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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

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AbbVie

Status and phase

Enrolling
Phase 1

Conditions

Gastric/Esophageal Cancer
Micro Satellite Stable Colorectal Cancer
Triple Negative Breast Cancer
Pancreatic Cancer
High-Grade Serous Ovarian Cancer
Head and Neck Squamous Cell Carcinoma
Non-Small Cell Lung Cancer

Treatments

Drug: Bevacizumab
Drug: Azirkitug
Drug: Budigalimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05005403
M21-410

Details and patient eligibility

About

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.

Enrollment

512 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

512 participants in 14 patient groups

Part 1 Dose Escalation: Azirkitug (ABBV-514)
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514).
Treatment:
Drug: Azirkitug
Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 2 Dose Expansion: Azirkitug (ABBV-514)
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.
Treatment:
Drug: Azirkitug
Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 4 Dose Expansion: Azirkitug (ABBV-514)
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.
Treatment:
Drug: Azirkitug
Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 5 Dose Expansion: Azirkitug (ABBV-514)
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.
Treatment:
Drug: Azirkitug
Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug
Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab.
Treatment:
Drug: Bevacizumab
Drug: Azirkitug
Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with bevacizumab.
Treatment:
Drug: Bevacizumab
Drug: Azirkitug
Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab
Experimental group
Description:
Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment:
Drug: Budigalimab
Drug: Azirkitug

Trial contacts and locations

29

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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