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

Recruiting in Palo Alto (17 mi)

+66 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Daiichi Sankyo, Inc.

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).

Eligibility Criteria

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.

Inclusion Criteria

- Presence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

I am fully active or can carry out light work.

- Has left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.

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Exclusion Criteria

I have cancer cells in the fluid around my brain and spinal cord.

I have had a lung removed.

I do not have severe lung problems like bad asthma, COPD, or recent lung clots.

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Treatment Details

Interventions

Trastuzumab Deruxtecan (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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).

Trastuzumab Deruxtecan is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

🇺🇸 Approved in United States as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
HER2-low breast cancer

🇯🇵 Approved in Japan as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma