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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

DG-03 Trial 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.Check my eligibility

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.See study design

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.

DG-03 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ while on study drug up to study completion, approximately 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Neutrophil Count Decreased

16%

Aspartate Aminotransferase Increased

16%

Hypokalaemia

15%

Asthenia

14%

Abdominal Pain

11%

Pyrexia

11%

Cough

11%

White Blood Cell Count Decreased

11%

Blood Alkaline Phosphatase Increased

10%

Neutropenia

10%

Hypoalbuminaemia

10%

Epistaxis

10%

Gastrooesophageal Reflux Disease

10%

Alanine Aminotransferase Increased

Back Pain

Dyspnoea

Headache

Hyponatraemia

Hypotension

Dizziness

Urinary Retention

Ascites

Pneumonitis

Abdominal Pain Upper

Dysphagia

Covid-19

Insomnia

Thrombocytopenia

Weight Increased

Blood Bilirubin Increased

Acute Kidney Injury

Interstitial Lung Disease

Device Related Infection

Hypophosphataemia

Depression

Flatulence

Mucosal Inflammation

Blood Creatinine Increased

Urinary Tract Infection

Oedema Peripheral

Pneumonia

Disease Progression

Malignant Neoplasm Progression

Colitis

Wound Infection

Covid-19 Pneumonia

Hyperpyrexia

Staphylococcal Infection

Haematemesis

Bacterial Sepsis

Intestinal Obstruction

Animal Bite

Enteritis

Basal Ganglia Infarction

Cerebrovascular Accident

Generalised Tonic-Clonic Seizure

Pulmonary Embolism

Lymphangiosis Carcinomatosa

Tumour Haemorrhage

Bile Duct Stenosis

Hepatotoxicity

Hydronephrosis

Urinary Tract Obstruction

Exposure To Communicable Disease

Device Occlusion

Catheter Site Infection

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab Deruxtecan

DG-03 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

~2560

Fluorouracil (5-FU)

2014

Completed Phase 2

~300

Capecitabine

2013

Completed Phase 3

~3420

Durvalumab

2017

Completed Phase 2

~3870

Trastuzumab deruxtecan

2022

Completed Phase 2

~400

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, TokyoUNKNOWN

1 Previous Clinical Trials

866 Total Patients Enrolled

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,410 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographies is the research endeavor being conducted?

"The trial is now recruiting from 8 different sites, such as Baltimore, Westwood and Houston. For the comfort of patients participating in the study, it's important to choose a nearby location to minimize travel requirements."

Answered by AI

Could I participate in this investigation given my current health status?

"This trial is recruiting 315 individuals between 18 and 130 years old with malignant neoplasm of the stomach. The prerequisites for entry are as follows: advanced, inoperable or disseminated adenocarcinoma of the stomach, GEJ or oesophagus accompanied by HER2 overexpression (IHC 3+ or IHC 2+/ISH+); those taking part in Part 1 must have experienced progression on at least one prior trastuzumab containing regimen; males and females need to be over 18; participants of childbearing potential should agree to use a highly effective form of contraception during treatment; adequate"

Answered by AI

Has the U.S. Food and Drug Administration (FDA) authorized Trastuzumab deruxtecan for public use?

"Given that it is currently in a Phase 2 trial, there exists limited evidence to support the safety of Trastuzumab deruxtecan. Our team at Power consequently assigned this medication a score of 2."

Answered by AI

Does the enrollment criteria for this research study include adults aged 18 or older?

"This medical trial is open to patients aged between 18 and 130 years old. There are 124 trials for minors, while seniors over 65 can choose from 3095 different studies to participate in."

Answered by AI

Is enrollment still underway for this medical experiment?

"The information on clinicaltrials.gov attests to this trial's current recruitment status, with the original post date falling on June 3rd 2020 and a subsequent update taking place October 21st 2022."

Answered by AI

Have any other investigations explored the efficacy of Trastuzumab deruxtecan?

"Presently, there are 2534 clinical trials researching the use of trastuzumab deruxtecan. 605 of these experiments have advanced to Phase 3 and a great majority can be found in Seattle Washington. However, this medicine is being studied at over ten thousand sites globally."

Answered by AI

What afflictions is Trastuzumab deruxtecan typically used to address?

"Trastuzumab deruxtecan is often administered to patients with relapsed or refractory mediastinal large b-cell lymphoma. Beyond that, it can be prescribed for inflammatory breast cancer (IBC), advanced testicular cancer, and recalcitrant fallopian tube carcinoma."

Answered by AI

What results is this investigation attempting to uncover?

"The primary aim of this study, assessed over 24 months from informed consent, is to evaluate Objective Response Rate (ORR). Secondary objectives will include the serum concentration levels for T-DXd, total anti-HER2 antibody and MAAA-1181a in all arms. Additionally, there will be assessments conducted on ADAs present in both T-DXd and durvalumab when applicable as well as a measure of durvalumab presence when combined with T-DXd in certain cases. All participant data collected during these measurements will be presented descriptively."

Answered by AI

How many individuals are being recruited to take part in this research?

"Indeed, the clinical trial is actively recruiting according to information hosted on clinicaltrials.gov. This research was first made available on June 3rd 2020 and recently updated October 21st 2022. The study requires 315 participants from 8 participating sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

2020. "Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04379596.

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