Esophageal CancerPhase 1/2NCT07818018
A Study of 2141-V11 in People With Esophageal, Gastric, or Gastroesophageal Junction Adenocarcinoma
A Phase 1/2 study testing Intratumoral 2141-V11, Nivolumab and Fluoropyrimidine in people with Esophageal Cancer and Advanced Esophageal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Advanced Esophageal Cancer, Gastric Cancer
- What is being tested?
- Intratumoral 2141-V11, Nivolumab and Fluoropyrimidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Sep 2026to 4 Sep 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- Serum total bilirubin ≤1.5X ULN OR Direct bilirubin ≤ULN for participants with total bilirubin levels >1.5X ULN, except patients with Gilbert's disease (≤3X ULN)
- AST and ALT ≤3X ULN
- Albumin ≥3 mg/dL Abbreviations: ALT, alanine aminotransferase; AST, aminotransferase; ULN, upper limit of normal.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, 07920
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
- Recruiting
Memorial Sloan Kettering at Nassau (Limited protocol activities)
Uniondale, New York, 11553
Samuel Cytryn, MD, 646-888-4896, CytrynS@mskcc.org
About this study
Official title: 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
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
- Conditions
- Esophageal Cancer, Advanced Esophageal Cancer, Gastric Cancer, Advanced Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
- Being tested
- Intratumoral 2141-V11, Nivolumab, Fluoropyrimidine
- Keywords
- Esophageal Cancer, advanced esophageal cancer, Gastric cancer, Advanced Gastric Cancer, gastroesophageal junction adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, esophageal adenocarcinoma, gastroesophageal junction cancer, 26-267, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratumoral 2141-V11Biological
2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.
NivolumabBiological
Nivolumab will be given as an intravenous infusion.
FluoropyrimidineDrug
5-FU will be administered as a continuous infusion over 48 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Intratumoral 2141-V11; Biological: Nivolumab; Drug: Fluoropyrimidine |
| Phase II | Experimental | Should the intervention prove to be safe, the phase II component can be initiated with an expansion cohort. Receives: Biological: Intratumoral 2141-V11; Biological: Nivolumab; Drug: Fluoropyrimidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start4 Sep 2026
- Primary completion4 Sep 2029 (estimated)
- Study completion4 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Samuel Cytryn, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818018
- Sponsor's protocol ID
- 26-267
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.