Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab

April 12, 2024 updated by: AbbVie

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of ABBV-514 as a monotherapy and in combination with Budigalimab.

Budigalimab and ABBV-514 are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of ABBV-514 will be explored. Each treatment arm receives a different dose of ABBV-514 in monotherapy and in combination with Budigalimab. Approximately 215 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive ABBV-514 as a monotherapy or in combination with Budigalimab as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

215

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 252287
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus /ID# 238333
      • Haifa, H_efa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center /ID# 250497
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 238332
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital /ID# 250405
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 238840
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital /ID# 250409
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center /ID# 250408
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Completed
        • National Cancer Center Hospital /ID# 238372
  • Korea, Republic of
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center /ID# 252290
      • Seongnam City, Gyeonggido, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center /ID# 252291
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 252288
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center /ID# 252289
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois at Chicago /ID# 251750
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
      • Indianapolis, Indiana, United States, 46250-2042
        • Recruiting
        • Community Health Network, Inc. /ID# 243011
    • Kentucky
      • Louisville, Kentucky, United States, 40241-2832
        • Recruiting
        • Norton Cancer Institute /ID# 248903
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina BioOncology Institute /ID# 232597
        • Contact:
          • Site Coordinator
          • Phone Number: 844-663-3742
    • Texas
      • Austin, Texas, United States, 78705-1171
        • Recruiting
        • NEXT Oncology Austin /ID# 243005
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology /ID# 243007
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists - Fairfax /ID# 232592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dose-escalation cohorts only:

    -- Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.

  • Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:

    • Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that is not suitable for surgical resection and / or radiation therapy and has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
    • Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease.
  • Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).
  • Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 1.
  • Laboratory values meeting the criteria outlined in the protocol.

Exclusion Criteria:

- Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:

-- Non-Small Cell Lung Cancer (NSCLC) participants with known EGFR mutations or ALK gene rearrangements are ineligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation: ABBV-514
Participants will receive ABBV-514.
Drug: ABBV-514
Intravenous (IV) Infusion
Experimental: Part 2 Dose Expansion: ABBV-514
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
Drug: ABBV-514
Intravenous (IV) Infusion
Experimental: Part 2 Dose Expansion: ABBV-514 + Budigalimab
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: ABBV-514
Intravenous (IV) Infusion
Experimental: Part 1 Dose Escalation: ABBV-514 + Budigalimab
Participants will receive ABBV-514 in combination with budigalimab.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: ABBV-514
Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AE)
Time Frame: Up to 2 Years
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 2 Years
Terminal Elimination Half-Life (t1/2) of ABBV-514
Time Frame: Up to 2 Years
Terminal elimination half-life (t1/2) of ABBV-514.
Up to 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Time Frame: Up to 2 Years
Area under the serum concentration versus time curve (AUC) of ABBV-514.
Up to 2 Years
Antidrug Antibody (ADA)
Time Frame: Up to 2 Years
Incidence and concentration of anti-drug antibodies.
Up to 2 Years
Neutralizing Antidrug Antibody (nADA)
Time Frame: Up to 2 Years
Incidence and concentration of neutralizing anti-drug antibodies.
Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-514
Time Frame: Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of of ABBV-514.
Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514
Time Frame: Up to 2 Years
Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514.
Up to 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

May 4, 2026

Study Completion (Estimated)

May 4, 2026

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-410
  • 2021-002715-65 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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