A Study of 2141-V11 in People With Esophageal, Gastric, or Gastroesophageal Junction Adenocarcinoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07818018
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Esophageal Cancer
  • Advanced Gastric Cancer
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Esophageal Cancer
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Gastroesophageal Junction Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intratumoral 2141-V11 — BIOLOGICAL
    2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.
  • Nivolumab — BIOLOGICAL
    Nivolumab will be given as an intravenous infusion.
  • Fluoropyrimidine — DRUG
    5-FU will be administered as a continuous infusion over 48 hours

Study Details

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

Key Dates

First listed
Sep 14, 2026
Start date
Sep 4, 2026
Status verified
Sep 2026
Primary completion
Sep 4, 2029
Completion
Sep 4, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib
    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.
  • Experimental: Phase II
    Should the intervention prove to be safe, the phase II component can be initiated with an expansion cohort.

Primary Outcome Measure

Evaluate safety of intratumoral 2141-V11 [ Time Frame: 6 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)Basking RidgeNew Jersey07920
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)HarrisonNew York10604
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Samuel Cytryn, MD
[email protected]
646-888-4896
Memorial Sloan Kettering at Nassau (Limited protocol activities)UniondaleNew York11553
Samuel Cytryn, MD
[email protected]
646-888-4896

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Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)· Basking Ridge, NJMemorial Sloan Kettering at Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering at Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering at Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activites)· New York, NY

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