Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (DG-03)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Esophageal Cancer, Carcinoma, HER2, Trastuzumab, Deruxtecan, T-DXd, DS-8201a, Gastroesophageal Cancer
Eligibility Criteria
Inclusion criteria:
- Male and female participants must be at least 18 years of age
Disease Characteristics:
Locally advanced, unresectable, or metastatic disease Pathologically documented adenocarcinoma of the stomach, GEJ or esophagus with HER2 overexpression (IHC 3+ or IHC 2+/ISH+)
For Part 1, progression on or after at least one prior trastuzumab containing Regimen.
For Part 2, previously untreated for unresectable or metastatic adenocarcinoma of the stomach, GEJ or esophagus with HER2 overexpression.
- Has measurable target disease assessed by the Investigator based on RECIST version 1.1
- Has protocol defined adequate 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.
Exclusion criteria:
- History of active primary immunodeficiency, known HIV, active HBV or HCV 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1A
Arm 1B
Arm 1C
Arm 1D(b)
Arm 1E(a)
Arm 1E(b)
Arm 2A
Arm 2B
Arm 2C
Arm 2D
Arm 2E
Arm 2F
Arm 3A
Arm 3B
T-DXd and 5-fluorouracil (5-FU)
T-DXd and capecitabine
T-DXd and durvalumab
T-DXd, capecitabine, and oxaliplatin
T-DXd, 5-FU, and durvalumab
T-DXd, capecitabine, and durvalumab
Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
T-DXd monotherapy
T-DXd, 5-FU or capecitabine
T-DXd, 5-FU or capecitabine, and pembrolizumab
T-DXd and pembrolizumab
T-DXd, chemotherapy (FP) and pembrolizumab
T-DXd, FP and BSP (MEDI5752)
T-DXd, FP and BSP (MEDI5752)