2141 V11

Shows activity

Also known as:

2141-V11

Cancer types include:

cervical cancer esophageal cancer head and neck cancer stomach cancer

TrialFetch AI Analysis

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Overview

2141-V11 is an investigational, Fc-engineered antibody being studied as a local cancer immunotherapy. Human results have been reported from small, early-phase studies in metastatic solid tumors and non-muscle-invasive bladder cancer. These studies provide preliminary evidence, not proof of benefit in larger or comparative trials. (pmc.ncbi.nlm.nih.gov)

Mechanism of action

The antibody activates CD40, an immune receptor involved in stimulating antigen-presenting cells and antitumor T-cell responses. Its Fc region is engineered to bind more strongly to FcγRIIB, which enhances CD40 agonism. Studies of patient biopsies also found increased immune-cell interactions and tertiary lymphoid structures in some responders. (pmc.ncbi.nlm.nih.gov)

Efficacy

Metastatic solid tumors: In a phase 1 study of intratumoral injections, 2 of 12 treated patients had confirmed complete responses—one with melanoma and one with breast cancer—for a confirmed response rate of 16.7%. Tumor burden decreased in six patients, but shrinkage did not always meet response criteria. Regression was observed in some uninjected lesions as well. (pmc.ncbi.nlm.nih.gov)
BCG-unresponsive non-muscle-invasive bladder cancer: A 2025 conference abstract reported complete responses in 10 of 25 patients (40%) after drug delivery into the bladder. Seven of 19 patients evaluable at six months had a complete response at that time; follow-up analysis was pending. The abstract prints “41.7%” beside 10 of 25, but that fraction is 40%. (aacrjournals.org)

Safety

In the 12-patient metastatic-cancer study, 7 patients had treatment-related adverse events, most commonly fever, chills, and injection-site reactions. All were grade 1–2; no dose-limiting toxicity was observed. Three patients had serious adverse events that investigators did not attribute to treatment, including one death following infection and sepsis. The bladder-cancer abstract reported no grade 3 or higher adverse events or dose-limiting toxicities among 25 patients. These sample sizes are too small to establish the full safety profile. (pmc.ncbi.nlm.nih.gov)

Active trials using 2141 V11

Found 2 active trials using this drug:

A Phase 1b/II Study of Intratumoral CD40 Agonist 2141-V11 in Combination With Anti PD-1 and 5-Fluorouracil Therapy in Patients With Advanced Gastroesophageal Adenocarcinoma

Sponsor: Memorial Sloan Kettering Cancer Center (other) Phase: 1/2 Start date: Sept. 4, 2026

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma are eligible if they have had 3–9 months of first-line fluoropyrimidine plus anti-PD-1 therapy without progression and have an endoscopically accessible primary tumor. Treatment adds intratumoral 2141-V11, an Fc-engineered CD40 agonist antibody, to nivolumab with a fluoropyrimidine (mandatory in the safety lead-in).

ClinicalTrials.gov ID: NCT07818018

Clinical Trial of D2C7-IT + 2141-V11 Combination Immunotherapy Administered Via Convection Enhanced Delivery in Non-enhancing Tumor Post-resection of Recurrent Glioblastoma, Followed by Cervical Perilymphatic Subcutaneous Injections of 2141-V11

Sponsor: Darell Bigner (other) Phase: 1 Start date: March 17, 2025

TrialFetch AI summary: Adults with recurrent IDH-wildtype glioblastoma, prior standard treatment, Karnofsky performance status ≥70, and postoperative non-enhancing disease suitable for infusion receive D2C7-IT plus 2141-V11 by convection-enhanced delivery into residual disease, followed by cervical perilymphatic injections of 2141-V11. D2C7-IT is an EGFR/EGFRvIII-targeted immunotoxin, and 2141-V11 is an Fc-engineered CD40 agonist intended to stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06455605