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Monoclonal Antibodies

Trastuzumab Deruxtecan for Advanced Colorectal Cancer (DESTINY-CRC02 Trial)

Q: How many different research sites are currently conducting this study?

<p>This particular trial is being conducted at Sarah Cannon (<a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a> <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> - Nashville) in Nashville, Tennessee, University of <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> Health System in Ann Arbor, Michigan, The University of Chicago in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>, and 8 other locations.</p>

Phase 2

Waitlist Available

Research Sponsored by Daiichi Sankyo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Adults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-dose administration to data cut off, up to 40 months

Awards & highlights

DESTINY-CRC02 Trial Summary

This trial will study a new cancer drug for people with HER2-positive colorectal cancer that has spread and cannot be removed by surgery.

Who is the study for?

This trial is for adults with HER2-overexpressing advanced or metastatic colorectal cancer that's not operable. They should have tried certain therapies before, like anti-EGFR if RAS wild-type and anti-VEGF or PD-(L)-1 therapy depending on their tumor type. People can't join if they've had significant lung issues, autoimmune diseases affecting the lungs, a recent heart attack, severe heart failure, uncontrolled arrhythmias, active hepatitis B/C infection, or previous treatment with DXd-containing drugs.Check my eligibility

What is being tested?

The study tests two different doses of Trastuzumab deruxtecan (T-DXd), an experimental drug for colorectal cancer that has spread and expresses high levels of HER2 protein. Participants will receive one of the two dosages every three weeks to assess how well it works and its safety profile.See study design

What are the potential side effects?

Potential side effects include allergic reactions to the infusion; heart problems such as reduced pumping ability; lung issues including inflammation; liver damage indicated by increased enzymes; low blood cell counts leading to higher infection risk; nausea; hair loss; fatigue.

DESTINY-CRC02 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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I am at least 20 years old in Japan, Taiwan, or Korea, or 18 in other countries.

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My cancer is confirmed to highly express HER2.

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My colorectal cancer is advanced, cannot be surgically removed, and does not have BRAF or RAS mutations.

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I have not been treated with fluoropyrimidine, oxaliplatin, or irinotecan, unless it was not suitable for me.

DESTINY-CRC02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-dose administration to data cut off, up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-dose administration to data cut off, up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-dose administration to data cut off, up to 40 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

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer

Secondary outcome measures

Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)

Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29)

Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer

+15 more

DESTINY-CRC02 Trial Design

2Treatment groups

Experimental Treatment

Group I: T-DXd 6.4 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

Group II: T-DXd 5.4 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,262 Previous Clinical Trials

288,595,120 Total Patients Enrolled

Syneos HealthOTHER

172 Previous Clinical Trials

68,332 Total Patients Enrolled

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

415,175 Total Patients Enrolled

Frequently Asked Questions

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

Are we still able to add people to this research project?

"Unfortunately, this study is no longer admitting participants. The listing for this trial was first posted on March 5th, 2021 and was last edited on June 10th, 2022. However, there are 894 other studies for colorectal carcinoma and 37 trials for DS-8201a 5.4 mg/kg Q3W that are still admitting patients."

Answered by AI

What are the risks associated with DS-8201a 5.4 mg/kg Q3W use?

"DS-8201a 5.4 mg/kg Q3W is currently being trialed in Phase 2, which means that while there is not yet data supporting its efficacy, there is data supporting its safety. Our team has given it a score of 2."

Answered by AI

Are there any other ongoing trials that use DS-8201a 5.4 mg/kg given every three weeks?

"DS-8201a 5.4 mg/kg Q3W was first evaluated in 2015 at UC Health Clinical Trials Office. As of now, 5 trials have been completed with 37 more underway; a large portion of these are being conducted in Nashville, Tennessee."

Answered by AI

How many different research sites are currently conducting this study?

"This particular trial is being conducted at Sarah Cannon (Tennessee Oncology - Nashville) in Nashville, Tennessee, University of Michigan Health System in Ann Arbor, Michigan, The University of Chicago in Chicago, Illinois, and 8 other locations."

Answered by AI

How many people are currently being enrolled in this trial?

"This study isn't looking for new patients at the moment. According to the most recent update on June 10th, 2022, this study is no longer admitting patients. However, there are 894 other clinical trials for colorectal carcinoma and 37 studies for DS-8201a 5.4 mg/kg Q3W that are still looking for participants."

Answered by AI

Does this research represent a new direction for this treatment method?

"Since 2015, DS-8201a 5.4 mg/kg Q3W has been the focus of 37 active clinical studies in 44 different countries. The first study, which was sponsored by Daiichi Sankyo, Inc., took place in 2015 and involved 292 patients. DS-8201a 5.4 mg/kg Q3W received Phase 1 drug approval after the first study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

2021. "Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04744831.

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