RecruitingPhase 1Phase 2NCT04725994

Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer

An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer


Sponsor

Idience Co., Ltd.

Enrollment

100 participants

Start Date

Jun 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety, tolerability, and effectiveness of an investigational drug called IDX-1197 combined with standard chemotherapy regimens in patients with advanced stomach or gastroesophageal junction cancer that has not been previously treated or has progressed after two or more prior treatments. **You may be eligible if:** - You have advanced or metastatic gastric (stomach) or gastroesophageal junction cancer - You either have had no prior treatment for metastatic disease, or you have received two or more prior lines of treatment - Your cancer has at least one measurable lesion - Your overall health status is adequate (ECOG performance status 0 or 1) **You may NOT be eligible if:** - You have brain metastases or cancer spread to the membranes around the brain - You have HER2-positive cancer (applies to the first-line group) - You have uncontrolled diabetes, serious infection, severe heart or lung disease, or high blood pressure - You have HIV, active hepatitis B or C, or a history of a myelodysplastic syndrome - You are taking certain medications that interact with the study drug (CYP3A4 inhibitors/inducers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDX-1197+XELOX

The dose levels will be escalated following a 3+3 dose escalation scheme.

DRUGIDX-1197+Irinotecan

The dose levels will be escalated following a 3+3 dose escalation scheme.


Locations(14)

USC Norris Comp. Cancer Ctr Hospital

Los Angeles, California, United States

Hematology Oncology Clinic Baton Rouge / Sarah Cannon

Baton Rouge, Louisiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Beijing Cancer Hospital

Beijing, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Shanghai East Hospital

Shanghai, China

Dong-A University Hospital

Busan, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Korea University Anam Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT04725994


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