ABBV-514 / AbbVie - LARVOL DELTA

ABBV-514: an afucosylated CCR8 specific antibody that targets and eliminates key immunosuppressive tumor regulatory T cells (AACR 2025) - P1 | "ABBV-514 is currently being evaluated in a Phase I clinical trial, both as a monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403). The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication."

IO biomarker • Oncology • Solid Tumor • CCR8 • CD8 • GZMK • LAG3

AbbVie Showcases Early Pipeline and Scientific Advances in Oncology at AACR Annual Meeting 2025 (PRNewswire) - "Data for ABBV-969, a novel STEAP1/PSMA dual-targeted antibody-drug conjugate (ADC) in Phase 1 for advanced prostate cancer, will be presented in an oral presentation; Data to be presented on ABBV-514, a novel CCR8 targeting antibody, in Phase 1 for non-small cell lung cancer, head and neck cancer and other solid tumors."

P1 data • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck

CCR8-targeted Treg depletion and PD-1 blockade combine to divert CD8+ T cells from exhaustion associated transcriptional trajectories within the tumor microenvironment (SITC 2024) - P1 | "A human CCR8 specific afucosylated IgG1 antibody (ABBV-514) is currently being evaluated in a Phase I clinical trial both as monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403). All animal studies were reviewed and approved by AbbVie's Institutional Animal Care and Use Committee or Oversight Body (in accordance with national regulations). Animal studies were conducted under an AAALAC accredited program, where veterinary care and oversight was provided to ensure optimal animal care."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • CCR8 • CD8

First-in-human study of ABBV-514 as monotherapy and in combination with budigalimab in patients with advanced solid tumors (ESMO 2023) - P1 | "In dose expansion, patients with R/R non-small cell lung cancer will be enrolled in ABBV-514 monotherapy (N=12) and ABBV-514 + BDG (N=12) cohorts, and patients with R/R head and neck squamous cell carcinoma in an ABBV-514 + BDG (N=12) cohort. Enrollment initiated in November 2021, with 30 patients enrolled as of April 2023."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8

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 ABBV-514 Alone or in Combination With Pembrolizumab or Budigalimab (clinicaltrials.gov) - P1; N=136; Recruiting; Sponsor: AbbVie; Not yet recruiting ➔ Recruiting

Adverse events • Clinical • Combination therapy • Enrollment open • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

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 ABBV-514 Alone or in Combination With Pembrolizumab or Budigalimab (clinicaltrials.gov) - P1; N=136; Not yet recruiting; Sponsor: AbbVie

New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1