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Antibody-drug conjugate

Trastuzumab Deruxtecan for Cancer (DPT01 Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0-1
Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until recist v1.1 objective pd, withdrawal of consent, or death by any cause, up to dco date of 25 jan 2023 (approximately 24 months)
Awards & highlights

DPT01 Trial Summary

This trial is testing a new drug to treat cancer that has spread or can't be removed by surgery, and specifically targets HER2 mutations.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors that have specific HER2 mutations and have worsened after previous treatments or lack other options. Participants must be able to provide a tumor sample, have a heart function of at least 50%, and be relatively fit (ECOG 0-1).Check my eligibility
What is being tested?
The study tests Trastuzumab deruxtecan (T-DXd) in patients with unresectable/metastatic solid tumors harboring HER2 mutations. It's an open-label, single-arm Phase II trial allowing prior HER2 therapy.See study design
What are the potential side effects?
Potential side effects of T-DXd may include allergic reactions, hair loss, nausea, fatigue, low blood cell counts increasing infection risk, potential heart damage, lung problems like difficulty breathing or coughing.

DPT01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer cannot be surgically removed, has spread, and has specific HER2 mutations.
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I can provide a tumor sample for HER2 testing.

DPT01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until recist v1.1 objective pd, withdrawal of consent, or death by any cause, up to dco date of 25 jan 2023 (approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until recist v1.1 objective pd, withdrawal of consent, or death by any cause, up to dco date of 25 jan 2023 (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
Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)
Secondary outcome measures
Confirmed ORR as Per RECIST v1.1 Using Investigator Assessment
Disease Control Rate (DCR) as Per RECIST v1.1 Using ICR and Investigator Assessment
Duration of Response (DoR) as Per RECIST v1.1 Using ICR and Investigator Assessment
+7 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
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%
Colitis
1%
Wound Infection
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

DPT01 Trial Design

1Treatment groups
Experimental Treatment
Group I: T-DXdExperimental Treatment1 Intervention
T-DXd monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2022
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,879 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,984 Total Patients Enrolled

Media Library

Trastuzumab deruxtecan (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04639219 — Phase 2
Solid Tumors Research Study Groups: T-DXd
Solid Tumors Clinical Trial 2023: Trastuzumab deruxtecan Highlights & Side Effects. Trial Name: NCT04639219 — Phase 2
Trastuzumab deruxtecan (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04639219 — 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 uppermost limit of participants in this investigation?

"This clinical trial is no longer in active recruitment. It was first posted on December 30th 2020 and lastly edited on September 9th 2022. For those seeking alternative studies, 2374 are available for patients with advanced solid tumors of her2 mutation such as colorectal, urothelial, gastric, hepatobiliary, endometrial, melanoma, ovarian or cervical cancer; 36 trials recruiting participants use Trastuzumab deruxtecan."

Answered by AI

How many facilities are hosting this clinical trial?

"Currently, 11 clinical trial sites are enlisting participants. These locations span Middletown, Harrison and Fairfax among many others. To make the process as easy as possible for volunteers it is advised to choose a facility that is local."

Answered by AI

Could you provide insight into prior investigations of Trastuzumab deruxtecan?

"Trastuzumab deruxtecan was initially investigated in 2015 at UC Health Clinical Trials Office. To date, 5 trials have been concluded and presently there are 36 active trials of which Middletown, New jersey is a major hub for research."

Answered by AI

Could I be eligible to join this medical experiment?

"This medical experiment seeks 102 individuals that are 18 years or older, display advanced solid tumors with HER2 mutation (e.g., colorectal, urothelial, gastric, hepatobiliary, endometrial melanoma), and have an Eastern Cooperative Oncology Group score of 0-1. Prerequisite criteria include prior treatment with a HER2 targeted medication as well as regional regulations regarding age restrictions. Moreover, the participants must present unresectable/metastatic solid tumors determined by Next Generation Sequencing which has not responded to other treatments nor have satisfactory alternatives available."

Answered by AI

Is this investigation still accepting participants?

"This particular trial is not presently recruiting. It was first advertised on December 30th 2020 and last updated on September 9th 2022. For those searching for other options, there are 2374 medical trials actively seeking patients with advanced solid tumors that contain a HER2 mutation (e.g., colorectal, urothelial, gastric hepatobiliary, endometrial melanoma ovarian cervical salivary gland pancreatic breast). Additionally there are 36 clinical studies inviting participants to take part in Trastuzumab deruxtecan treatments."

Answered by AI

Is this clinical experiment the inaugural of its kind?

"Currently, there exist 36 ongoing experiments involving Trastuzumab deruxtecan distributed across 483 cities and 44 nations. The first trial for this medication was launched in 2015 by Daiichi Sankyo Incorporated. Lasting from 2015 to present, the five studies conducted have enrolled a combined 292 individuals and are now at Phase 1 of their drug approval process."

Answered by AI

Is Trastuzumab deruxtecan a secure treatment option for patients?

"Our team at Power rated trastuzumab deruxtecan a 2 on the safety scale due to lacking efficacy data, though there is some information indicating its security."

Answered by AI

Are those younger than 45 years of age able to partake in this trial?

"The study admits individuals between 18 and 120 years of age. There are 300 studies available for minors and 2,225 trials open to seniors beyond the normal retirement age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
2020. "A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639219.
~24 spots leftby Apr 2025
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