RECRUITING

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

Description

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

Conditions

Gastroesophageal Adenocarcinoma
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Related Conditions:

Gastroesophageal Adenocarcinoma

Study Overview

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Study Details

Study overview

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

Condition
Gastroesophageal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Newark

Research Site, Newark, Delaware, United States, 19713

Washington

Research Site, Washington, District of Columbia, United States, 20007

Fairway

Research Site, Fairway, Kansas, United States, 66205

N. Shores

Research Site, N. Shores, Michigan, United States, 49444

New York

Research Site, New York, New York, United States, 10032

New York

Research Site, New York, New York, United States, 10065

Pittsburgh

Research Site, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
  • * Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • * Adequate organ and bone marrow function
  • * Body weight \> 35 kg
  • * Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
  • * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
  • * Central nervous system (CNS) pathology
  • * Uncontrolled infections
  • * Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
  • * History of another primary malignancy
  • * Participants with any known or suspicious distant metastasis
  • * Uncontrolled hepatitis B and/or chronic or active hepatitis B
  • * Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-09-20