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Antibody-Drug Conjugate

Trastuzumab Deruxtecan for Cancer (DPT02 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
Has protocol-defined adequate organ function including cardiac, renal, and hepatic function
Patients in specific cohorts including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, epithelial ovarian cancer, pancreatic cancer, and rare tumors expressing HER2
Must not have
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
Lung-specific intercurrent clinically significant severe illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of approximately 14 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety and efficacy of trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate, in patients with HER2-expressing solid tumors.

Who is the study for?
This trial is for people with certain HER2-expressing tumors, including ovarian, endometrial, biliary tract, and pancreatic cancers. Participants must have advanced or metastatic disease that has worsened after prior treatment or lack other treatment options. They should not have breast, colon, stomach cancer or non-small cell lung cancer and must be free of severe infections and conditions that could affect study participation.
What is being tested?
The trial tests Trastuzumab deruxtecan (T-DXd) in patients with selected HER2-positive tumors to assess its effectiveness and safety. It's an open-label Phase 2 study involving multiple cohorts based on tumor type to see if T-DXd can provide clinical benefits.
What are the potential side effects?
While the specific side effects are not listed here, common side effects of drugs like Trastuzumab deruxtecan may include fatigue, nausea, hair loss, low blood counts leading to increased infection risk or bleeding problems. Organ-specific reactions such as heart or lung issues might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart, kidneys, and liver are functioning well.
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My cancer is one of the specified types and may express HER2.
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My condition worsened after previous treatment or I have no other good treatment options.
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My cancer has spread and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need treatment for fluid buildup in my chest, abdomen, or around my heart.
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I have severe lung-related health issues.
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I have had lung inflammation that needed steroids or currently have lung disease.
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My cancer has a HER2 gene mutation but does not show HER2 protein.
Select...
My cancer is one of the following types: breast, colon, rectum, stomach, gastro-esophageal junction, or non-small cell lung.
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I do not have an infection needing IV drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of approximately 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of approximately 14 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
Objective Response Rate (ORR)
Secondary study objectives
Disease control rate (DCR)
Duration of response (DoR)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
+6 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

12Treatment groups
Experimental Treatment
Group I: Part 2 Cohort EExperimental Treatment1 Intervention
HER2 IHC 2+ or 1+ cervical cancer
Group II: Part 2 Cohort DExperimental Treatment1 Intervention
HER2 IHC 2+ or 1+ ovarian cancer
Group III: Part 2 Cohort CExperimental Treatment1 Intervention
HER2 IHC 2+ or 1+ endometrial cancer
Group IV: Part 2 Cohort BExperimental Treatment1 Intervention
Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
Group V: Part 2 Cohort AExperimental Treatment1 Intervention
Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
Group VI: Part 1 Cohort 7Experimental Treatment1 Intervention
Rare tumors
Group VII: Part 1 Cohort 6Experimental Treatment1 Intervention
Pancreatic cancer
Group VIII: Part 1 Cohort 5Experimental Treatment1 Intervention
Ovarian cancer
Group IX: Part 1 Cohort 4Experimental Treatment1 Intervention
Endometrial cancer
Group X: Part 1 Cohort 3Experimental Treatment1 Intervention
Cervical cancer
Group XI: Part 1 Cohort 2Experimental Treatment1 Intervention
Bladder cancer
Group XII: Part 1 Cohort 1Experimental Treatment1 Intervention
Biliary tract cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,257 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,767 Total Patients Enrolled

Media Library

Trastuzumab deruxtecan (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04482309 — Phase 2
Gynecological Cancers Research Study Groups: Part 2 Cohort C, Part 2 Cohort A, Part 2 Cohort B, Part 1 Cohort 3, Part 1 Cohort 6, Part 1 Cohort 1, Part 2 Cohort E, Part 1 Cohort 2, Part 1 Cohort 4, Part 1 Cohort 5, Part 1 Cohort 7, Part 2 Cohort D
Gynecological Cancers Clinical Trial 2023: Trastuzumab deruxtecan Highlights & Side Effects. Trial Name: NCT04482309 — Phase 2
Trastuzumab deruxtecan (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482309 — Phase 2
~180 spots leftby Jul 2027
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