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Master protocol of novel agents or combinations as perioperative treatment in participants with locally advanced resectable gastroesophageal adenocarcinoma.
EU CTIS ID: 2024-516909-23-00
What this study is testing
To assess the safety and tolerability of perioperative treatment. To assess the anti-tumor activity of neoadjuvant treatment in terms of pathological response.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Master and Sub 1-3: 1.Participants must be at least 18 or less than 75 years of age at the time of signing the ICF.
- Master and Sub 1-3: 2. Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease.
- Master and Sub 1-3: 3. Participants who are CLDN18.2 positive and HER2 negative in Substudy 1 or HER2 positive in Substudy 2.
- Master and Sub 1-3: 4. ECOG 0 or 1.
- Master and Sub 1-3: 5. Adequate organ and bone marrow function.
- Master and Sub 1-3: 6. Body weight > 35 kg.
You likely can't join if
- Master and Sub 1-3: 1. Participants had any prior anti-cancer treatment for the current gastric, GEJ, or esophageal cancer.
- Master and Sub 1-3: 2. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- Master and Sub 1-3: 3. CNS pathology.
- Master and Sub 1-3: 4. Uncontrolled infection.
- Master and Sub 1-3: 5. Participants with history of (non-infectious) ILD/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis.
- Master and Sub 1-3: 6. History of another primary malignancy.
See the full eligibility criteria
- Master and Sub 1-3: 1.Participants must be at least 18 or less than 75 years of age at the time of signing the ICF.
- Master and Sub 1-3: 2. Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease.
- Master and Sub 1-3: 3. Participants who are CLDN18.2 positive and HER2 negative in Substudy 1 or HER2 positive in Substudy 2.
- Master and Sub 1-3: 4. ECOG 0 or 1.
- Master and Sub 1-3: 5. Adequate organ and bone marrow function.
- Master and Sub 1-3: 6. Body weight > 35 kg.
- Master and Sub 1-3: 1. Participants had any prior anti-cancer treatment for the current gastric, GEJ, or esophageal cancer.
- Master and Sub 1-3: 2. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- Master and Sub 1-3: 3. CNS pathology.
- Master and Sub 1-3: 4. Uncontrolled infection.
- Master and Sub 1-3: 5. Participants with history of (non-infectious) ILD/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis.
- Master and Sub 1-3: 6. History of another primary malignancy.
- Master and Sub 1-3: 7. Participants with any known or suspicious distant metastasis.
- Only for Sub-study 1: 8. Uncontrolled hepatitis B and/or chronic or active hepatitis B.
- Master and Sub 1-3: Prior/Concomitant Therapy:9. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Turkey
- Canada
- United Kingdom
- Georgia
- Taiwan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Turkey; Canada; United Kingdom; Georgia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.