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Antibody-Drug Conjugate

Trastuzumab Deruxtecan for Cancer (DPT02 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of approximately 14 months

Awards & highlights

DPT02 Trial 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.Check my eligibility

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.See study design

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.

DPT02 Trial 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.

Select...

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.

DPT02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of approximately 14 months

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

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

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

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%

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

DPT02 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

2022

Completed Phase 2

~400

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,594,774 Total Patients Enrolled

Daiichi Sankyo Co., Ltd.Industry Sponsor

115 Previous Clinical Trials

48,618 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 A, Part 2 Cohort C, 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

Frequently Asked Questions

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

Who would be eligible to partake in this clinical trial?

"This clinical trial is searching for 268 participants aged 18 to 120 years old who have pancreas cancer. They must also meet any of the following conditions: Cohort 7 (rare tumors expressing HER2, excluding previously mentioned ones); advanced, metastatic or unresectable disease based on latest imaging; biliary tract cancer in Cohort 1; bladder cancer in Cohort 2; cervical cancer in Cohort 3; endometrial cancer in Cohort 4; epithelial ovarian cancers in Cohorts 5 and 6; progressive disorder with no satisfactory alternative treatment option available and prior HER2 targeting therapy allowed."

Answered by AI

Are individuals below the age of 40 considered to partake in this trial?

"The allowable range of ages to enroll in this trial is 18 - 120, as stated by the enrolment criteria."

Answered by AI

Is this experimentation a pioneering endeavor?

"Presently, Trastuzumab deruxtecan is being studied in 36 live trials held across 44 countries and 483 cities. This drug was first tested by Daiichi Sankyo Inc., with a Phase 1 clinical trial that enrolled 292 participants back in 2015; since then, 5 additional studies have been completed."

Answered by AI

How many volunteers have taken part in the clinical trial thus far?

"This trial is not currently receiving new patients, having been last updated on November 21st 2022. However, there are other studies that may fit the bill - 1379 clinical trials for pancreas cancer and 36 research initiatives recruiting participants to use trastuzumab deruxtecan."

Answered by AI

What potential risks might arise from the use of Trastuzumab deruxtecan?

"Our team has assigned Trastuzumab deruxtecan a score of 2, as the Phase 2 clinical trial provides data verifying its safety while lacking evidence that proves efficacy."

Answered by AI

How widely dispersed is this research trial across the US?

"Presently, this trial is available at 19 sites across Canada. These include Kelowna, Harrison and Montreal along with 16 other cities. Prospective patients are encouraged to select the closest site for their convenience in order to reduce travel requirements."

Answered by AI

What research has been conducted on Trastuzumab deruxtecan prior to this trial?

"The initial research on trastuzumab deruxtecan was conducted at UC Health Clinical Trials Office in 2015. Out of the 41 studies completed or currently ongoing, 5 have reached completion and 36 are still running, primarily out of Kelowna, Canada."

Answered by AI

Is enrollment still available for this clinical trial?

"According to the information hosted on clinicaltrials.gov, patient recruitment for this trial has been concluded. The study was published online on August 18th 2020 and last modified November 21st 2022; however, there are presently 1415 other trials that remain open to enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

2020. "A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04482309.

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