At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
DS-8201a 5.4 mg/kg Q3W +1 moredrug
Likely dose
DS-8201a 5.4 mg/kg Q3Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)
In Brief
A Phase 2 clinical trial evaluating DS-8201a 5.4 mg/kg Q3W and DS-8201a 6.4 mg/kg Q3W for Advanced Colorectal Cancer. Completed, enrolled 122 participants across 63 sites in 10 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Colorectal Cancer
CountriesAustralia, Belgium, France, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsAstraZeneca
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartMar 2021
Primary CompletionNov 2022
Study CompletionDec 2024
TodayJul 2026
First PostedFeb 9, 2021
Enrollment StartMar 5, 2021
Primary CompletionNov 1, 2022
Study CompletionDec 4, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago
Interventions
DS-8201a 5.4 mg/kg Q3Wdrug
DS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W)
DS-8201a 6.4 mg/kg Q3Wdrug
DS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W)