Description:
The main objective of this study is to test the safety and effectiveness of DS-8201a for
participants with HER2-expressing advanced colorectal cancer.
Title
- Brief Title: DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer
- Official Title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
DS8201-A-J203
- SECONDARY ID:
2017-003466-28
- NCT ID:
NCT03384940
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| DS-8201a | Experimental product | DS-8201a Cohort A |
Purpose
The main objective of this study is to test the safety and effectiveness of DS-8201a for
participants with HER2-expressing advanced colorectal cancer.
Detailed Description
At study start, only Cohort A is active.
If, and when, Cohort B and C become active depends on the assessment of benefit and risk
observed in the program.
The sponsor will inform the investigators if, and when, Cohort B and C are active.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| DS-8201a Cohort A | Experimental | Cohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks
This cohort is active at study start. | |
| DS-8201a Cohort B | Experimental | Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks
The sponsor will inform investigators if, and when, this cohort becomes active. | |
| DS-8201a Cohort C | Experimental | Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks
The sponsor will inform investigators if, and when, this cohort becomes active. | |
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 had clinically significant lung disease requiring systemic corticosteroid
treatment within the last 6 months or is suspected of having such a disease based on
imaging in the screening period
- Has spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective response rate (ORR) per imaging assessment |
| Time Frame: | from Cycle 1 Day 1 through disease progression (within 18 months) |
| Safety Issue: | |
| Description: | Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 |
Secondary Outcome Measures
| Measure: | Progression-free survival |
| Time Frame: | within 18 months |
| Safety Issue: | |
| Description: | Percentage of participants still alive without the disease getting worse |
| Measure: | Overall survival (OS) |
| Time Frame: | at 18 months |
| Safety Issue: | |
| Description: | Percentage of participants still alive |
| Measure: | Duration of response |
| Time Frame: | within 18 months |
| Safety Issue: | |
| Description: | Length of time response continued |
| Measure: | Disease control rate (DCR) |
| Time Frame: | within 18 months |
| Safety Issue: | |
| Description: | Percentage of participants with controlled disease |
| Measure: | ORR assessed by the investigator based on RECIST version 1.1 |
| Time Frame: | within 18 months |
| Safety Issue: | |
| Description: | Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1 |
| Measure: | Maximum serum/plasma concentration (Cmax) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a |
| Measure: | Time to Cmax (Tmax) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a |
| Measure: | Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a |
| Measure: | AUC from the time of dosing until day 21 (AUC0-21d) |
| Time Frame: | at Day 21 |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- Oncology
- HER2
- Colorectal cancer
- Antibody drug conjugate
- ADC
Last Updated
January 24, 2018
