← Back to Search

Monoclonal Antibodies

Trastuzumab Deruxtecan for Gastric Cancer

Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
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 up to 23 months (data cut-off)
Awards & highlights

Study Summary

This trial will find out if trastuzumab deruxtecan is safe and works for people with HER2-positive gastric or gastroesophageal cancer.

Who is the study for?
This trial is for adults with HER2-positive gastric or gastroesophageal junction cancer that can't be surgically removed, has spread, or worsened after trastuzumab treatment. Participants must have a measurable lesion and agree to use effective contraception if of reproductive potential.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Trastuzumab deruxtecan in about 80 participants with advanced gastric cancer across North America and the EU. It targets those whose cancer progressed despite previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea, decreased appetite, blood count changes leading to increased infection risk or bleeding tendencies, heart problems like irregular heartbeat or heart failure, and lung issues such as difficulty breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months (data cut-off)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 months (data cut-off) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Secondary outcome measures
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
+2 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%
Aspartate Aminotransferase Increased
16%
Neutrophil Count Decreased
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
9%
Back Pain
9%
Dyspnoea
9%
Headache
8%
Hyponatraemia
8%
Hypotension
8%
Dizziness
6%
Urinary Retention
6%
Ascites
6%
Pneumonitis
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Acute Kidney Injury
5%
Interstitial Lung Disease
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%
Wound Infection
1%
Colitis
1%
Covid-19 Pneumonia
1%
Hyperpyrexia
1%
Staphylococcal Infection
1%
Haematemesis
1%
Bacterial Sepsis
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2022
Completed Phase 2
~580

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,274 Previous Clinical Trials
288,613,342 Total Patients Enrolled
Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
416,222 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,079 Total Patients Enrolled

Media Library

Trastuzumab deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04014075 — Phase 2
Gastric Cancer Research Study Groups: All participants
Gastric Cancer Clinical Trial 2023: Trastuzumab deruxtecan Highlights & Side Effects. Trial Name: NCT04014075 — Phase 2
Trastuzumab deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04014075 — Phase 2

Frequently Asked Questions

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

What is the purpose of this research?

"The primary outcome of this study, to be measured over a period of approximately 30 months, is the percentage of participants with an objective response rate (ORR) based on independent central review following treatment with DS8201a in participants with HER2-positive unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma. Additionally, secondary outcomes including duration of response (DoR), progression-free survival (PFS) based on investigator assessment following treatment with DS8201a in participants with HER2-positive unresectable or metastatic gastric or gastro"

Answered by AI

What are the odds of negative side effects from Trastuzumab deruxtecan?

"Trastuzumab deruxtecan's place on the 1-3 Power safety scale is a 2. This is due to it being a Phase 2 clinical trial, so while there is some evidence of its safety, none exists for its efficacy."

Answered by AI

Can people still sign up for this experiment?

"According to the latest update on clinicaltrials.gov, this trial is not currently recruiting patients. This study was first posted on November 26th, 2019 but has not been updated since August 31st, 2022. There are 824 other trials that are actively looking for patients right now."

Answered by AI

How many study participants are there in total?

"As of right now, this trial is not looking for new patients. However, it was updated recently on August 31st, 2022 and was first posted on November 26th, 2019. There are 787 other trials currently underway for adenocarcinoma and 37 involving Trastuzumab deruxtecan if you're interested in finding an active study."

Answered by AI

Are there multiple research facilities overseeing this data?

"There are 20 sites running this trial, which include UCLA Health in Santa Monica, USC Norris Comprehensive Cancer Center Hospital in Los Angeles, and Massachusetts General Hospital (MGH) in Boston."

Answered by AI

What are the precedent clinical studies for Trastuzumab deruxtecan?

"There are currently 37 separate clinical trials underway for Trastuzumab deruxtecan, 10 of which have reached Phase 3. Though several locations for these trials are in Phoenix, Arizona, there are over 3000 hospitals and research centres around the world testing this medication."

Answered by AI

Has this clinical trial been done before?

"As of now, 37 Trastuzumab deruxtecan clinical trials are ongoing in 487 cities across 44 countries. The first-ever trial for this medication was back in 2015 and involved 292 patients. That study reached its Phase 1 drug approval stage and was sponsored by Daiichi Sankyo, Inc. In the years since then, 5 more trials have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
2019. "DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04014075.
~15 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top