NCT07818018

Brief Summary

The purpose of this study is to find out whether adding the drug 2141-V11 to standard treatment (anti-PD-1 immunotherapy with or without 5-FU) is a safe treatment approach for participants with advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
36mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

Study Start

First participant enrolled

September 4, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2029

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Esophageal CancerAdvanced Esophageal CancerGastric CancerAdvanced Gastric CancerEsophageal AdenocarcinomaGastroesophageal Junction CancerAdvanced Gastroesophageal Junction AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Keywords

Esophageal Canceradvanced esophageal cancerGastric cancerAdvanced Gastric Cancergastroesophageal junction adenocarcinomaAdvanced Gastroesophageal Junction Adenocarcinomaesophageal adenocarcinomagastroesophageal junction cancer26-267Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Evaluate safety of intratumoral 2141-V11

    The primary endpoint of the safety lead-in cohort is safety. Safety is defined as the incidence of dose-limiting toxicities (DLTs) during the 6-week DLT evaluation window.

    6 weeks

Study Arms (2)

Phase Ib

EXPERIMENTAL

Lead-in cohort. The intervention will be considered safe if DLT's are observed in \<2 of the first 6 patients enrolled; the observation of 2 or more DLTs in the first 6 patients will trigger dose deescalation to dose level -1 (3 mg); should this occur, 6 more patients will be enrolled at dose level -1. If 2 or more DLT's are then observed at dose level -1, the study will be paused and accrual will be stopped to reconsider 2141-V11 dosage.

Biological: Intratumoral 2141-V11Biological: NivolumabDrug: Fluoropyrimidine

Phase II

EXPERIMENTAL

Should the intervention prove to be safe, the phase II component can be initiated with an expansion cohort.

Biological: Intratumoral 2141-V11Biological: NivolumabDrug: Fluoropyrimidine

Interventions

Intratumoral 2141-V11BIOLOGICAL

2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.

Phase IIPhase Ib
NivolumabBIOLOGICAL

Nivolumab will be given as an intravenous infusion.

Phase IIPhase Ib
FluoropyrimidineDRUG

5-FU will be administered as a continuous infusion over 48 hours

Phase IIPhase Ib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
  • Locally advanced unresectable or metastaticdisease at diagnosis
  • On first line systemic therapy including fluoropyrimidine + anti-PD-1 therapy for advanced GEA (e.g. FOLFOX + nivolumab) for a minimum of 3 months and no more than 9 months.
  • Platinum chemotherapy included in first line regimen has been discontinued or will be discontinued ≥2 weeks prior to first planned dose of 2141-V11
  • Patients in the safety lead-in cohort must be on 5-FU
  • Primary esophageal, gastric, or gastroesophageal junction tumor intact and visible at time of enrollment (within 1 month of 2141-V11 treatment initiation) on endoscopy
  • Evaluable disease at time of 2141-V11 treatment initiation as defined per RECIST v1.1
  • Able to undergo endoscopy
  • Age 18 years or older
  • ECOG performance status 0 to 1 (See Appendix I for performance status criteria)
  • Adequate organ function as defined by:
  • Absolute neutrophil count ≥1000/mcL
  • Platelets ≥90,000/mcL
  • Hemoglobin ≥8 g/dL
  • Serum creatinine ≤1.5X ULN
  • +3 more criteria

You may not qualify if:

  • Mismatch repair deficient (dMMR) disease by IHC or microsatellite instability (MSI-H) by next-generation sequencing
  • Known HER2-positive disease (IHC 3+ or IHC 2+ and amplification via fluorescence in situ hybridization)
  • Prior radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor
  • Anti-PD-1 therapy in ongoing regimen has been discontinued for any reason
  • Disease progression on frontline therapy
  • Patients with active autoimmune disease requiring ongoing systemic steroids or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment.
  • Ongoing systemic steroids or receipt of systemic steroid therapy exceeding prednisone 10 mg/day or equivalent within 7 days before first dose, except physiologic replacement or short-course premedication (e.g. as antiemetics or CT scan contrast premedication), or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • Patients with active infection on parenteral antibiotics
  • Patients with history of grade 3 or higher immune related adverse events to anti-PD-1 therapy may only be enrolled with the permission of the study PI.
  • Prior treatment before ongoing regimen for any reason with PD-1, PD-L1, or CTLA-4 inhibitors
  • Currently participating in a therapeutic study and receiving study therapy or has participated in a therapeutic study within 4 weeks of the first dose of treatment. Radiographic protocols including protocols with experimental tracers are not considered therapeutic studies and are exempt.
  • Known active central nervous system metastases and/or leptomeningeal disease
  • HIV, HBV, and HCV testing do not need to be performed as part of the study. For patients with known HIV, HBV, and/or HCV infection:
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering at Nassau (Limited protocol activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Samuel Cytryn, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Cytryn, MD

CONTACT

646-888-4896CytrynS@mskcc.org

Seung Eun Lee, MD

CONTACT

212-639-3754LeeS25@mskcc.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

September 4, 2026

Primary Completion (Estimated)

September 4, 2029

Study Completion (Estimated)

September 4, 2029

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)