Investigational Drug
BMS-986340
TrialFetch AI Analysis
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Overview
BMS-986340 (imzokitug) is an investigational, nonfucosylated human IgG1 monoclonal antibody targeting C-C chemokine receptor 8 (CCR8). It is being developed as a cancer immunotherapy, both alone and in combinations with checkpoint inhibitors, chemotherapy and other agents. (cancer.gov)
As of September 22, 2026, no publicly reported human efficacy or safety results were identified in peer-reviewed publications or major scientific-conference abstracts. The first-in-human phase 1/2 study remains ongoing and lists no results on ClinicalTrials.gov. (clinicaltrials.gov)
Mechanism of action
CCR8 is enriched on immunosuppressive regulatory T cells (Tregs) within tumors. Imzokitug blocks CCR8–CCL1 signaling and is designed to eliminate CCR8-positive Tregs through Fc-mediated antibody-dependent cellular cytotoxicity. Depleting these cells may restore effector T-cell activity against tumors. (cancer.gov)
In preclinical studies, BMS-986340 depleted CCR8-positive Tregs in human tumor explants. Surrogate anti-CCR8 antibodies inhibited tumor growth in mouse models, with additional activity when combined with anti-PD-1 therapy; these findings have not yet established clinical benefit in humans. (aacrjournals.org)
Clinical development
The ongoing first-in-human phase 1/2 study (NCT04895709) is evaluating imzokitug alone and with nivolumab, docetaxel or pumitamig in multiple advanced solid tumors. Additional phase 2 studies are evaluating combinations in microsatellite-stable colorectal cancer, pancreatic adenocarcinoma and first-line advanced non-small-cell lung cancer. (clinicaltrials.gov)
Further reading
- AACR preclinical abstract
- First-in-human phase 1/2 study — ClinicalTrials.gov
- NCI Drug Dictionary entry
- NCATS imzokitug drug record
Last updated: Sep 2026
Active trials using BMS-986340
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with untreated stage IV or recurrent unresectable NSCLC, ECOG 0–1, and no actionable alteration warranting approved first-line targeted therapy are randomized to pumitamig plus histology-directed platinum-doublet chemotherapy with or without imzokitug. Pumitamig targets PD-L1 and VEGF-A; imzokitug targets CCR8 to deplete tumor-infiltrating regulatory T cells.
ClinicalTrials.gov ID: NCT07680764
TrialFetch AI summary: Adults with metastatic or recurrent pancreatic adenocarcinoma, ECOG 0–1, and no prior systemic therapy for metastatic disease receive first-line gemcitabine and nab-paclitaxel plus nivolumab and investigational imzokitug. Imzokitug is an anti-CCR8 antibody designed to deplete CCR8-positive tumor regulatory T cells.
ClinicalTrials.gov ID: NCT07226856
TrialFetch AI summary: Adults with advanced or metastatic solid tumors that have progressed after their most recent therapy receive investigational BMS-986340 alone or with nivolumab or docetaxel. BMS-986340 is an anti-CCR8 antibody designed to deplete tumor regulatory T cells.
ClinicalTrials.gov ID: NCT04895709
