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CancerPhase 1NCT03893955

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study testing ABBV-927, ABBV-368 and ABBV-181 in people with Cancer and Advanced Solid Tumors, run by AbbVie at 26 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-927, ABBV-368 and ABBV-181
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
26 sitesin 6 countries
Study dates
21 May 2019to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

United States13 sites

  • Mary Crowley Cancer Research /ID# 210716

    Dallas, Texas, 75230

  • Duplicate_Duke Cancer Center /ID# 217641

    Durham, North Carolina, 27710-3000

  • Virginia Cancer Specialists - Fairfax /ID# 210671

    Fairfax, Virginia, 22031

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

    Fort Wayne, Indiana, 46804

  • Carolina BioOncology Institute /ID# 210664

    Huntersville, North Carolina, 28078

  • Tennessee Oncology-Nashville Centennial /ID# 221400

    Nashville, Tennessee, 37203-1632

  • Yale University School of Medicine /ID# 210678

    New Haven, Connecticut, 06510

  • UPMC Hillman Cancer Ctr /ID# 222747

    Pittsburgh, Pennsylvania, 15232

  • NEXT Oncology /ID# 210717

    San Antonio, Texas, 78229

  • St Jude Hospital dba St Joseph /ID# 211130

    Santa Rosa, California, 95403

  • Highlands Oncology Group, PA /ID# 218863

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 221399

    St Louis, Missouri, 63110

  • Moffitt Cancer Center /ID# 215037

    Tampa, Florida, 33612-9416

Other trials in United States

France5 sites

  • Centre Jean Perrin /ID# 217911

    Clermont-Ferrand, 63011

  • Centre Leon Berard /ID# 217910

    Lyon, Rhone, 69373

  • Institut Curie /ID# 223475

    Paris, Paris, 75248

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

    Paris, 75018

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

    Saint-Herblain, Loire-Atlantique, 44805

Other trials in France

Spain4 sites

  • Hospital Universitario Vall de Hebron /ID# 212804

    Barcelona, 08035

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 212806

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro /ID# 212805

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria /ID# 221671

    Málaga, 29010

Other trials in Spain

Taiwan2 sites

  • China Medical University Hospital /ID# 221090

    Taichung, 40447

  • National Taiwan University Hospital /ID# 210993

    Taipei, 100

Other trials in Taiwan

Australia1 site

  • Duplicate_Icon Cancer Centre /ID# 224084

    South Brisbane, Queensland, 4101

Other trials in Australia

Israel1 site

  • The Chaim Sheba Medical Center /ID# 211699

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

About this study

Official title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

Being tested
ABBV-927, ABBV-368, ABBV-181, Carboplatin, Nab-paclitaxel
Keywords
Cancer, Advanced Solid Tumors, Triple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), ABBV-927, ABBV-368, ABBV-181, metastatic solid tumors, dose-escalation, recommended phase 2 dose, budigalimab
Medical subject headings
Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • ABBV-927Drug

    Intravenous (IV) Infusion

  • ABBV-368Drug

    Intravenous (IV) Infusion

  • ABBV-181Drug

    Also called Budigalimab

    Intravenous (IV) Infusion

  • CarboplatinDrug

    Intravenous (IV) Infusion

  • Nab-paclitaxelDrug

    Intravenous (IV) Infusion

Study groups in NCT03893955
Study groupRoleWhat they receive
Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid TumorsExperimentalParticipants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
Receives: Drug: ABBV-927; Drug: ABBV-368
Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimentalParticipants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
Receives: Drug: ABBV-927; Drug: ABBV-368; Drug: ABBV-181
Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBCExperimentalParticipants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
Receives: Drug: ABBV-927; Drug: ABBV-368; Drug: Carboplatin
Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
Receives: Drug: ABBV-927; Drug: ABBV-181; Drug: Carboplatin
Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
Receives: Drug: ABBV-927; Drug: Carboplatin
Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
Receives: Drug: ABBV-927; Drug: ABBV-368; Drug: Nab-paclitaxel
Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimentalParticipants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
Receives: Drug: ABBV-927; Drug: ABBV-368; Drug: ABBV-181

What is being measured

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

  1. Dose Expansion: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to approximately 2 years following the first dose of study drug

  2. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368

    The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.

    Measured: Up to approximately 6 months

  3. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181

    The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.

    Measured: Up to approximately 6 months

Secondary outcomes (6)

  1. Dose-Expansion Phase: Progression-free Survival (PFS)

    PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years since the first dose of study drug

  2. Dose-Expansion Phase: Duration of Response (DOR)

    DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years since the first dose of study drug

  3. Maximum Serum Concentration (Cmax)

    Maximum Serum Concentration (Cmax)

    Measured: Up to approximately 12 weeks after participant's initial dose of study drug

  4. Time to Maximum Observed Serum Concentration (Tmax)

    Time to Maximum Observed Serum Concentration (Tmax)

    Measured: Up to approximately 12 weeks after participant's initial dose of study drug

  5. Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ)

    Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).

    Measured: Up to approximately 12 weeks after participant's initial dose of study drug

  6. Terminal Phase Elimination Half-life (t1/2)

    Terminal Phase Elimination Half-life (t1/2)

    Measured: Up to approximately 4 weeks after participant's initial dose of study drug

Timeline

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

  1. First posted28 Mar 2019
  2. Study start21 May 2019
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893955
Sponsor's protocol ID
M19-037
Other IDs
2019-000478-45, 2019
Status last verified
Aug 2026
First submitted
27 Mar 2019
Last updated
2 Sep 2026
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-927, ABBV-368 and ABBV-181 in people with Cancer and Advanced Solid Tumors, run by AbbVie at 26 sites in 6 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, France, Spain, Taiwan, Australia and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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?

Dose Expansion: Objective Response Rate (ORR) (time frame: Up to approximately 2 years following the first dose of study drug). The study lists 3 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 NCT03893955.

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 2 Sep 2026.

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