Phase 2
Completed N=86
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Source: ClinicalTrials.gov NCT03384940 ↗Enrolled (actual)
86
Serious AEs
40.7%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer — 0; 0; 0; 24 Participants
Summary
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
0; 0; 0; 24; 0; 0 | — |
| PRIMARY Number of Participants With Objective Response Rate Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
24; 0; 0; 10; 0; 0 | — |
| SECONDARY Number of Participants With Best Objective Response Based on Investigator (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
0; 0; 0; 25; 0; 0 | — |
| SECONDARY Number of Participants With Objective Response Rate Based on Investigator (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
25; 0; 0; 28; 0; 0 | — |
| SECONDARY Duration of Response (Confirmed and Unconfirmed) Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
7.0; 7.0 | — |
| SECONDARY Disease Control Rate (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
44; 9; 4; 44; 9; 4 | — |
| SECONDARY Progression-Free Survival Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
6.9; 2.1; 1.4 | — |
| SECONDARY Progression-Free Survival at Various Time Points Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
74.4; 38.3; 7.5; 55; 0; 0 | — |
| SECONDARY Overall Survival Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
15.5; 7.3; 7.7 | — |
| SECONDARY Overall Survival at Various Time Points Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer |
86.8; 86.7; 77.0; 73.6; 53.3; 57.8 | — |
| SECONDARY Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
135; 123; 122; 130; 106; 109 | — |
| SECONDARY Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of MAAA-11181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
15.8; 12.9; 15.1 | — |
| SECONDARY Pharmacokinetic Parameter Time to Maximum Serum Concentration (Tmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
1.95; 1.72; 3.00; 1.72; 1.68; 1.93 | — |
| SECONDARY Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
610; 571; 577; 600; 559; 577 | — |
| SECONDARY Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) of MAAA-1181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
60.2; 45.0; 55.1; 59.5; 47.1; 62.5 | — |
| SECONDARY Treatment-Emergent Adverse Events (TEAEs) Reported By ≥20% Of Participants Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer |
53; 15; 18; 37; 9; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
- Has received at least 2 prior regimens of standard treatment
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Exclusion Criteria
- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a medical history of clinically significant lung disease
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Data sourced from ClinicalTrials.gov (NCT03384940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.