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Chemotherapy

T-DXd Combinations for Stomach Cancer (DG-03 Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while on study drug up to study completion, approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating the safety and preliminary effectiveness of a new cancer drug, trastuzumab deruxtecan (T-DXd), for treating HER2-positive gastric and esophageal cancers. The study will also look at whether T-DXd is more effective when given in combination with other cancer treatments.

Who is the study for?
This trial is for adults with advanced HER2-expressing stomach, GEJ, or esophageal cancer. Participants must have progressed after a trastuzumab regimen (Part 1) or be untreated for metastatic disease (Part 2), and have measurable disease. They need proper organ function and agree to contraception if of reproductive potential. Exclusions include active infections like HIV/HBV/HCV, uncontrolled illnesses, CNS metastases, lung issues like ILD/pneumonitis, and problematic fluid accumulation.
What is being tested?
DESTINY-Gastric03 tests the safety and effectiveness of T-DXd alone or combined with chemotherapy/immunotherapy in advanced gastric cancers expressing HER2. The study aims to find tolerable doses that show anti-tumor activity as a potential new treatment option for patients who haven't received prior therapy for their metastatic disease.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs administered intravenously, fatigue due to treatment burden on the body's resources, digestive disturbances from chemotherapy agents affecting rapidly dividing cells including those lining the gut.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on study drug up to study completion, approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and while on study drug up to study completion, approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Changes from baseline in electrocardiogram (ECG) results
Part 1: Changes from baseline in laboratory parameters
Part 1: Changes from baseline in vital signs
+3 more
Secondary study objectives
Comparison of DCR
Comparison of DoR
Comparison of ORR
+16 more

Side effects data

From 2024 Phase 2 trial • 79 Patients • NCT04014075
65%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Hypokalaemia
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
15%
Asthenia
14%
Abdominal Pain
11%
Cough
11%
Pyrexia
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Epistaxis
10%
Hypoalbuminaemia
10%
Neutropenia
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Dyspnoea
9%
Back Pain
9%
Headache
8%
Hypotension
8%
Hyponatraemia
8%
Dizziness
6%
Pneumonitis
6%
Ascites
6%
Urinary Retention
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Interstitial Lung Disease
5%
Acute Kidney Injury
5%
Device Related Infection
5%
Hypophosphataemia
5%
Depression
5%
Flatulence
5%
Mucosal Inflammation
5%
Blood Creatinine Increased
5%
Urinary Tract Infection
5%
Oedema Peripheral
3%
Pneumonia
3%
Disease Progression
3%
Malignant Neoplasm Progression
1%
Hyperpyrexia
1%
Colitis
1%
Haematemesis
1%
Wound Infection
1%
Bacterial Sepsis
1%
Staphylococcal Infection
1%
Covid-19 Pneumonia
1%
Intestinal Obstruction
1%
Animal Bite
1%
Enteritis
1%
Basal Ganglia Infarction
1%
Cerebrovascular Accident
1%
Generalised Tonic-Clonic Seizure
1%
Pulmonary Embolism
1%
Lymphangiosis Carcinomatosa
1%
Tumour Haemorrhage
1%
Bile Duct Stenosis
1%
Hepatotoxicity
1%
Hydronephrosis
1%
Urinary Tract Obstruction
1%
Exposure To Communicable Disease
1%
Device Occlusion
1%
Catheter Site Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Deruxtecan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Arm 4BExperimental Treatment4 Interventions
T-DXd, Rilvegostomig and 5-FU or capecitabine
Group II: Arm 4AExperimental Treatment4 Interventions
T-DXd, Rilvegostomig and 5-FU or capecitabine
Group III: Arm 3BExperimental Treatment4 Interventions
T-DXd, Volrustomig and 5-FU or capecitabine
Group IV: Arm 3AExperimental Treatment4 Interventions
T-DXd, Volrustomig and 5-FU or capecitabine
Group V: Arm 2FExperimental Treatment4 Interventions
T-DXd, pembrolizumab and 5-FU or capecitabine
Group VI: Arm 2EExperimental Treatment2 Interventions
T-DXd and pembrolizumab
Group VII: Arm 2DExperimental Treatment4 Interventions
T-DXd, pembrolizumab and 5-FU or capecitabine
Group VIII: Arm 2CExperimental Treatment4 Interventions
T-DXd, 5-FU or capecitabine
Group IX: Arm 2BExperimental Treatment1 Intervention
T-DXd monotherapy
Group X: Arm 1E(b)Experimental Treatment3 Interventions
T-DXd, capecitabine, and durvalumab
Group XI: Arm 1E(a)Experimental Treatment3 Interventions
T-DXd, 5-FU, and durvalumab
Group XII: Arm 1D(b)Experimental Treatment3 Interventions
T-DXd, capecitabine, and oxaliplatin
Group XIII: Arm 1CExperimental Treatment2 Interventions
T-DXd and durvalumab
Group XIV: Arm 1BExperimental Treatment2 Interventions
T-DXd and capecitabine
Group XV: Arm 1AExperimental Treatment2 Interventions
T-DXd and 5-fluorouracil (5-FU)
Group XVI: Arm 2AActive Control5 Interventions
Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2890
Fluorouracil (5-FU)
2014
Completed Phase 3
~950
Capecitabine
2013
Completed Phase 3
~4280
Durvalumab
2017
Completed Phase 2
~3750
Trastuzumab deruxtecan
2021
Completed Phase 2
~800
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, TokyoUNKNOWN
2 Previous Clinical Trials
1,486 Total Patients Enrolled
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,198 Total Patients Enrolled

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04379596 — Phase 2
Stomach Cancer Research Study Groups: Arm 4A, Arm 4B, Arm 2B, Arm 1A, Arm 1B, Arm 1C, Arm 1D(b), Arm 1E(a), Arm 1E(b), Arm 2A, Arm 2C, Arm 2D, Arm 2E, Arm 2F, Arm 3A, Arm 3B
Stomach Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04379596 — Phase 2
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379596 — Phase 2
~107 spots leftby Jul 2026
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