St Joseph /ID# 211130

    Santa Rosa, California, 95403, United States

  • Tennessee Oncology-Nashville Centennial /ID# 221400

    Nashville, Tennessee, 37203-1632, United States

  • The Chaim Sheba Medical Center /ID# 211699

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UPMC Hillman Cancer Ctr /ID# 222747

    Pittsburgh, Pennsylvania, 15232, United States

  • Virginia Cancer Specialists - Fairfax /ID# 210671

    Fairfax, Virginia, 22031, United States

  • Washington University-School of Medicine /ID# 221399

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine /ID# 210678

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.