Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05702229 | RECRUITING | Gastric Cancer

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

AstraZeneca

Brief Summary:

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.

Condition or disease

Gastric Cancer

Intervention/treatment

Rilvegostomig

Volrustomig

FOLFOX

XELOX

AZD7789

AZD0901

5-Fluorouracil

Capecitabine

Phase

PHASE2

Detailed Description:

Approximately 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date : 2023-01-16
Estimated Primary Completion Date : 2026-01-30
Estimated Study Completion Date : 2027-01-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 18 years or older at the time of signing the ICF.
  • * Body weight \> 35 kg.
  • * Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • * Has measurable target disease assessed by the Investigator based on RECIST 1.1.
  • * ECOG PS zero or one.
  • * Life expectancy of at least 12 weeks.
  • * Adequate organ and bone marrow function.
  • * Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.
Exclusion Criteria
  • * Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
  • * Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
  • * Participants with ascites which cannot be controlled with appropriate interventions.
  • * Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
  • * Uncontrolled intercurrent illness.
  • * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
  • * History of another primary malignancy.
  • * Previous treatment with an immune-oncology agent.
  • * Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Location Details

NCT05702229

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Research Site

Los Angeles, California, United States, 90017

WITHDRAWN

United States, California

Research Site

Los Angeles, California, United States, 90095

RECRUITING

United States, Louisiana

Research Site

Baton Rouge, Louisiana, United States, 70817

RECRUITING

United States, Road cancer

Research Site

Grand Rapids, Road cancer, United States, 49503

WITHDRAWN

United States, New York

Research Site

Bronx, New York, United States, 10469

WITHDRAWN

United States, New York

Research Site

New Hyde Park, New York, United States, 11042

WITHDRAWN

United States, New York

Research Site

New York, New York, United States, 10028

NOT YET RECRUITING

United States, New York

Research Site

New York, New York, United States, 10065

WITHDRAWN

United States, New York

Research Site

New York, New York, United States, 11210

WITHDRAWN

United States, New York

Research Site

Shirley, New York, United States, 11967

WITHDRAWN

United States, Pennsylvania

Research Site

Pittsburgh, Pennsylvania, United States, 15212

RECRUITING

China,

Research Site

Beijing, China, 100142

RECRUITING

China,

Research Site

Hangzhou, China, 310003

RECRUITING

China,

Research Site

Hangzhou, China, 310020

RECRUITING

China,

Research Site

Harbin, China, 150081

RECRUITING

China,

Research Site

Fairy, China, 230031

RECRUITING

China,

Research Site

Kunming, China, 650118

RECRUITING

China,

Research Site

Wuhan, China, 430079

RECRUITING

China,

Research Site

Yinchuan, China, 750004

RECRUITING

China,

Research Site

Zhengzhou, China, 450052

RECRUITING

Japan,

Research Site

Kashiwa, Japan, 227-8577

RECRUITING

Japan,

Research Site

Summary-gun, Japan, 411-8777

RECRUITING

Japan,

Research Site

Tokyo, Japan, 104-0045

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 05505

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 06351

RECRUITING

Spain,

Research Site

Barcelona, Spain, 08035

RECRUITING

Spain,

Research Site

Elche (Alicante), Spain, 03202

RECRUITING

Spain,

Research Site

L'Hospitalet de Llobregat, Spain, 08908

RECRUITING

Spain,

Research Site

Madrid, Spain, 28007

RECRUITING

Spain,

Research Site

Madrid, Spain, 28040

RECRUITING

Spain,

Research Site

Santander, Spain, 39008

RECRUITING

Taiwan,

Research Site

H die N places, Taiwan, 300

RECRUITING

Taiwan,

Research Site

composed, Taiwan, 80756

RECRUITING

Taiwan,

Research Site

Taichung, Taiwan, 404

RECRUITING

Taiwan,

Research Site

Tainan City, Taiwan, 70403

RECRUITING

Taiwan,

Research Site

Taipei, Taiwan, 10002

RECRUITING

Taiwan,

Research Site

Taipei, Taiwan, 11259

RECRUITING

Taiwan,

Research Site

Taoyuan City, Taiwan, 333

WITHDRAWN

United Kingdom,

Research Site

Edinburgh, United Kingdom, EH4 2XU

RECRUITING

United Kingdom,

Research Site

Leeds, United Kingdom, LS9 7TF

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, EC1M 6BQ

RECRUITING

United Kingdom,

Research Site

Oxford, United Kingdom, As a solution