Clinical trial NCT05005403: 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 Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
Official title: A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With Azirkitug (ABBV-514) as a Single Agent and in Combination With Budigalimab or Bevacizumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Micro Satellite Stable Colorectal Cancer
Gastric/Esophageal Cancer
High-Grade Serous Ovarian Cancer
Pancreatic Cancer
Triple Negative Breast Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
Head and Neck Squamous Cell Carcinoma
HNSCC
Solid Tumors
Budigalimab
ABBV-181
ABBV-514
Micro Satellite Stable Colorectal Cancer
MSS-CRC, Gastric Cancer
Esophageal Cancer
GEA
GEJ
High-Grade Serous Ovarian Cancer
HGSOC
Pancreatic Cancer, PDAC
Triple Negative Breast Cancer
TNBC
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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 (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,.

Bevacizumab is an approved product, while Budigalimab and Azirkitug (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 Azirkitug (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab 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.


Eligibility criteria: Inclusion Criteria:

* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of \<=1
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
* Laboratory values meeting criteria outlined in the protocol
* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.
* HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib and not MSI-h or MMR-deficient
* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy
* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \>5 lines of prior therapy.
* Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.
* Triple Negative Breast Cancer (TNBC) - Progressed after \>1 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation

Exclusion Criteria:

* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE
* No major surgery within 28 days prior to dosing
* No active autoimmune/immunodeficiency disease with limited exceptions
* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events
* Pregnancy
* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions

Primary outcomes:
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to 2 Years
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-514
timeFrame: Up to 2 Years
measure: Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514
timeFrame: Up to 2 Years
measure: Terminal Elimination Half-Life (t1/2) of ABBV-514
timeFrame: Up to 2 Years
measure: Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
timeFrame: Up to 2 Years
measure: Antidrug Antibody (ADA)
timeFrame: Up to 2 Years
measure: Neutralizing Antidrug Antibody (nADA)
timeFrame: Up to 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 251750
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network, Inc. /ID# 243011
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 248903
state: Kentucky
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
state: Nebraska
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 232597
state: North Carolina
city: Austin
country: United States
facility: NEXT Oncology Austin /ID# 243005
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center /ID# 270059
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology /ID# 243007
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 232592
state: Virginia
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 238333
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 238332
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 252287
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 250497
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 250405
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 238840
state: Chiba
city: Kobe
country: Japan
facility: Kobe University Hospital /ID# 250409
state: Hyogo
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 250408
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 238372
state: Tokyo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center /ID# 252290
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 252291
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 252288
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 252289
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
state: Seoul Teugbyeolsi
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 251894
state: Taipei
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital /ID# 252449
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 252262
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 252450
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 252263
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: