Investigational Drug
BMS-986340
TrialFetch AI Analysis
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Overview
Imzokitug (BMS-986340) is Bristol Myers Squibb’s investigational, afucosylated human IgG1 monoclonal antibody directed against CCR8, being developed for advanced solid tumors. A global first‑in‑human Phase 1/2 study (CA052‑002; NCT04895709) is evaluating imzokitug as monotherapy and in combination with nivolumab or docetaxel. As of October 7, 2025, the study remains active/recruiting and no peer‑reviewed human efficacy or safety outcomes for imzokitug have been publicly reported. (bmsclinicaltrials.com)
Mechanism of action
- Target: CCR8, a chemokine receptor enriched on intratumoral regulatory T cells (Tregs). In tumor samples, CCR8 expression correlates strongly with FOXP3 and is largely restricted to FOXP3hi Tregs rather than conventional effector T cells. (aacrjournals.org)
- Modality: Afucosylated anti‑CCR8 IgG1 designed to enhance antibody‑dependent cellular cytotoxicity (ADCC) and deplete CCR8+ Tregs within the tumor microenvironment, thereby relieving immunosuppression and enabling effector T‑cell activity. It also blocks CCR8–CCL1 interaction. (drugs.ncats.io)
- Preclinical data: Anti‑CCR8–mediated Treg depletion led to pro‑inflammatory remodeling of the tumor microenvironment and robust tumor growth inhibition in murine models; BMS‑986340 depleted CCR8+ Tregs in human tumor explants. (aacrjournals.org)
Clinical development
- Trial: CA052‑002 (NCT04895709), Phase 1/2, multi‑part, open‑label study assessing safety, dosing, and preliminary activity of imzokitug alone and with nivolumab or docetaxel across selected solid tumors. Recruitment began in 2021 and remains ongoing across multiple sites. (bmsclinicaltrials.com)
Efficacy
- No human efficacy results for imzokitug have been publicly disclosed in peer‑reviewed journals or major conference abstracts as of October 7, 2025. (bmsclinicaltrials.com)
Safety
- No human safety results for imzokitug have been publicly disclosed in peer‑reviewed journals or major conference abstracts as of October 7, 2025. (bmsclinicaltrials.com)
Further reading
- Preclinical rationale and tumor explant data (AACR abstract). (aacrjournals.org)
- Official BMS trial page for CA052‑002 (NCT04895709). (bmsclinicaltrials.com)
- EU Clinical Trials Register entry (EudraCT 2021‑001188‑26). (ichgcp.net)
- NCATS Drug Record for imzokitug (mechanism details, INN). (drugs.ncats.io)
Note: Other CCR8 antibodies from different sponsors have begun reporting early clinical findings, but those data are not specific to imzokitug and are therefore not summarized here. (ascopubs.org)
Last updated: Oct 2025
Active trials using BMS-986340
Found 2 active trials using this drug:
TrialFetch AI summary: Eligible patients are adults with measurable metastatic or recurrent pancreatic adenocarcinoma (ECOG 0–1) who have not received prior systemic therapy for metastatic disease (adjuvant/neoadjuvant allowed if completed ≥12 months prior) and have adequate organ function. Treatment is first-line nivolumab (anti–PD-1) plus gemcitabine/nab-paclitaxel with added BMS-986340 (imzokitug), an investigational nonfucosylated anti-CCR8 IgG1 designed to block CCR8 and deplete CCR8+ tumor-infiltrating Tregs via ADCC, given in 28-day cycles until progression/toxicity (up to 2 years).
ClinicalTrials.gov ID: NCT07226856
TrialFetch AI summary: Adults with advanced or metastatic solid tumors who have progressed on, or are not candidates for, standard therapies (including anti-PD-1 where appropriate) may be eligible for this trial of BMS-986340, an investigational anti-CCR8 monoclonal antibody targeting tumor-infiltrating regulatory T cells, given as monotherapy or in combination with nivolumab or docetaxel. Patients must have measurable disease, ECOG 0-1, and be able to undergo mandatory tumor biopsies.
ClinicalTrials.gov ID: NCT04895709
