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

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

Eligibility

Inclusion Criteria:

* 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
  * 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.

Exclusion Criteria:

* 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.
  * 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

Conditions9

Interventions3

Locations7 sites

Find trials near these locations

Related trials

• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO — National Cancer Institute (NCI)
• A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study — LaNova Medicines Zhejiang Co., Ltd.
• A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG) — Daniel Morgenstern
• A Study of TRK-950 in Patients With Advanced Solid Tumors — Toray Industries, Inc
• A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors — Transcenta Therapeutics (Hangzhou) Co., Ltd.
• Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma — Gustave Roussy, Cancer Campus, Grand Paris
• Agnostic Therapy in Rare Solid Tumors — Instituto do Cancer do Estado de São Paulo
• Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study) — Melanoma Institute Australia

Browse More Trials