A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Study Identifier:
M21-410
CT.gov Identifier:
NCT05005403
EudraCT Identifier:
2021-002715-65
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

To assess adverse events and pharmacokinetics of ABBV-514 as a monotherapy and in combination with Pembrolizumab or Budigalimab.

The Recommended Phase II dose (RP2D) of ABBV-514 will be explored

To evaluates safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-514 as monotherapy and in combination with budigalimab (BDG), a PD-1–blocking antibody.

Patients are treated until disease progression or intolerable toxicity.

Evaluate the safety, tolerability, and PK of ABBV-514 when administered alone or in combination with budigalimab, and determine the MTD/MAD of ABBV-514.

Evaluate the immunogenicity of ABBV-514 when administered alone or in combination with budigalimab.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Head & Neck
  • Bowel (Colorectal)
  • Gastric
  • Ovarian
  • Pancreas
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm Experimental: Experimental: Part 1 Dose Escalation: Azirkitug
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Head & Neck
    Bowel (Colorectal)
    Gastric
    Ovarian
    Pancreas
    Breast Cancers
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Head & Neck
    Bowel (Colorectal)
    Gastric
    Ovarian
    Pancreas
    Breast Cancers
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Head & Neck
    Bowel (Colorectal)
    Gastric
    Ovarian
    Pancreas
    Breast Cancers