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Clinical Trials List

Protocol NumberM21-410

Active

2023-07-07 - 2026-07-31

Phase I

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

Trial Applicant

AbbVie
Sponsor

AbbVie
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Chun-Hui Lee 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊無

Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC, HNSCC, and Advanced Solid Tumors

Objectives

To evaluate the safety, tolerability, and PK, and to identify the maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug (ABBV-514) as monotherapy and in combination with budigalimab or bevacizumab.

Test Drug

N/A
N/A

Active Ingredient

ABBV-514
ABBV-181 (Budigalimab)

Dosage Form

N/A
N/A

Dosage

N/A

Endpoints

The primary efficacy endpoint is achievement of confirmed complete response (CR) or partial
response (PR) as assessed by investigators per Response Evaluation Criteria in Solid Tumors
(RECIST), version 1.1.
• duration of response (DOR) for subjects with confirmed CR or PR.
• progression-free survival (PFS).
• Overall Survival (OS)

Inclution Criteria

Pretreatment biopsy or archived tissue sample within 6 months (without interventional treatment during this period)
Eastern Cooperative Oncology Group (ECOG) performance status score ≤1
Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Meets the laboratory test values outlined in the protocol
Non-small cell lung cancer (NSCLC) – Progressed to advanced or metastatic disease, disease progression following standard therapy (including chemotherapy and anti-PD-(L)1 antibody, alone or in combination). If operable genetic alterations are present, targeted therapy options must have been attempted but failed.
Head and neck squamous cell carcinoma (HSNCC) – Advanced/metastatic disease, disease progression following platinum-based and PD-1/PD-L1 therapy in a recurrent or metastatic setting.
Microsatellite stable colorectal cancer (MSS-CRC) – Disease progression following oxaliplatin, irinotecan, fluoropyrimidines, anti-EGFR, VEGF or VEGFR therapy, TAS-102, regorafenib, and not microsatellite unstable high-frequency or mismatch repair deficient. Gastric cancer and gastroesophageal junction adenocarcinoma (GEA) – Advanced/metastatic disease that has progressed after at least one prior cytotoxic chemotherapy regimen, and, where applicable, immune checkpoint inhibitors and/or HER2 therapy.

High-grade serous ovarian cancer (HGSOC) – Serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has progressed after standard therapy and is not suitable for surgical resection. Platinum-resistant patients must have no more than five prior lines of treatment.

Pancreatic adenocarcinoma (PDAC) – Advanced/metastatic disease that has progressed after standard therapy. This includes adenosquamous carcinoma and patients who have undergone Whipple surgery.

Triple-negative breast cancer (TNBC) – Disease that has progressed after >1 line of systemic therapy (must include paclitaxel) and has not received immunotherapy targeting T-cell co-stimulation.

Exclusion Criteria

Pancreatic ductal adenocarcinoma (PDAC) – Exclusion criteria include neuroendocrine or acinar pancreatic cancer, and participants with a history or risk of coagulopathy, deep vein thrombosis (DVT)/pulmonary embolism (PE). No major surgery within 28 days prior to administration. No active autoimmune/immunodeficiency disease (with limited exceptions). Concomitant therapy excludes participants who have received anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapy and experienced grade 3 or higher immune-mediated toxicity, interstitial lung disease, or anaphylactic reactions. Concomitant therapy may also require the absence of significant cardiac defects and/or events. Pregnancy is also excluded. Excluded medications include: anticancer therapy with a half-life of 5 or within 28 days (whichever is shorter), drugs targeting chemokine receptor (CCR) 8, live vaccines, and immunosuppressive drugs (with limited exceptions).

The Estimated Number of Participants

Taiwan

62 participants
Global

512 participants