Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT05005403
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azirkitug — DRUG
    Intravenous (IV) Infusion
  • Budigalimab — DRUG
    Intravenous (IV) Infusion
  • Bevacizumab — DRUG
    Intravenous (IV) Infusion
  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion

Study Details

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 azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan 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 azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan 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.

Key Dates

Start date
Nov 1, 2021
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
694 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation: Azirkitug
    Participants will receive Azirkitug.
  • Experimental: Part 1 Dose Escalation: Azirkitug + Budigalimab
    Participants will receive Azirkitug in combination with budigalimab.
  • Experimental: Part 2 Dose Expansion: Azirkitug
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
  • Experimental: Part 2 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 3 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 4 Dose Expansion: Azirkitug
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
  • Experimental: Part 4 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug in combination with budigalimab.
  • Experimental: Part 4 Dose Optimization and Randomization: Azirkitug
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
  • Experimental: Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab
    Participants will receive Azirkitug in combination with budigalimab.
  • Experimental: Part 5 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 6 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 7 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 8 Safety Lead In: Azirkitug + Bevacizumab
    Participants will receive Azirkitug in combination with bevacizumab.
  • Experimental: Part 8 Dose Expansion: Azirkitug + Bevacizumab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab.
  • Experimental: Part 9 Dose Expansion: Azirkitug + Budigalimab
    Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
  • Experimental: Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan
    Participants will receive Azirkitug in combination with telisotuzumab adizutecan.
  • Experimental: Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan
    Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan.

Primary Outcome Measure

Number of Participants with Adverse Events (AE) [ Time Frame: Up to 2 Years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 276272DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589IrvineCalifornia92618-
University of Illinois Hospital and Health Sciences System /ID# 251750ChicagoIllinois60607-
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593Fort WayneIndiana46804-
Community Health Network, Inc. /ID# 243011IndianapolisIndiana46250-2042-
Norton Cancer Institute /ID# 248903LouisvilleKentucky40241-2832-
START Midwest /ID# 248685Grand RapidsMichigan49546-7062-
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200MinneapolisMinnesota55455-
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399OmahaNebraska68130-
Duke Cancer Institute /ID# 276267DurhamNorth Carolina27710-
Carolina BioOncology Institute /ID# 232597HuntersvilleNorth Carolina28078
Site Coordinator
844-663-3742
NEXT Oncology Austin /ID# 243005AustinTexas78705-1171-
The University of Texas MD Anderson Cancer Center /ID# 270059HoustonTexas77030-
Next Oncology - Irving /ID# 276254IrvingTexas75039-
NEXT Oncology /ID# 243007San AntonioTexas78229-
South Texas Accelerated Research Therapeutics (START) /ID# 276268San AntonioTexas78229-
Start Mountain Region /ID# 276270West Valley CityUtah84119-
Virginia Cancer Specialists - Fairfax /ID# 232592FairfaxVirginia22031-

Find similar trials in Duarte, CA

By condition
Head and neck cancerLung cancerPancreatic cancerBreast cancer
By specialty
OncologyENTLung oncologyLung diseaseGI oncologyBreast oncologyWomen's health
By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAUniversity of Illinois Hospital and Health Sciences System· Chicago, ILFort Wayne Medical Oncology and Hematology, Inc· Fort Wayne, INCommunity Health Network, Inc.· Indianapolis, INNorton Cancer Institute· Louisville, KY

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