Last updated 52 days ago
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
413 patients around the world
Available in United States, Brazil
AstraZeneca
413Patients around the world
This study is for people with
Gastric cancer
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations.Disease Characteristics:Locally advanced, unresectable, or metastatic disease based on most recent imaging.For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results.For Part 3b and 4b, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results.For Part 1, progression on or after at least one prior trastuzumab-containing regimen. For Part 2, Part 3 and Part 4, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/esophagus with HER2-positive (Part 2 and Part 3 [Arm 3A] and Part 4 [Arm 4A]) or HER2-low (Part 3 [Arm 3B] and Part 4 [Arm 4B]) status.Has measurable target disease assessed by the Investigator based on RECIST version 1.1.Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function.If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
- History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection.Uncontrolled intercurrent illness.History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.Lung-specific intercurrent clinically significant severe illnesses.Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).Has spinal cord compression or clinically active central nervous system metastases.
StudyDG-03
SponsorAstraZeneca
Study typeInterventional
Conditions
Gastric cancer
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04379596
