Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05702229

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Led by AstraZeneca · Updated on 2026-05-14

163

Participants Needed

44

Research Sites

332 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

CONDITIONS

Official Title

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of signing the informed consent form
  • Body weight greater than 35 kg
  • No prior treatment for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Measurable target disease based on RECIST 1.1 assessed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate organ and bone marrow function
  • Confirmed Claudin18.2 status from tumor sample collected within the past 24 months or from a fresh biopsy when Substudy 3 or 4 is recruiting
Not Eligible

You will not qualify if you...

  • HER2-positive or indeterminate gastric or GEJ carcinoma
  • Untreated or progressing brain metastases, leptomeningeal disease, or spinal cord compression
  • Uncontrolled ascites
  • Active infections including tuberculosis, HIV, or hepatitis B or C
  • Uncontrolled intercurrent illnesses
  • Active or prior autoimmune or inflammatory disorders needing systemic steroid or immunosuppressive treatment
  • History of another primary cancer
  • Previous treatment with immune-oncology agents
  • Previous treatment with Claudin18.2 targeted therapy or MMAE exposure when Substudy 3 or 4 is open for recruitment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 44 locations

1

Research Site

Los Angeles, California, United States, 90017

Actively Recruiting

2

Research Site

Los Angeles, California, United States, 90095

Withdrawn

3

Research Site

Baton Rouge, Louisiana, United States, 70817

Actively Recruiting

4

Research Site

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

5

Research Site

New Hyde Park, New York, United States, 11042

Withdrawn

6

Research Site

New York, New York, United States, 10028

Withdrawn

7

Research Site

New York, New York, United States, 10065

Actively Recruiting

8

Research Site

New York, New York, United States, 11210

Withdrawn

9

Research Site

Shirley, New York, United States, 11967

Withdrawn

10

Research Site

The Bronx, New York, United States, 10469

Withdrawn

11

Research Site

Pittsburgh, Pennsylvania, United States, 15212

Withdrawn

12

Research Site

Beijing, China, 100142

Actively Recruiting

13

Research Site

Hangzhou, China, 310003

Actively Recruiting

14

Research Site

Hangzhou, China, 310020

Actively Recruiting

15

Research Site

Harbin, China, 150081

Actively Recruiting

16

Research Site

Hefei, China, 230031

Actively Recruiting

17

Research Site

Kunming, China, 650118

Completed

18

Research Site

Wuhan, China, 430079

Actively Recruiting

19

Research Site

Yinchuan, China, 750004

Actively Recruiting

20

Research Site

Zhengzhou, China, 450052

Actively Recruiting

21

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

22

Research Site

Kashiwa, Japan, 227-8577

Actively Recruiting

23

Research Site

Sunto-gun, Japan, 411-8777

Actively Recruiting

24

Research Site

Seoul, South Korea, 03080

Actively Recruiting

25

Research Site

Seoul, South Korea, 03722

Actively Recruiting

26

Research Site

Seoul, South Korea, 05505

Actively Recruiting

27

Research Site

Seoul, South Korea, 06351

Actively Recruiting

28

Research Site

Barcelona, Spain, 08035

Actively Recruiting

29

Research Site

Elche(Alicante), Spain, 03202

Actively Recruiting

30

Research Site

L'Hospitalet de Llobregat, Spain, 08908

Actively Recruiting

31

Research Site

Madrid, Spain, 28007

Actively Recruiting

32

Research Site

Madrid, Spain, 28040

Actively Recruiting

33

Research Site

Santander, Spain, 39008

Actively Recruiting

34

Research Site

Hsinchu, Taiwan, 300

Actively Recruiting

35

Research Site

Kaohsiung City, Taiwan, 80756

Actively Recruiting

36

Research Site

Taichung, Taiwan, 404

Actively Recruiting

37

Research Site

Tainan, Taiwan, 70403

Actively Recruiting

38

Research Site

Taipei, Taiwan, 10002

Actively Recruiting

39

Research Site

Taipei, Taiwan, 11259

Actively Recruiting

40

Research Site

Taoyuan, Taiwan, 333

Actively Recruiting

41

Research Site

Edinburgh, United Kingdom, EH4 2XU

Withdrawn

42

Research Site

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

43

Research Site

London, United Kingdom, EC1M 6BQ

Actively Recruiting

44

Research Site

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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